IgA NephropathyNCT07481084
IgA Nephropathy Insights From Treatment Experience Among Patients Receiving Iptacopan and/or Atrasentan Using Primary Data Collection
An observational study of IgA Nephropathy, run by Novartis Pharmaceuticals.
Trial summary
The current prospective, non-interventional study (NIS) being conducted under the IgNITE umbrella protocol using primary data collection (PDC), aims to enhance understanding of real-world patient profiles, treatment patterns, and clinical outcomes among patients with IgAN treated with iptacopan or atrasentan in the… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- IgA Nephropathy
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 29 May 2026to 30 Mar 2029
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with IgAN (≥18 years) to be treated with iptacopan or atrasentan in the real-world setting
Who may be able to join
- Biopsy confirmed diagnosis of IgAN.
- Age ≥18 years at index date.
- Eligible for treatment with iptacopan or atrasentan as per approved drug label and local regulations at the discretion of treating physician.
- Able to provide written consent for participation. a. Patients who withdraw their consent will be censored on this date; all aggregated and anonymised data collected up to that date will be included in a centralised IgNITE data platform.
Who cannot join
- Use of investigational drugs during the study, OR within 3 months before index date, OR within 5 half-lives of investigational drug before index date, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
- Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored study (NIS or interventional) with iptacopan/atrasentan.
- Known hypersensitivity or contraindications to iptacopan, atrasentan, or their excipients, as documented in the patient's medical records.
- Presence of significant comorbidities or conditions that may impact the interpretation of the study results or the patient's ability to participate in the study at the discretion of treating physician.
- Pregnancy or other contraindications for iptacopan and/or atrasentan
- Insufficient medical records available for the baseline and follow-up periods.
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: China IgNITE - Umbrella Protocol: IgA Nephropathy Insights From Treatment Experience Among Patients Receiving Iptacopan and/or Atrasentan Using Primary Data Collection
The current prospective, non-interventional study (NIS) being conducted under the IgNITE umbrella protocol using primary data collection (PDC), aims to enhance understanding of real-world patient profiles, treatment patterns, and clinical outcomes among patients with IgAN treated with iptacopan or atrasentan in the real-world clinical care setting immediately from the time of drug launch. Furthermore, this study is planned to contribute to a global meta-analysis, to enable further analysis with greater statistical power, as well as exploration of similarities and differences of treatment use and outcomes between countries and regions. Each patient will be observed for 24 months
- Conditions
- IgA Nephropathy
- Keywords
- China IgNITE, Iptacopan, atrasentan
- Medical subject headings
- Glomerulonephritis, IGA
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline demographic
Age and sex
Measured: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Time of IgAN diagnosis
Time of IgAN diagnosis and biopsy that's related with the IgAN dianosis
Measured: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Baseline MEST-C
Scored according to the Oxford classification MEST-C criteria:
- Mesangial hypercellularity (M0/M1)
- Endocapillary hypercellularity (E0/E1)
- Segmental glomerulo- sclerosis (S0/S1)
- Tubular atrophy/interstitial fibrosis (T0/T1/T2)
- Crescents (C0/C1/C2)
Measured: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Index Blood Pressure
Measured: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Index eGFR
Measured: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Index proteinuria
Measured: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Index hematuria
Measured: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Index serum albumin level
Measured: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Index creatinine level
Measured: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Number of participants by Index CKD stage
CKD stages:
- Stage 1: Normal or minimal kidney damage with normal GFR (eGFR ≥90 mL/min/1.73m2)
- Stage 2: Mild decrease in GFR (eGFR 60-89 mL/min/1.73m2)
- Stage 3a: Mild to moderate decrease in GFR (eGFR 45-59 mL/min/1.73m2)
- Stage 3b: Moderate to severe decrease in GFR (eGFR 30-44 mL/min/1.73m2)
- Stage 4: Severe decrease in GFR (eGFR 15-29 mL/min/1.73m2)
- Stage 5: Kidney failure (eGFR <15 mL/min/1.73m2)
Measured: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Number of participants by ESKD status
ESKD status is a binary variable, meaning with or without ESKD
Measured: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: History of dialysis and kidney transplant
Number of participants with history of dialysis and kidney transplant
Measured: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Baseline use of corticosteroids or targeted Budesonide for IgAN
Measured: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Baseline use of ACEi, ARB and SGLT2i treatments
Measured: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Baseline use of ERA, APRIL / APRIL-BAFF therapies, MMF, Hydroxychloroquine, nsMRA , Immunosuppressant
Baseline use of Endothelin Receptor Antagonist (ERA), A Proliferation Inducing Ligand (APRIL) / A Proliferation Inducing Ligand-B-cell Activating Factor (APRIL-BAFF) therapies, MMF, Hydroxychloroquine, nsMRA (Finerenone), Immunosuppressant
Measured: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Number of participants who have participated in a clinical trial
Measured: Index date (date of iptacopan or atrasentan initiation)
Secondary outcomes (9)
Number of participants by treatment sequence during baseline and follow-up period
Treatment sequence refers to longitudinal sequence of lines of treatment received across the study period. The date of treatment initiation and discontinuation will be recorded to determine the number of participants by sequence of treatment.
Measured: up to 24-months
Proteinuria
Measured: Up to 24-months
Proteinuria control rate
Proteinuria control rate (below 0.5g/day or 0.3g/day)
Measured: Up to 24-months
eGFR
Measured: Up to 24-months
Time from index date to complete remission
complete remission defined as 24h proteinuria <0.3 g/d at various time intervals, depending on data availability (i.e. 6, 12, 18 and 24 months, etc.) until the date of treatment discontinuation (iptacopan or atrasentan), death, or loss to follow-up, whichever occurs first.
Measured: Up to 24-months
Change in Chronic Kidney Disease (CKD) stage
Measured: Up to 24-months
Number of patients progressing to kidney failure
Measured: Up to 24-months
Number of patients receiving dialysis
Measured: Up to 24-months
Number of patients progressing to of kidney transplantation
Measured: Up to 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start29 May 2026 (estimated)
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies 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
- 80 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
- NCT07481084
- Sponsor's protocol ID
- CLNP023ACN01
- Status last verified
- Mar 2026
- First submitted
- 5 Feb 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China IgNITE - Umbrella Protocol: IgA Nephropathy Insights From Treatment Experience Among Patients Receiving Iptacopan and/or Atrasentan Using Primary Data Collection
- ClinicalTrials.gov ID
- NCT07481084
- Acronym / sponsor ID
- CLNP023ACN01
- Conditions
- IgA Nephropathy
- Keywords
- China IgNITE, Iptacopan, atrasentan
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 May 2026 (estimated)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 18 Mar 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.
The current prospective, non-interventional study (NIS) being conducted under the IgNITE umbrella protocol using primary data collection (PDC), aims to enhance understanding of real-world patient profiles, treatment patterns, and clinical outcomes among patients with IgAN treated with iptacopan or atrasentan in the real-world clinical care setting immediately from the time of drug launch. Furthermore, this study is planned to contribute to a global meta-analysis, to enable further analysis with greater statistical power, as well as exploration of similarities and differences of treatment use and outcomes between countries and regions. Each patient will be observed for 24 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with IgAN (≥18 years) to be treated with iptacopan or atrasentan in the real-world setting
Key inclusion criteria (4 listed)
- Biopsy confirmed diagnosis of IgAN.
- Age ≥18 years at index date.
- Eligible for treatment with iptacopan or atrasentan as per approved drug label and local regulations at the discretion of treating physician.
- Able to provide written consent for participation. a. Patients who withdraw their consent will be censored on this date; all aggregated and anonymised data collected up to that date will be included in a centralised IgNITE data platform.
Key exclusion criteria (6 listed)
- Use of investigational drugs during the study, OR within 3 months before index date, OR within 5 half-lives of investigational drug before index date, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
- Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored study (NIS or interventional) with iptacopan/atrasentan.
- Known hypersensitivity or contraindications to iptacopan, atrasentan, or their excipients, as documented in the patient's medical records.
- Presence of significant comorbidities or conditions that may impact the interpretation of the study results or the patient's ability to participate in the study at the discretion of treating physician.
- Pregnancy or other contraindications for iptacopan and/or atrasentan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baseline demographic
Time frame: Index date (date of iptacopan or atrasentan initiation)
Age and sex
Baseline clinical characteristics: Time of IgAN diagnosis
Time frame: Index date (date of iptacopan or atrasentan initiation)
Time of IgAN diagnosis and biopsy that's related with the IgAN dianosis
Baseline clinical characteristics: Baseline MEST-C
Time frame: Index date (date of iptacopan or atrasentan initiation)
Scored according to the Oxford classification MEST-C criteria: * Mesangial hypercellularity (M0/M1) * Endocapillary hypercellularity (E0/E1) * Segmental glomerulo- sclerosis (S0/S1) * Tubular atrophy/interstitial fibrosis (T0/T1/T2) * Crescents (C0/C1/C2)
Baseline clinical characteristics: Index Blood Pressure
Time frame: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Index eGFR
Time frame: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Index proteinuria
Time frame: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Index hematuria
Time frame: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Index serum albumin level
Time frame: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Index creatinine level
Time frame: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Number of participants by Index CKD stage
Time frame: Index date (date of iptacopan or atrasentan initiation)
CKD stages: * Stage 1: Normal or minimal kidney damage with normal GFR (eGFR ≥90 mL/min/1.73m2) * Stage 2: Mild decrease in GFR (eGFR 60-89 mL/min/1.73m2) * Stage 3a: Mild to moderate decrease in GFR (eGFR 45-59 mL/min/1.73m2) * Stage 3b: Moderate to severe decrease in GFR (eGFR 30-44 mL/min/1.73m2) * Stage 4: Severe decrease in GFR (eGFR 15-29 mL/min/1.73m2) * Stage 5: Kidney failure (eGFR <15 mL/min/1.73m2)
Baseline clinical characteristics: Number of participants by ESKD status
Time frame: Index date (date of iptacopan or atrasentan initiation)
ESKD status is a binary variable, meaning with or without ESKD
Baseline clinical characteristics: History of dialysis and kidney transplant
Time frame: Index date (date of iptacopan or atrasentan initiation)
Number of participants with history of dialysis and kidney transplant
Baseline clinical characteristics: Baseline use of corticosteroids or targeted Budesonide for IgAN
Time frame: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Baseline use of ACEi, ARB and SGLT2i treatments
Time frame: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Baseline use of ERA, APRIL / APRIL-BAFF therapies, MMF, Hydroxychloroquine, nsMRA , Immunosuppressant
Time frame: Index date (date of iptacopan or atrasentan initiation)
Baseline use of Endothelin Receptor Antagonist (ERA), A Proliferation Inducing Ligand (APRIL) / A Proliferation Inducing Ligand-B-cell Activating Factor (APRIL-BAFF) therapies, MMF, Hydroxychloroquine, nsMRA (Finerenone), Immunosuppressant
Baseline clinical characteristics: Number of participants who have participated in a clinical trial
Time frame: Index date (date of iptacopan or atrasentan initiation)
9 secondary outcomes
Number of participants by treatment sequence during baseline and follow-up period
Time frame: up to 24-months
Proteinuria
Time frame: Up to 24-months
Proteinuria control rate
Time frame: Up to 24-months
eGFR
Time frame: Up to 24-months
Time from index date to complete remission
Time frame: Up to 24-months
Change in Chronic Kidney Disease (CKD) stage
Time frame: Up to 24-months
Number of patients progressing to kidney failure
Time frame: Up to 24-months
Number of patients receiving dialysis
Time frame: Up to 24-months
Number of patients progressing to of kidney transplantation
Time frame: Up to 24-months
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 18 Mar 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 IgA Nephropathy, 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 6 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 18 Mar 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?
Baseline demographic (time frame: Index date (date of iptacopan or atrasentan initiation)). The study lists 16 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 18 Mar 2026.