C3 GlomerulopathyNCT07331259
CHART-C3G/CLNP023B12011
An observational study of C3 Glomerulopathy and Complement-mediated Kidney Disease, run by Novartis Pharmaceuticals.
Trial summary
This is a non-interventional chart abstraction cohort study with longitudinal follow up. Patients with C3G treated with iptacopan will be enrolled and characterized (i.e., systematically describe and summarize) regarding their medical history and iptacopan use and evaluated for clinical events, outcomes, and… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- C3 Glomerulopathy, Complement-mediated Kidney Disease, Proteinuria
- What is being tested?
- Iptacopan
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥18 years clinically diagnosed with C3G from participating study sites who initiate iptacopan during the period between 31-Mar-2025 and 31-Dec-2025
Who may be able to join
- Clinical diagnosis of C3G (confirmed by biopsy, only if available)
- Aged ≥18 years at time of index date.
- At least 6 months of baseline period preceding index date.
- Users of iptacopan treatment including those who have discontinued iptacopan within the last twelve weeks.
Who cannot join
- Interventional C3G clinical trial participation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
About this study
Official title: C3 Glomerulopathy Patient Characteristics and Treatment Response to Iptacopan in Routine Care: Analysis of Medical Charts (CHART-C3G)
This is a non-interventional chart abstraction cohort study with longitudinal follow up. Patients with C3G treated with iptacopan will be enrolled and characterized (i.e., systematically describe and summarize) regarding their medical history and iptacopan use and evaluated for clinical events, outcomes, and laboratory measurements upon and after iptacopan treatment initiation. Medical charts will be used to obtain secondary pseudonymized patient-level data with reference to 2 time anchors: at index date (date of iptacopan treatment initiation) with baseline covering 12 months prior to index date, and at 12-month follow-up (twelve months after the index date).The observation period includes baseline plus follow-up.
Iptacopan will be used as prescribed by the clinician in accordance with the terms of the marketing authorization. This Novartis-sponsored study, mainly executed by a contract research organization (CRO), will use secondary data from EHR obtained through reference centers/ centers of excellence in glomerular diseases in Germany.
The primary objective of this study is to characterize the demographic and clinical profiles of adult patients diagnosed with C3G upon iptacopan treatment initiation.
Read the detailed description
Until recently, there are no approved disease-specific treatments for C3G, although there is significant interest in the therapeutic potential of complement inhibition.
Iptacopan, the first oral effective targeted disease-modifying proximal complement inhibitor developed by Novartis, has been approved in April 2025 for the treatment of adults with C3G.
The primary objective of this study is to characterize the demographic and clinical profiles of adult patients diagnosed with C3G upon iptacopan treatment initiation.
By analyzing key endpoints such as age, sex, ethnicity, BMI, clinical symptoms, proteinuria, blood pressure, serum creatinine, eGFR, serum C3 levels, and renal histological parameters, we aim to better understand disease progression and treatment outcomes.
Additionally, we will assess CKD stages, history of kidney failure, dialysis status, transplant status, and comorbidities to identify the characteristics of patients treated with iptacopan.
- Being tested
- Iptacopan
- Keywords
- NIS-PDC, Germany, C3G, Iptacopan, estimated Glomerular Filtration Rate
- Medical subject headings
- Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IptacopanOther
Also called LNP023B
There is no treatment allocation for NIS trials. Patients administered Iptacopan by prescription will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Iptacopan | Adult patients with C3G initiating iptacopan treatment in routine care Receives: Other: Iptacopan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics: Number of patients by age
Age at baseline in years
Measured: Baseline
Demographics: Number of patients by sex
Female Male
Measured: Baseline
Demographics: Number of patients by site
Academic hospital Other sites
Measured: Baseline
Demographics: Body mass index
Body mass index reported at baseline, or the closest value before baseline. In the absence of records for body mass index, it can be calculated using records of height and weight.
Measured: Baseline
Demographics: Number of patinets with Biopsy confirming C3G
No Yes
Measured: Baseline
Clinical symptoms: Proteinuria - Number of participants by 24-hour uPCR
No Yes 24-hour uPCR < 1 g/g 24-hour uPCR ≥ 1 g/g
Measured: Baseline
Proteinuria - Number of participants by spot uPCR
No Yes Spot uPCR < 1 g/g Spot uPCR ≥ 1 g/g
Measured: Baseline
Proteinuria, 24-hour uPCR in g/g
Absolute value of uPCR based on a 24-hour urine collection
Measured: Baseline
Proteinuria, spot uPCR in g/g
Absolute value of uPCR based on a spot urine collection
Measured: Baseline
Clinical symptoms: Albuminuria
No Yes
Measured: Baseline
Albuminuria - Number of participants by spot uACR
No Yes
Measured: Baseline
Albuminuria, 24-hour uACR in g/g
Absolute value of uACR based on a 24-hour urine collection
Measured: Baseline
Albuminuria, spot uACR in g/g
No Yes
Measured: Baseline
Clinical symptoms: Number of participants by Hematuria - dipstick results
No Yes Microscopic (≥3RBCs/HPF) Macroscopic (visible to the naked eye)
Measured: Baseline
Hematuria - Number of participants by urinalysis results
0-2 red blood cells
≥3 red blood cells
Measured: Baseline
Hematuria - urinalysis, number of red blood cells
Number of red blood cells detected through urinalysis
Measured: Baseline
Clinical symptoms: Number of participants with presence of edema
Presence of edema. No Yes
Measured: Baseline
Clinical symptoms: Systolic and diastolic blood pressure
Blood pressure measurement
Measured: Baseline
Clinical symptoms: Number of participants with hypertension
Defined as systolic blood pressure ≥140 mmHg or a diastolic blood pressure ≥90 mmHg No Yes
Measured: Baseline
Clinical symptoms: Serum creatinine at baseline
Absolute value of serum creatinine
Measured: Baseline
Clinical symptoms: Reported eGFR at baseline
Based on medical records of eGFR
Measured: Baseline
Clinical symptoms: Number of participants by equation used in reported eGFR at baseline
2021 CKD-EPI creatinine 2021 CKD-EPI creatinine-cystatin C 2012 CKD-EPI cystatin C 2012 CKD-EPI creatinine-cystatin C 2009 CKD-EPI creatinine MDRD (based on creatinine) Cockroft-Gault (based on creatinine) Schwartz equation (based on creatinine) Not specified
Measured: Baseline
Clinical symptoms: Computed eGFR at baseline
eGFR computed in the study analysis
Measured: Baseline
Clinical symptoms: Serum C3 at baseline
Reference range: LLN = 4.33-5.00 μmol/L ULN = 9.05-11.16 μmol/L
Measured: Baseline
Clinical events and outcomes: Time since C3G diagnosis (days/months)
Time since the first C3G diagnosis to baseline
Measured: Baseline
Clinical events and outcomes: Number of participants with Chronic Kidney Disease (CKD) and stage
No Yes Stage 1 Stage 2 Stage 3 Stage 4 Stage 5
Measured: Baseline
Clinical events and outcomes: Number of participants with history of kidney failure
No Yes (either of the categories below) eGFR ≤ 15 History of dialysis History of kidney transplant
Measured: Baseline
Clinical events and outcomes: Number of participants by dialysis status
No Yes Dialysis at diagnosis of C3G Maintenance dialysis Other types
Measured: Baseline
Clinical events and outcomes: Time from C3G diagnosis to dialysis (months)
Concerns only patients with dialysis at or before baseline
Measured: Baseline
Clinical events and outcomes: Time from dialysis to baseline (months)
Concerns only patients with dialysis at or before baseline
Measured: Baseline
Clinical events and outcomes: Number of participants by transplant status at baseline
No (native kidney) Yes Biopsy-confirmed disease in native kidney No evidence of disease recurrence Recurrent disease in transplanted kidney
Measured: Baseline
Clinical events and outcomes: Time from C3G diagnosis to kidney transplant before baseline (months)
Concerns only patients with a kidney transplant (or kidney transplant failure) at or before baseline
Measured: Baseline
Clinical events and outcomes: Time from kidney transplant before baseline to baseline (months)
Concerns only patients with a kidney transplant (or kidney transplant failure) at or before baseline
Measured: Baseline
Clinical events and outcomes: Number of participants with C3G disease recurrence post-transplant and/or transplant failure
Concerns only patients with a kidney transplant (or kidney transplant failure) at or before baseline.
No Yes
Measured: Baseline
Clinical events and outcomes: Number of participants with comorbidities
For example, history of heart failure, history of stroke, diabetes mellitus, dementia, malignancy
Measured: Baseline
Renal histopathological parameters: Number of participants with presence of cysts
No Yes
Measured: Baseline
Renal histopathological parameters: Number of participants with presence of tumors
No Yes
Measured: Baseline
Renal histopathological parameters: Number of participants with presence of interstitial fibrosis or tubular atrophy
Mild Moderate Severe
Measured: Baseline
Renal histopathological parameters: Number of participants with presence of glomerulosclerosis
Mild Moderate Severe
Measured: Baseline
Renal histopathological parameters: Endocapillary hypercellularity
Presence of cells in capillary loops with loop occlusion 0 = 0% (Essentially normal or no lesion)
- = 1-25% (Only a small fraction of loops are occluded by hypercellularity)
- = 26-50% (About one-quarter to half of the loops show occlusion)
- = ≥51% (More than half of the loops are occluded, indicating extensive endocapillary proliferation)
Measured: Baseline
Renal histopathological parameters: Neutrophils in capillary lumens (each glomerulus is scored)
0 = 0% (No neutrophils in any capillary loops of the glomerulus)
- = 1-25% (Mild involvement: neutrophils present in up to ¼ of loops)
- = 26-50% (Moderate involvement: neutrophils in about ¼ to half of loops)
- = ≥51% (Severe involvement: neutrophils in more than half of loops)
Measured: Baseline
Renal histopathological parameters: Mesangial hypercellularity
More than 4 cells in a mesangial area away from the hilum
0 = 0% (No mesangial areas with >4 cells)
- = 1-25% (Mild involvement: 1-25% of mesangial areas show hypercellularity)
- = 26-50% (Moderate involvement: 26-50% of mesangial areas affected)
- = ≥51% (Severe involvement: More than half of mesangial areas show hypercellularity)
Measured: Baseline
Renal histopathological parameters: Necrosis
Necrosis in glomerular pathology refers to active destructive lesions characterized by:
Disruption of the glomerular basement membrane (GBM) Fibrin exudation into Bowman's space or capillary loops Karyorrhexis (fragmentation of nuclei of inflammatory cells) - at least 2 of these 3 lesions need to be present to meet the criteria for necrosis.
0 = 0% (No glomeruli show necrosis)
- = 1-10% (Mild: 1-10% of glomeruli have necrosis)
- = 11-25% (Moderate: 11-25% of glomeruli affected)
- = ≥25% (Severe: More than 25% of glomeruli show necrosis)
Measured: Baseline
Renal histopathological parameters: Cellular or fibrocellular crescents
0 = 0% (No crescents in any glomeruli)
- = 1-10% (Mild: 1-10% of glomeruli have crescents)
- = 11-25% (Moderate: 11-25% of glomeruli affected)
- = >25% (Severe: More than 25% of glomeruli show crescents)
Measured: Baseline
Renal histopathological parameters: Activity index
A score between 0 and 15, calculated by summing up the scores from the activity index parameters above (Endocapillary hypercellularity,. Neutrophils in capillary lumens, Mesangial hypercellularity, Necrosis and Cellular or fibrocellular crescents).
Score 0: No active lesions. The kidney shows chronic changes only, but no ongoing inflammation.
Higher score implies not aggressively active, and kidney damage is likely stable or progressing slowly.
Measured: Baseline
Renal histopathological parameters: score inflammation assessment scale
Both continuous (score inflammation assessment scale) and categorically (none, mild, moderate, severe).
Continuous Scale (Numeric Score)
- Low score (e.g., 0-3) Minimal inflammatory activity
- High score (e.g., ≥9) Extensive active lesions (necrosis, crescents, heavy infiltration)
Categorical Scale (None, Mild, Moderate, Severe)
- None: No significant inflammation; likely chronic or inactive disease.
- Mild: Small, focal involvement; early or controlled disease.
- Moderate: Widespread but not diffuse; active disease needing treatment.
- Severe: Diffuse, aggressive inflammation; high risk of rapid progression to renal failure.
Measured: Baseline
Renal histopathological parameters: Number of participants by typo of inflammation
Type of inflammation: none, mild, moderate, severe
Measured: Baseline
Chronicity index parameters: Number of participants with glomerular (or segmental) sclerosis
0 = ≤10%
- = 11-25%
- = 26-50%
- = ≥51%
Measured: Baseline
Chronicity index parameters: Number of participants with Fibrous crescents
0 = none
- = ≤25%
- = 26-50% 3= >51%
Measured: Baseline
Chronicity index parameters: Number of participants with tubular atrophy
0 = ≤5%
- = 6-25%
- = 26-50%
- = ≥51%
Measured: Baseline
Chronicity index parameters: Number of participants with interstitial fibrosis
0 = ≤5%
- = 6-25%
- = 26-50%
- = ≥51%
Measured: Baseline
Renal histopathological parameters: Chronicity index
A score between 0 and 12, calculated by summing up the scores from the chronicity index parameters above (Glomerular (or segmental) sclerosis, Fibrous crescents, Tubular atrophy and Interstitial fibrosis)
Lower scores indicate less chronic damage, higher scores indicate more scarring and poor prognosis.
0-3 (Minimal to Mild)
→ Very little irreversible damage. Prognosis is generally favorable if activity index is also low.
4-6 (Moderate)
- Significant chronic changes; recovery potential is limited. 7-12 (Severe)
- Extensive scarring; immunosuppression unlikely to reverse damage
Measured: Baseline
Secondary outcomes (96)
Clinical events and outcomes: Number of participants with kindney failure during follow-up
No Yes
Measured: Up to 12 months
Clinical events and outcomes: Time from C3G diagnosis to kidney failure and time from baseline to kidney failure
Concerns only patients with kidney failure during follow-up
Measured: Up to 12 months
Clinical events and outcomes: Number of participants with dialysis during follow-up
No Yes Maintenance dialysis Other types
Measured: Up to 12 months
Clinical events and outcomes:Time from kidney failure to first dialysis (months)
Concerns only patients with dialysis during follow-up
Measured: Up to 12 months
Clinical events and outcomes: Time from baseline to first dialysis (months)
Concerns only patients with dialysis during follow-up
Measured: Up to 12 months
Clinical events and outcomes: Time from kidney failure to maintenance dialysis (months)
Concerns only patients with maintenance dialysis during follow-up
Measured: Up to 12 months
Clinical events and outcomes: Time from C3G diagnosis to maintenance dialysis (months)
Concerns only patients with maintenance dialysis during follow-up
Measured: Up to 12 months
Clinical events and outcomes: Time from baseline to maintenance dialysis (months)
Concerns only patients with maintenance dialysis during follow-up
Measured: Up to 12 months
Clinical events and outcomes: Number of participants with complete remission (controlled) of C3G during follow-up
No Yes
Measured: Up to 12 months
Clinical events and outcomes: Number of participants with nephrotic-range and non-nephrotic range proteinuria during follow-up
Non-nephrotic-range proteinuria (0.15-3.5 g of protein in a 24-hour urine collection) Nephrotic-range proteinuria (> 3.5 g of protein in a 24- hour urine collection)
Measured: Up to 12 months
Clinical events and outcomes: Number of participants with renal relapse, progression to a higher CKD stage, or chronic renal replacement therapy during follow-up
No Yes Renal relapse Progression to a higher CKD stage Chronic renal replacement therapy
Measured: Up to 12 months
Clinical events and outcomes: Number of transplant failures per patient during follow-up
Transplant failure is defined as a follow-up record of either maintenance dialysis, sustained eGFR <15 mL/min/1.73m², or re-transplant
Measured: Up to 12 months
Clinical events and outcomes: Number of participants with CKD and stage at 12-month follow-up
No Yes Stage 1 Stage 2 Stage 3 Stage 4 Stage 5
Measured: Up to 12 months
Clinical events and outcomes: Number of participants by transplant status at 12-month follow-up
No (native kidney) Yes Biopsy-confirmed disease in native kidney No evidence of disease recurrence Recurrent disease in transplanted kidney
Measured: Up to 12 months
Clinical events and outcomes: Number of participants with Kidney transplant during follow-up
No Yes No transplant failure during follow-up Transplant failure during follow-up
Measured: Up to 12 months
Clinical events and outcomes: Time from kidney failure to transplant during follow-up (months)
Concerns only patients with a kidney transplant (or kidney transplant failure) during follow-up
Measured: Up to 12 months
Clinical events and outcomes: Time from transplant during follow-up to post- transplant C3G disease recurrence (months)
Concerns only patients with a kidney transplant (or kidney transplant failure) during follow-up and a post-transplant C3G disease recurrence during follow-up
Measured: Up to 12 months
Clinical events and outcomes: Time from transplant to transplant failure (months)
Concerns only patients with a kidney transplant during follow-up and a transplant failure during follow-up
Measured: Up to 12 months
Clinical events and outcomes: Number of participants with C3G disease recurrence post-transplant and/or transplant failure
Concerns only patients with a kidney transplant (or kidney transplant failure) during follow-up.
No Yes C3G disease recurrence post-transplant Transplant failure C3G disease recurrence post-transplant and transplant failure
Measured: Up to 12 months
Clinical events and outcomes: Time from C3G disease recurrence to transplant failure
Concerns only patients with the combination of kidney transplant during follow-up, C3G disease recurrence post-transplant, and subsequent transplant failure
Measured: Up to 12 months
Clinical events and outcomes: Time from transplant at any time to post- transplant C3G disease recurrence
Concerns patients with a kidney transplant (or kidney failure) at any time, including baseline and follow-up, and post-transplant C3G disease recurrence at any time, including baseline and follow-up
Measured: Up to 12 months
Clinical events and outcomes: Number of participants with death during follow-up
No Yes
Measured: Up to 12 months
Clinical events and outcomes: Number of participants by cause of Death
Concerns only patients with death during follow-up. Kidney failure Infectious disease Cardiovascular disease Other causes
Measured: Up to 12 Months
Laboratory measurements: Serum creatinine or eGFR
Serum creatinine (preferred) or eGFR
Measured: 6 months, 12 months and 24 months before baseline and up to 12 months follow-up
Laboratory measurements: eGFR slope during the 24months prior to baseline
Average eGFR slope computed using baseline computed eGFR and available historical serum creatinine values (preferred) or eGFR
Measured: 24 months prior to baseline and 12 months post baseline
Laboratory measurements: Change in reported eGFR from baseline to 12-month follow-up, mL/min/1.73m
Difference in absolute value of reported eGFR between end of follow-up and baseline
Measured: Baseline, Month 12
Laboratory measurements: Equation used in reported 12-month follow-up eGFR
Equation used in reported 12-month follow-up eGFR:
2021 CKD-EPI creatinine 2021 CKD-EPI creatinine-cystatin C 2012 CKD-EPI cystatin C MDRD (based on creatinine) Cockroft-Gault (based on creatinine) Schwartz equation (based on creatinine) Not specified
Measured: Month 12 follow-up
Laboratory measurements: Follow-up serum creatinine or eGFR 6 months after baseline
Serum creatinine (preferred) or eGFR at 6 months after baseline
Measured: Up to 12 months
Laboratory measurements: eGFR slope during the 12 months after baseline, mL/min/1.73m²/year
Average eGFR slope computed using available follow-up serum creatinine values (preferred) or eGFR
Measured: Up to 12 months
Laboratory measurements: Change in computed eGFR from baseline to 12-month, mL/min/1.73m
Difference in absolute value of computed eGFR between end of follow-up and baseline
Measured: Baseline, Month 12
Laboratory measurements: Number of participants with Proteinuria 24-hour uPCR
No Yes 24-hour uPCR < 1 g/g 24-hour uPCR ≥ 1 g/g
Measured: Up to 12 months
Laboratory measurements: Number of participants with Proteinuria at 12-month follow-up - spot uPCR
No Yes Spot uPCR < 1 g/g Spot uPCR ≥ 1 g/g
Measured: Up to 12 months
Laboratory measurements: Proteinuria at 12-month, spot uPCR in g/g
Absolute value of uPCR based on a spot urine collection
Measured: Up to 12 months
Laboratory measurements: Proteinuria at 12-month follow-up, 24-hour uPCR in g/g
Absolute value of uPCR based on a 24-hour urine collection
Measured: Up to 12 months
Laboratory measurements: Change in proteinuria from baseline to 12-month follow-up, 24-hour uPCR in g/g
Difference in absolute value of 24-hour uPCR from baseline to 12-month follow-up, in g/g
Measured: Baseline, Month 12
Laboratory measurements: Change in proteinuria from baseline to 12-month follow-up, spot uPCR in g/g
Difference in absolute value of spot uPCR from baseline to 12-month follow-up, in g/g
Measured: Baseline, Month 12
Laboratory measurements: Change in proteinuria from baseline to 12-month follow-up in mg/mmol - 24-hour uPCR
Change of uPCR based on a 24-hour urine collection from baseline to 12-month follow-up, in mg/mmol Below 100 mg/mmol Above 100 mg/mmol
Measured: Baseline, Month 12
Laboratory measurements: Change in proteinuria from baseline to 12-month follow-up in mg/mmol - spot uPCR
Change of uPCR based on a spot urine collection from baseline to 12-month follow-up, in mg/mmol Below 100 mg/mmol Above 100 mg/mmol
Measured: Baseline, Month 12
Laboratory measurements: Change in proteinuria from baseline to 12-month follow-up in g/g - 24-hour uPCR
Change of uPCR based on a 24-hour urine collection from baseline to 12-month follow-up, in mg/mmol Below 1 g/g Above 1 g/g
Measured: Baseline, Month 12
Laboratory measurements: Change in proteinuria from baseline to 12-month follow-up in g/g - spot uPCR
Change of uPCR based on a spot urine collection from baseline to 12-month follow-up, in mg/mmol Below 1 g/g Above 1 g/g
Measured: Baseline, Month 12
Laboratory measurements: Number of participants with albuminuria
No Yes
Measured: Up to 12 months
Laboratory measurements: Number of participants with Albuminuria at 12-month follow-up - spot uACR
No Yes
Measured: Up to 12 months
Laboratory measurements: Albuminuria at 12-month follow-up, 24-hour uACR in g/g
Absolute value of uACR based on a 24-hour urine collection
Measured: Up to 12 months
Laboratory measurements: Albuminuria at 12-month follow-up, spot uACR in g/g
Absolute value of uACR based on a spot urine collection
Measured: Up to 12 months
Laboratory measurements: Change in albuminuria from baseline to 12-month follow-up, 24-hour uACR in g/g
Difference in absolute value of 24-hour uACR from baseline to 12-month follow-up
Measured: Baseline, Month 12
Laboratory measurements: Change in albuminuria from baseline to 12-month follow-up, spot uACR in g/g
Difference in absolute value of spot uACR from baseline to 12-month follow-up
Measured: Baseline, Month 12
Laboratory measurements: Number of participants with Hematuria dipstick
No Yes Microscopic Macroscopic
Measured: Up to 12 months
Laboratory measurements: Hematuria - Number of participants by urinalysis results
0-2 red blood cells
≥3 red blood cells
Measured: Up to 12 months
Laboratory measurements: Hematuria - urinalysis, number of red blood cells
Number of red blood cells detected through urinalysis
Measured: Up to 12 months
Laboratory measurements: Change in hematuria from baseline to 12-month follow-up
No change From no to yes From yes to no
Measured: Baseline, Month 12
Laboratory measurements: Change in hematuria on urinalysis from baseline to 12-month follow-up, number of red blood cells
Difference in absolute number of red blood cells detected through urinalysis from baseline to 12-month follow-up
Measured: Baseline, Month 12
Laboratory measurements: Number of participants with presence of autoantibodies
No Presence of any of the below autoantibodies C3NeF C4NeF C5NeF Anti-factor H autoantibodies Anti-factor B autoantibodies Anti-C3b autoantibodies
Measured: Up to month 12 follow-up
Laboratory measurements: CH50 and CH100
CH50: The 50% activity of the classic pathway of the complement CH100: Total activity of the classic pathway of the complement
Measured: Up to month 12 follow up
Laboratory measurements: AH50 and AH100
AH50: The 50% activity of the alternative pathway of the complement AH100: Total activity of the alternative pathway of the complement
Measured: Up to month 12 follow-up
Laboratory measurements: Wieslab activity of the alternative pathway of complement
Wieslab activity values are provided on a scale such that 100% of activity is normal activity. Full inhibition of alternative pathway corresponds to a value of 0
Measured: Up to month 12 follow-up
Laboratory measurements: Serum C3, Serum C4 and Serum C5
Serum C3 Reference range: LLN = 4.33-5.00 µmol/L ; ULN = 9.05-11.16 µmol/L Serum C4 Reference range: LLN = 0.50-0.70 µmol/L ; ULN = 2.00-2.60 µmol/L Serum C5 Reference range: LLN = 50 µg/mL ; ULN = 115 µg/mL
Measured: Up to month 12 follow-up
Laboratory measurements: Fibrinogen Degradation; (FD)
Reference range:
LLN = 1437 µg/L ULN = 3966 µg/L
Measured: Up to month 12 follow-up
Laboratory measurements: fragment a of complement factor B (Ba)
Reference range:
LLN = 338 ng/mL ULN = 1164 ng/mL
Measured: Up to month 12 follow-up
Laboratory measurements: fragment b of complement factor B (Bb)
Reference range:
LLN = 0.49 mg/L ULN = 1.42 mg/L
Measured: Up to 12 months follow-up
Laboratory measurements: soluble terminal complement activation fragment (sC5b-9)
Reference range: LLN = 95 µg/L ULN = 467 µg/L
Measured: Up to 12 months follow-up
Disease management: Number of participants by status of vaccination and prophylactic antibiotic at baseline
Vaccination status at baseline Neisseria meningitidis Staphylococcus pneumoniae Vaccinated for both Received prophylactic antibiotic treatment
Measured: Up to 12 months follow up
Disease management: Number of participants by Iptacopan daily dose
Iptacopan daily dose at initiation and at the end of follow-up (or at discontinuation)
Measured: Baseline and up to 12 months follow-up
Disease management: Number of participants by Iptacopan daily dose change from baseline to the end of follow-up
Dose increase Dose decrease No modification
Measured: Baseline, up to month 12 follow-up
Disease management: Time to first modification of iptacopan dosage (days)
Time from baseline to the first modification of the daily dose of iptacopan
Measured: Up to 12 months-follow up
Disease management: Number of participants by reason of modification of iptacopan dosage during follow-up
Reason of modification of iptacopan dosage during follow-up
Measured: Up to 12 months follow-up
Disease management: Missed or delayed dose of iptacopan during follow-up
0 1-2 3-4 5 or more
Measured: Up to 12 months follow-up
Disease management: Number of participants with prior use of immunosuppressive medication
Immunosuppressive medication used before baseline and/or discontinued before baseline.
No Yes Corticosteroids Prednisolone Methylprednisolone Cyclophosphamide Complement inhibitors C5 inhibitors (e.g., eculizumab) Other complement inhibitors (specify) Mycophenolate mofetil Rituximab Tacrolimus mTORi (everolimus/sirolimus) Other C3G medication (specify)
Measured: Up to month 12 follow-up
Disease management: Time from C3G diagnosis to the first complement inhibitor before baseline
Concerns only patients with prior use of complement inhibitors.
Measured: Baseline
Disease management: Number of participants by concomitant C3G treatments
Use of other C3G treatment in concomitance to iptacopan. No Yes ACEi/ARB Corticosteroids Prednisolone Methylprednisolone Cyclophosphamide Complement inhibitors C5 inhibitors (e.g., eculizumab) Other complement inhibitors (specify) Mycophenolate mofetil Rituximab SGLT2i Tacrolimus mTORi (everolimus/sirolimus) Other C3G medication (specify)
Measured: Up to 12 months follow-up
Disease management: Duration of C3G treatments during follow-up
Duration of each of the following C3G treatments during the follow-up:
ACEi/ARB Corticosteroids Prednisolone Methylprednisolone Cyclophosphamide Complement inhibitors C5 inhibitors (e.g., eculizumab) Other complement inhibitors (specify) Mycophenolate mofetil Rituximab SGLT2i Tacrolimus mTORi (everolimus/sirolimus) Other C3G medication (specify)
Measured: Up to 12 months follow-up
Disease management: Number of participants by reason of discontinuation of C3G treatments during follow-up
treatments during the follow-up: ACEi/ARB Corticosteroids Prednisolone Methylprednisolone Cyclophosphamide Complement inhibitors C5 inhibitors (e.g., eculizumab) Other complement inhibitors (specify) Mycophenolate mofetil Rituximab SGLT2i Tacrolimus mTORi (everolimus/sirolimus) Other C3G medication (specify)
Measured: Up to 12 months follow-up
Disease management: Number of participants with antibiotic treatment related to C3G during follow- up
Any antibiotic therapy during follow-up No Yes
Measured: Up to 12 months follow-up
Disease management: Adherence to iptacopan treatment - PDC
PDC calculated as the total number of days between iptacopan initiation and treatment discontinuation or death. Patients are censored upon disenrollment or reaching the end of follow-up
Measured: Up to 12 months follow-up
Disease management: Number of participants by adherence to iptacopan treatment
PDC < 80% PDC ≥ 80%
Measured: Up to month 12 follow-up
Disease management: Number of participants with discontinuation of iptacopan during follow-up
Number of participants with discontinuation of iptacopan during follow-up and reason for discontinuation of iptacopan
Measured: Up to 12 months follow-up
Disease management: Time to iptacopan treatment discontinuation - TTD
Time from iptacopan initiation to iptacopan discontinuation or death. Patients are censored upon disenrollment or reaching the end of follow-up
Measured: Up to 12 months follow-up
Disease management: Number of participants with C3G treatment change after iptacopan discontinuation
Reason of discontinuation of each of the following C3G treatments during the follow-up:
ACEi/ARB Corticosteroids Prednisolone Methylprednisolone Cyclophosphamide Complement inhibitors C5 inhibitors (e.g., eculizumab) Other complement inhibitors (specify) Mycophenolate mofetil Rituximab SGLT2i Tacrolimus mTORi (everolimus/sirolimus) Other C3G medication (specify)
Measured: Up to 12 months follow-up
Disease management: Numbre of participants by antibiotic treatment related to C3G during follow-up
Any antibiotic therapy during follow-up No Yes
Measured: Up to 12 months follow up
Disease management: Adherence to iptacopan treatment - PDC, %
PDC calculated as the total number of days between iptacopan initiation and treatment discontinuation or death. Patients are censored upon disenrollment or reaching the end of follow-up
Measured: Up to 12 months follow up
Disease management: Adherence to iptacopan treatment, n (%)
PDC < 80% PDC ≥ 80%
Measured: Up to 12 months follow up
Disease management: Number of participants discontinuing iptacopan during follow-up
Discontinuation of iptacopan, with no resumption during the follow-up period. No Yes
Measured: Up to 12 months follow up
Disease management: Number of participants by reason for discontinuation of iptacopan, n (%)
Concerning only patients with iptacopan discontinuation during follow-up. Infection Other adverse effects Death Loss to follow-up Other reasons (to be potentially defined during analysis)
Measured: Up to 12 months follow up
Disease management: Time to iptacopan treatment discontinuation - TTD, days
Time from iptacopan initiation to iptacopan discontinuation or death. Patients are censored upon disenrollment or reaching the end of follow-up
Measured: Up to 12 months follow up
Disease management: C3G treatment change after iptacopan discontinuation, n (%)
Concerning only patients with iptacopan discontinuation during follow-up. No Yes ACEi/ARB Corticosteroids Prednisolone Methylprednisolone Cyclophosphamide Complement inhibitors C5 inhibitors (e.g., eculizumab) Other complement inhibitors (specify) Mycophenolate mofetil Rituximab SGLT2i Tacrolimus mTORi (everolimus/sirolimus) Other C3G medication (specify)
Measured: Up to 12 months follow up
Healthcare resource utilization: Number of hospitalizations during the 12-month period before baseline
Number of hospitalizations, for any cause, during the 12- month period before baseline
Measured: Baseline
Healthcare resource utilization: Number of participants by cause of first hospitalization during the 12-month period before baseline
Concerns only patients with 1 or more hospitalizations during the 12-month period before baseline.
Measured: Baseline
Healthcare resource utilization: Length of first hospitalization during the 12-month period before baseline
Concerns only patients with 1 or more hospitalizations during the 12-month period before baseline
Measured: Baseline
Healthcare resource utilization: Number of participants bu cause of first readmission after first hospitalization during the 12-month period before baseline
Concerning only patients with 2 or more hospitalizations during the 12-month period before baseline
Measured: Baseline
Healthcare resource utilization: Length of first readmission after first hospitalization during the 12-month period before baseline
Concerns only patients with 2 or more hospitalizations during the 12-month period before baseline
Measured: Baseline
Healthcare resource utilization: Number of hospitalizations due to infection during the 12-month period before baseline
Number of hospitalizations due to infection during the 12-month period before baseline by Type (incl. pathogen) of infections
Measured: Baseline
Healthcare resource utilization: Number of hospitalizations during follow-up
Number of hospitalizations, for any cause, from baseline to 12-month follow-up
Measured: Up to 12 months follow-up
Healthcare resource utilization: Number of participants by cause of first hospitalization during follow-up
Concerns only patients with 1 or more hospitalizations during the follow-up period.
Categories to be defined at the analysis stage.
Measured: Up to 12 months follow-up
Healthcare resource utilization: Length of first hospitalization during follow-up
Concerns only patients with 1 or more hospitalizations during the follow-up period
Measured: Up to 12 months follow-up
Healthcare resource utilization: Number of participants by cause of first readmission after first hospitalization during follow-up
Concerning only patients with 2 or more hospitalizations during the follow-up period.
Categories to be defined at the analysis stage.
Measured: Up to 12 months follow-up
Healthcare resource utilization: Length of first readmission after first hospitalization during follow-up
Concerning only patients with 2 or more hospitalizations during the follow-up period
Measured: Up to 12 months follow-up
Healthcare resource utilization: Number of hospitalizations due to infection during follow-up
Number of hospitalizations due to infection during follow-up and Type (incl. pathogen) of infections
Measured: Up to 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C3 GlomerulopathyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331259
- Sponsor's protocol ID
- CLNP023B12011
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C3 Glomerulopathy Patient Characteristics and Treatment Response to Iptacopan in Routine Care: Analysis of Medical Charts (CHART-C3G)
- ClinicalTrials.gov ID
- NCT07331259
- Acronym / sponsor ID
- CLNP023B12011
- Keywords
- NIS-PDC, Germany, C3G, Iptacopan, estimated Glomerular Filtration Rate
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-interventional chart abstraction cohort study with longitudinal follow up. Patients with C3G treated with iptacopan will be enrolled and characterized (i.e., systematically describe and summarize) regarding their medical history and iptacopan use and evaluated for clinical events, outcomes, and laboratory measurements upon and after iptacopan treatment initiation. Medical charts will be used to obtain secondary pseudonymized patient-level data with reference to 2 time anchors: at index date (date of iptacopan treatment initiation) with baseline covering 12 months prior to index date, and at 12-month follow-up (twelve months after the index date).The observation period includes baseline plus follow-up.
Iptacopan will be used as prescribed by the clinician in accordance with the terms of the marketing authorization. This Novartis-sponsored study, mainly executed by a contract research organization (CRO), will use secondary data from EHR obtained through reference centers/ centers of excellence in glomerular diseases in Germany.
The primary objective of this study is to characterize the demographic and clinical profiles of adult patients diagnosed with C3G upon iptacopan treatment initiation.
Detailed description
Until recently, there are no approved disease-specific treatments for C3G, although there is significant interest in the therapeutic potential of complement inhibition.
Iptacopan, the first oral effective targeted disease-modifying proximal complement inhibitor developed by Novartis, has been approved in April 2025 for the treatment of adults with C3G.
The primary objective of this study is to characterize the demographic and clinical profiles of adult patients diagnosed with C3G upon iptacopan treatment initiation.
By analyzing key endpoints such as age, sex, ethnicity, BMI, clinical symptoms, proteinuria, blood pressure, serum creatinine, eGFR, serum C3 levels, and renal histological parameters, we aim to better understand disease progression and treatment outcomes.
Additionally, we will assess CKD stages, history of kidney failure, dialysis status, transplant status, and comorbidities to identify the characteristics of patients treated with iptacopan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iptacopan | – | Other: IptacopanAdult patients with C3G initiating iptacopan treatment in routine care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥18 years clinically diagnosed with C3G from participating study sites who initiate iptacopan during the period between 31-Mar-2025 and 31-Dec-2025
Key inclusion criteria (4 listed)
- Clinical diagnosis of C3G (confirmed by biopsy, only if available)
- Aged ≥18 years at time of index date.
- At least 6 months of baseline period preceding index date.
- Users of iptacopan treatment including those who have discontinued iptacopan within the last twelve weeks.
Key exclusion criteria (1 listed)
- Interventional C3G clinical trial participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IptacopanAlso: LNP023BThere is no treatment allocation for NIS trials. Patients administered Iptacopan by prescription will be enrolled. | Other | Iptacopan |
Primary outcome
Demographics: Number of patients by age
Time frame: Baseline
Age at baseline in years
Demographics: Number of patients by sex
Time frame: Baseline
Female Male
Demographics: Number of patients by site
Time frame: Baseline
Academic hospital Other sites
Demographics: Body mass index
Time frame: Baseline
Body mass index reported at baseline, or the closest value before baseline. In the absence of records for body mass index, it can be calculated using records of height and weight.
Demographics: Number of patinets with Biopsy confirming C3G
Time frame: Baseline
No Yes
Clinical symptoms: Proteinuria - Number of participants by 24-hour uPCR
Time frame: Baseline
No Yes 24-hour uPCR < 1 g/g 24-hour uPCR ≥ 1 g/g
Proteinuria - Number of participants by spot uPCR
Time frame: Baseline
No Yes Spot uPCR < 1 g/g Spot uPCR ≥ 1 g/g
Proteinuria, 24-hour uPCR in g/g
Time frame: Baseline
Absolute value of uPCR based on a 24-hour urine collection
Proteinuria, spot uPCR in g/g
Time frame: Baseline
Absolute value of uPCR based on a spot urine collection
Clinical symptoms: Albuminuria
Time frame: Baseline
No Yes
Albuminuria - Number of participants by spot uACR
Time frame: Baseline
No Yes
Albuminuria, 24-hour uACR in g/g
Time frame: Baseline
Absolute value of uACR based on a 24-hour urine collection
Albuminuria, spot uACR in g/g
Time frame: Baseline
No Yes
Clinical symptoms: Number of participants by Hematuria - dipstick results
Time frame: Baseline
No Yes Microscopic (≥3RBCs/HPF) Macroscopic (visible to the naked eye)
Hematuria - Number of participants by urinalysis results
Time frame: Baseline
0-2 red blood cells ≥3 red blood cells
Hematuria - urinalysis, number of red blood cells
Time frame: Baseline
Number of red blood cells detected through urinalysis
Clinical symptoms: Number of participants with presence of edema
Time frame: Baseline
Presence of edema. No Yes
Clinical symptoms: Systolic and diastolic blood pressure
Time frame: Baseline
Blood pressure measurement
Clinical symptoms: Number of participants with hypertension
Time frame: Baseline
Defined as systolic blood pressure ≥140 mmHg or a diastolic blood pressure ≥90 mmHg No Yes
Clinical symptoms: Serum creatinine at baseline
Time frame: Baseline
Absolute value of serum creatinine
Clinical symptoms: Reported eGFR at baseline
Time frame: Baseline
Based on medical records of eGFR
Clinical symptoms: Number of participants by equation used in reported eGFR at baseline
Time frame: Baseline
2021 CKD-EPI creatinine 2021 CKD-EPI creatinine-cystatin C 2012 CKD-EPI cystatin C 2012 CKD-EPI creatinine-cystatin C 2009 CKD-EPI creatinine MDRD (based on creatinine) Cockroft-Gault (based on creatinine) Schwartz equation (based on creatinine) Not specified
Clinical symptoms: Computed eGFR at baseline
Time frame: Baseline
eGFR computed in the study analysis
Clinical symptoms: Serum C3 at baseline
Time frame: Baseline
Reference range: LLN = 4.33-5.00 μmol/L ULN = 9.05-11.16 μmol/L
Clinical events and outcomes: Time since C3G diagnosis (days/months)
Time frame: Baseline
Time since the first C3G diagnosis to baseline
Clinical events and outcomes: Number of participants with Chronic Kidney Disease (CKD) and stage
Time frame: Baseline
No Yes Stage 1 Stage 2 Stage 3 Stage 4 Stage 5
Clinical events and outcomes: Number of participants with history of kidney failure
Time frame: Baseline
No Yes (either of the categories below) eGFR ≤ 15 History of dialysis History of kidney transplant
Clinical events and outcomes: Number of participants by dialysis status
Time frame: Baseline
No Yes Dialysis at diagnosis of C3G Maintenance dialysis Other types
Clinical events and outcomes: Time from C3G diagnosis to dialysis (months)
Time frame: Baseline
Concerns only patients with dialysis at or before baseline
Clinical events and outcomes: Time from dialysis to baseline (months)
Time frame: Baseline
Concerns only patients with dialysis at or before baseline
Clinical events and outcomes: Number of participants by transplant status at baseline
Time frame: Baseline
No (native kidney) Yes Biopsy-confirmed disease in native kidney No evidence of disease recurrence Recurrent disease in transplanted kidney
Clinical events and outcomes: Time from C3G diagnosis to kidney transplant before baseline (months)
Time frame: Baseline
Concerns only patients with a kidney transplant (or kidney transplant failure) at or before baseline
Clinical events and outcomes: Time from kidney transplant before baseline to baseline (months)
Time frame: Baseline
Concerns only patients with a kidney transplant (or kidney transplant failure) at or before baseline
Clinical events and outcomes: Number of participants with C3G disease recurrence post-transplant and/or transplant failure
Time frame: Baseline
Concerns only patients with a kidney transplant (or kidney transplant failure) at or before baseline. No Yes
Clinical events and outcomes: Number of participants with comorbidities
Time frame: Baseline
For example, history of heart failure, history of stroke, diabetes mellitus, dementia, malignancy
Renal histopathological parameters: Number of participants with presence of cysts
Time frame: Baseline
No Yes
Renal histopathological parameters: Number of participants with presence of tumors
Time frame: Baseline
No Yes
Renal histopathological parameters: Number of participants with presence of interstitial fibrosis or tubular atrophy
Time frame: Baseline
Mild Moderate Severe
Renal histopathological parameters: Number of participants with presence of glomerulosclerosis
Time frame: Baseline
Mild Moderate Severe
Renal histopathological parameters: Endocapillary hypercellularity
Time frame: Baseline
Presence of cells in capillary loops with loop occlusion 0 = 0% (Essentially normal or no lesion) 1. = 1-25% (Only a small fraction of loops are occluded by hypercellularity) 2. = 26-50% (About one-quarter to half of the loops show occlusion) 3. = ≥51% (More than half of the loops are occluded, indicating extensive endocapillary proliferation)
Renal histopathological parameters: Neutrophils in capillary lumens (each glomerulus is scored)
Time frame: Baseline
0 = 0% (No neutrophils in any capillary loops of the glomerulus) 1. = 1-25% (Mild involvement: neutrophils present in up to ¼ of loops) 2. = 26-50% (Moderate involvement: neutrophils in about ¼ to half of loops) 3. = ≥51% (Severe involvement: neutrophils in more than half of loops)
Renal histopathological parameters: Mesangial hypercellularity
Time frame: Baseline
More than 4 cells in a mesangial area away from the hilum 0 = 0% (No mesangial areas with >4 cells) 1. = 1-25% (Mild involvement: 1-25% of mesangial areas show hypercellularity) 2. = 26-50% (Moderate involvement: 26-50% of mesangial areas affected) 3. = ≥51% (Severe involvement: More than half of mesangial areas show hypercellularity)
Renal histopathological parameters: Necrosis
Time frame: Baseline
Necrosis in glomerular pathology refers to active destructive lesions characterized by: Disruption of the glomerular basement membrane (GBM) Fibrin exudation into Bowman's space or capillary loops Karyorrhexis (fragmentation of nuclei of inflammatory cells) - at least 2 of these 3 lesions need to be present to meet the criteria for necrosis. 0 = 0% (No glomeruli show necrosis) 1. = 1-10% (Mild: 1-10% of glomeruli have necrosis) 2. = 11-25% (Moderate: 11-25% of glomeruli affected) 3. = ≥25% (Severe: More than 25% of glomeruli show necrosis)
Renal histopathological parameters: Cellular or fibrocellular crescents
Time frame: Baseline
0 = 0% (No crescents in any glomeruli) 1. = 1-10% (Mild: 1-10% of glomeruli have crescents) 2. = 11-25% (Moderate: 11-25% of glomeruli affected) 3. = >25% (Severe: More than 25% of glomeruli show crescents)
Renal histopathological parameters: Activity index
Time frame: Baseline
A score between 0 and 15, calculated by summing up the scores from the activity index parameters above (Endocapillary hypercellularity,. Neutrophils in capillary lumens, Mesangial hypercellularity, Necrosis and Cellular or fibrocellular crescents). Score 0: No active lesions. The kidney shows chronic changes only, but no ongoing inflammation. Higher score implies not aggressively active, and kidney damage is likely stable or progressing slowly.
Renal histopathological parameters: score inflammation assessment scale
Time frame: Baseline
Both continuous (score inflammation assessment scale) and categorically (none, mild, moderate, severe). Continuous Scale (Numeric Score) 1. Low score (e.g., 0-3) Minimal inflammatory activity 2. High score (e.g., ≥9) Extensive active lesions (necrosis, crescents, heavy infiltration) Categorical Scale (None, Mild, Moderate, Severe) 1. None: No significant inflammation; likely chronic or inactive disease. 2. Mild: Small, focal involvement; early or controlled disease. 3. Moderate: Widespread but not diffuse; active disease needing treatment. 4. Severe: Diffuse, aggressive inflammation; high risk of rapid progression to renal failure.
Renal histopathological parameters: Number of participants by typo of inflammation
Time frame: Baseline
Type of inflammation: none, mild, moderate, severe
Chronicity index parameters: Number of participants with glomerular (or segmental) sclerosis
Time frame: Baseline
0 = ≤10% 1. = 11-25% 2. = 26-50% 3. = ≥51%
Chronicity index parameters: Number of participants with Fibrous crescents
Time frame: Baseline
0 = none 1. = ≤25% 2. = 26-50% 3= >51%
Chronicity index parameters: Number of participants with tubular atrophy
Time frame: Baseline
0 = ≤5% 1. = 6-25% 2. = 26-50% 3. = ≥51%
Chronicity index parameters: Number of participants with interstitial fibrosis
Time frame: Baseline
0 = ≤5% 1. = 6-25% 2. = 26-50% 3. = ≥51%
Renal histopathological parameters: Chronicity index
Time frame: Baseline
A score between 0 and 12, calculated by summing up the scores from the chronicity index parameters above (Glomerular (or segmental) sclerosis, Fibrous crescents, Tubular atrophy and Interstitial fibrosis) Lower scores indicate less chronic damage, higher scores indicate more scarring and poor prognosis. 0-3 (Minimal to Mild) → Very little irreversible damage. Prognosis is generally favorable if activity index is also low. 4-6 (Moderate) * Significant chronic changes; recovery potential is limited. 7-12 (Severe) * Extensive scarring; immunosuppression unlikely to reverse damage
96 secondary outcomes
Clinical events and outcomes: Number of participants with kindney failure during follow-up
Time frame: Up to 12 months
Clinical events and outcomes: Time from C3G diagnosis to kidney failure and time from baseline to kidney failure
Time frame: Up to 12 months
Clinical events and outcomes: Number of participants with dialysis during follow-up
Time frame: Up to 12 months
Clinical events and outcomes:Time from kidney failure to first dialysis (months)
Time frame: Up to 12 months
Clinical events and outcomes: Time from baseline to first dialysis (months)
Time frame: Up to 12 months
Clinical events and outcomes: Time from kidney failure to maintenance dialysis (months)
Time frame: Up to 12 months
Clinical events and outcomes: Time from C3G diagnosis to maintenance dialysis (months)
Time frame: Up to 12 months
Clinical events and outcomes: Time from baseline to maintenance dialysis (months)
Time frame: Up to 12 months
Clinical events and outcomes: Number of participants with complete remission (controlled) of C3G during follow-up
Time frame: Up to 12 months
Clinical events and outcomes: Number of participants with nephrotic-range and non-nephrotic range proteinuria during follow-up
Time frame: Up to 12 months
Clinical events and outcomes: Number of participants with renal relapse, progression to a higher CKD stage, or chronic renal replacement therapy during follow-up
Time frame: Up to 12 months
Clinical events and outcomes: Number of transplant failures per patient during follow-up
Time frame: Up to 12 months
Clinical events and outcomes: Number of participants with CKD and stage at 12-month follow-up
Time frame: Up to 12 months
Clinical events and outcomes: Number of participants by transplant status at 12-month follow-up
Time frame: Up to 12 months
Clinical events and outcomes: Number of participants with Kidney transplant during follow-up
Time frame: Up to 12 months
Clinical events and outcomes: Time from kidney failure to transplant during follow-up (months)
Time frame: Up to 12 months
Clinical events and outcomes: Time from transplant during follow-up to post- transplant C3G disease recurrence (months)
Time frame: Up to 12 months
Clinical events and outcomes: Time from transplant to transplant failure (months)
Time frame: Up to 12 months
Clinical events and outcomes: Number of participants with C3G disease recurrence post-transplant and/or transplant failure
Time frame: Up to 12 months
Clinical events and outcomes: Time from C3G disease recurrence to transplant failure
Time frame: Up to 12 months
Clinical events and outcomes: Time from transplant at any time to post- transplant C3G disease recurrence
Time frame: Up to 12 months
Clinical events and outcomes: Number of participants with death during follow-up
Time frame: Up to 12 months
Clinical events and outcomes: Number of participants by cause of Death
Time frame: Up to 12 Months
Laboratory measurements: Serum creatinine or eGFR
Time frame: 6 months, 12 months and 24 months before baseline and up to 12 months follow-up
Laboratory measurements: eGFR slope during the 24months prior to baseline
Time frame: 24 months prior to baseline and 12 months post baseline
Laboratory measurements: Change in reported eGFR from baseline to 12-month follow-up, mL/min/1.73m
Time frame: Baseline, Month 12
Laboratory measurements: Equation used in reported 12-month follow-up eGFR
Time frame: Month 12 follow-up
Laboratory measurements: Follow-up serum creatinine or eGFR 6 months after baseline
Time frame: Up to 12 months
Laboratory measurements: eGFR slope during the 12 months after baseline, mL/min/1.73m²/year
Time frame: Up to 12 months
Laboratory measurements: Change in computed eGFR from baseline to 12-month, mL/min/1.73m
Time frame: Baseline, Month 12
Laboratory measurements: Number of participants with Proteinuria 24-hour uPCR
Time frame: Up to 12 months
Laboratory measurements: Number of participants with Proteinuria at 12-month follow-up - spot uPCR
Time frame: Up to 12 months
Laboratory measurements: Proteinuria at 12-month, spot uPCR in g/g
Time frame: Up to 12 months
Laboratory measurements: Proteinuria at 12-month follow-up, 24-hour uPCR in g/g
Time frame: Up to 12 months
Laboratory measurements: Change in proteinuria from baseline to 12-month follow-up, 24-hour uPCR in g/g
Time frame: Baseline, Month 12
Laboratory measurements: Change in proteinuria from baseline to 12-month follow-up, spot uPCR in g/g
Time frame: Baseline, Month 12
Laboratory measurements: Change in proteinuria from baseline to 12-month follow-up in mg/mmol - 24-hour uPCR
Time frame: Baseline, Month 12
Laboratory measurements: Change in proteinuria from baseline to 12-month follow-up in mg/mmol - spot uPCR
Time frame: Baseline, Month 12
Laboratory measurements: Change in proteinuria from baseline to 12-month follow-up in g/g - 24-hour uPCR
Time frame: Baseline, Month 12
Laboratory measurements: Change in proteinuria from baseline to 12-month follow-up in g/g - spot uPCR
Time frame: Baseline, Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
An observational study of C3 Glomerulopathy and Complement-mediated Kidney Disease, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics: Number of patients by age (time frame: Baseline). The study lists 52 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.