Primary Immunoglobulin A Nephropathy (IgAN)Phase 3NCT06994845
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients With Primary IgAN
A Phase 3 study testing iptacopan in people with Primary Immunoglobulin A Nephropathy (IgAN), run by Novartis Pharmaceuticals at 20 sites in 8 countries.
Trial summary
The study is an open-label, single arm, multicenter, Phase III study to determine proteinuria reduction, pharmacokinetics (PK), safety and tolerability (including CV surveillance) of iptacopan in primary immunoglobulin A nephropathy (IgAN) pediatric patients aged 2 to <18 years. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Primary Immunoglobulin A Nephropathy (IgAN)
- What is being tested?
- iptacopan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 20 sitesin 8 countries
- Study dates
- 27 Nov 2025to 30 Jun 2030
- Phase
- Phase 3
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female participants 2 to < 18 years of age as of Day 1.
- eGFR ≥ 30 mL/min/1.73m2 where eGFR is calculated using the modified Schwartz formula at Screening and confirmed during the Run-in Period.
- Kidney biopsy-proven primary IgAN*, with biopsy performed within 3 years of Screening with < 50% tubulointerstitial fibrosis and < 25% crescents. In case a kidney biopsy within 3 years from Screening is not available, a kidney biopsy may be performed if it is part of the planned diagnostic approach and clinical management of the participant.
- Note: Primary IgAN is defined as any IgAN that is proven by biopsy showing IgA deposits prevalent over the other classes of immunoglobulins and deemed not to be associated with causes of secondary IgAN as per clinical judgment of the Investigator.
- The minimum body weight for participants in Cohort 1 is 35 kg at Screening and confirmed at Baseline (Day 1).
- Proteinuria due to primary diagnosis of IgAN as assessed by UPCR ≥ 1 g/g (113 mg/mmoL) sampled from FMV at Screening on Day -90 and Day -60 as well as during the Run-in Period despite treatment with maximum tolerated dose of ACE inhibitor/ARB for at least 120 days prior to Day 1. Note: UPCR will be assessed based on one FMV sample at Day -90 and based on the geometric mean of 2 FMV samples for the Day -60 visit and during the Run-in Period.
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- Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection is required prior to the start of study treatment. If the participant has not been previously vaccinated, or if a booster is required, vaccine should be given according to local guidelines at least 2 weeks prior to first study drug administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated.
- Vaccination against Haemophilus influenzae is recommended, according to local guidelines, at least 2 weeks before iptacopan.
- All participants must have been on supportive care including stable dose regimen of ACE inhibitor or ARB at either the locally approved maximal daily dose per body weight, or the maximally tolerated dose (per Investigator's judgment for pediatric use), for at least 120 days before first study drug administration. In addition, if participants are taking diuretics, other antihypertensive medication, or other background medication for IgAN (such as SGLT2 inhibitors), the doses should also be stabilized for at least 120 days prior to the first dosing of study treatment.
Who cannot join
- Any secondary IgAN observed at Screening (and confirmed at Baseline/Day 1) as defined by the Investigator; secondary IgAN can be associated with cirrhosis, celiac disease, human immunodeficiency virus (HIV) infection, herpes simplex virus infection, dermatitis herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, inflammatory bowel disease, and familial mediterranean fever.
- A clinical diagnosis of immunoglobulin A vasculitis (IgAV or Henoch-Schonlein purpura) based on typical palpable purpura with or without arthralgia and abdominal pain.
- Evidence of significant urinary obstruction or difficulty in voiding at Screening (and confirmed at Baseline/Day 1); any urinary tract disorder or any chronic kidney disease other than IgAN at Screening and before first study drug administration.
- Current acute kidney injury (AKI) defined by Acute Kidney Injury Network (AKIN) criteria within 4 weeks of screening.
- Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to Screening or during the Screening and Run-in periods.
- Presence of nephrotic syndrome at Screening based on the investigator's judgment.
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- History or current diagnosis of ECG abnormalities indicating significant risk for study participants such clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, or clinically significant second- or third-degree atrioventricular (AV) block without a pacemaker.
- History or current diagnosis of clinically significant echocardiogram abnormalities indicating significant risk for study participants including but not limited to clinically significant functional, morphological and/or structural abnormalities, which may include left ventricular ejection fraction < 50% and/or left ventricular hypertrophy due to uncontrolled blood pressure at Screening.
- Participants of 12 to < 18 years of age with systolic blood pressure (SBP) < 80 mmHg or > 150 mmHg, or diastolic blood pressure (DBP) < 50 mmHg or > 95 mmHg, or pulse rate < 50 bpm or > 110 bpm; participants of 6 to < 12 years of age with SBP < 70 mmHg or > 140 mmHg, or DBP < 40 mmHg or > 90 mmHg or pulse rate < 52 bpm or > 156 bpm; participants of 2 to < 6 years of age with SBP < 70 mmHg or > 120 mmHg, or DBP < 40 mmHg or > 80 mmHg or pulse rate < 52 bpm or > 156 bpm at Screening.
- Participants previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), calcineurin inhibitors, complement inhibitors (other than iptacopan), oral budesonide, systemic corticosteroids exposure (≥ 0.5 mg/kg/day of prednisone/prednisolone equivalent or > 7.5 mg/d prednisone/prednisolone equivalent total exposure in a single day) within 120 days (or 180 days for rituximab) prior to first study drug administration. Participants treated with endothelin (receptor) antagonists (including sparsentan) within 120 days prior to first study drug administration.
- All transplanted participants (any solid organ transplantation, including bone marrow transplantation).
- History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus.
- Major concurrent comorbidities at Screening including but not limited to advanced cardiac disease (e.g. New York Heart Association (NYHA) class III (for 6 to <18 years of age), Ross class III (for 2 to < 6 years of age), severe pulmonary disease (e.g. World Health Organization (WHO) class III (for 17 years of age); Pulmonary Vascular Research Institute (PVRI) class III (for 2 to < 17 years of age), or hepatic disease (e.g. active hepatitis) that in the opinion of the investigator precludes participation in the study.
- Current use of any homeopathic and/or herbal medications for IgAN disease progression, such as but not limited to Lei Gong Teng at Screening (and confirmed at Baseline/Day 1).
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
20 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
20 sites in 8 countries
United States5 sites, 5 recruiting
- Recruiting
Childrens Hospital Colorado
Aurora, Colorado, 80045
Claire Giachino, +1 720 777 1234, claire.giachino@childrenscolorado.org
Bradley Dixon
- Recruiting
Univ of Florida Shands Division
Gainesville, Florida, 32610-0224
Andrew Sokolow, asokolow@peds.ufl.edu
Lawrence Shoemaker
- Recruiting
Valley Childrens Hospital
Madera, California, 93636
Tania Jimenez, +1 559 486 2000, tjimenez@valleychildrens.org
Nianzhou Xiao
- Recruiting
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4399
Catherine Justice, +1 267 426 9338, justicec@chop.edu
Rebecca Scobell
- Recruiting
Prim Childrens Hosp Inv Pharm
Salt Lake City, Utah, 84113
Gabriella Gourdin, gabriella.gourdin@hsc.utah.edu
Raoul Nelson
Israel4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Beersheba, 8457108
- Recruiting
Novartis Investigative Site
Haifa, 3109601
- Recruiting
Novartis Investigative Site
Jerusalem, 9103102
- Recruiting
Novartis Investigative Site
Petah Tikva, 4920235
Japan4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Fuchū, Tokyo, 1838561
- Recruiting
Novartis Investigative Site
Kurume, Fukuoka, 8300011
- Recruiting
Novartis Investigative Site
Ōtsu, Shiga, 520-2192
- Recruiting
Novartis Investigative Site
Toyoake, Aichi-ken, 4701192
Australia2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Brisbane, Queensland, 4101
- Recruiting
Novartis Investigative Site
Nedlands, Western Australia, 6009
China2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Beijing, 100034
- Recruiting
Novartis Investigative Site
Hangzhou, Zhejiang, 310052
Argentina1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Córdoba, Córdoba Province, X5016KEH
Hong Kong1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Hong Kong, 999077
Saudi Arabia1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Riyadh, 11211
About this study
Official title: A Single-arm, Multicenter, Phase III Study to Assess Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients of 2 to <18 Years of Age With Primary Immunoglobulin A Nephropathy (IgAN)
The study is an open-label, single arm, multicenter, Phase III study to determine proteinuria reduction, pharmacokinetics (PK), safety and tolerability (including CV surveillance) of iptacopan in primary immunoglobulin A nephropathy (IgAN) pediatric patients aged 2 to <18 years.
Read the detailed description
The study will enroll approximately 34 pediatric patients with a diagnosis of primary IgAN by kidney biopsy performed within 3 years of Screening with < 50% tubulointerstitial fibrosis and <25% crescents and not previously treated with immunosuppressive or other immunomodulatory agents within 90 days (or 180 days for rituximab) prior to first study drug administration.
The study comprises the following periods:
- Screening Period (up to 11 weeks)
- Run-in Period (2 weeks): This period will be approximately 14 days prior to the Enrollment Visit (Day 1) to obtain Baseline assessments, including two UPCR FMV measurements (required prior to Day 1).
- Treatment Period ( 52 weeks): The study will enroll approximately 34 pediatric patients in a staggered manner. The approach will be to first enroll Cohort 1 (12 to < 18 years of age) to collect safety data (including CV surveillance data), tolerability data, PK data and biomarker data for up to 52 weeks (EOS). Cohort 1 participants will be enrolled in a single group of 22 participants. Cohort 2 (2 to < 12 years of age) participants will be enrolled in 2 groups with a total 12 participants.
- Follow-up Period (1 week): Participants who completed the Week 52 (EOS) visit and meet all the eligibility criteria may be enrolled in a rollover extension program (REP) in which they will receive open-label iptacopan. Participants who do not enroll in the REP or do not complete Day 1 of the REP within 7 days of the EOS, should be contacted 7 days after the EOS visit for AE and SAE monitoring and any AEs reported by the participant should be recorded in the study case report form (CRF).
- Being tested
- iptacopan
- Keywords
- Iptacopan,, primary IgA nephropathy,, IgAN,, proteinuria,, UPCR,, eGFR,, kidney function decline,, pediatric,, adolescents
- Medical subject headings
- Glomerulonephritis, IGA, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iptacopanDrug
Also called LNP023
Cohort 1 (12 to < 18 years of age): Iptacopan 200 mg b.i.d.(twice daily) Cohort 2 (2 to < 12 years old): Dosing tbd
| Study group | Role | What they receive |
|---|---|---|
| iptacopan | Experimental | Participants in Cohort 1 (12 to < 18 years old) will receive iptacopan at the dose of 200 mg twice per day. Participants in Cohort 2 (2 to < 12 years old) will receive iptacopan at a dose tbd. Receives: Drug: iptacopan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Log-transformed ratio to Baseline in UPCR (based on FMV)
UPCR is measured based on the geometric mean of 2 FMVs obtained preceding each scheduled visit.
Measured: Baseline, Week 38
Secondary outcomes (4)
Pharmacokinetic Parameter Cmax in Plasma
Cmax is the maximum (peak) observed plasma drug concentration after dose administration (mass x volume-1)
Measured: Week 12 (Pre-dose (0), 2, 4, 6, and 8 hours post-dose)
Pharmacokinetic Parameter AUClast in Plasma
AUClast is the AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1)
Measured: Week 12 (Pre-dose (0), 2, 4, 6, and 8 hours post-dose)
Pharmacokinetic Parameter AUCtau in Plasma
AUCtau is the AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1)
Measured: Week 12 (Pre-dose (0), 2, 4, 6, and 8 hours post-dose)
Ctrough concentrations
Pre-dose drug concentration
Measured: Week 4, Week 12 and Week 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start27 Nov 2025
- Primary completion28 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immunoglobulin A Nephropathy (IgAN)Studies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 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
- NCT06994845
- Sponsor's protocol ID
- CLNP023G12301
- Status last verified
- Sep 2026
- First submitted
- 20 May 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter, Phase III Study to Assess Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients of 2 to <18 Years of Age With Primary Immunoglobulin A Nephropathy (IgAN)
- ClinicalTrials.gov ID
- NCT06994845
- Acronym / sponsor ID
- CLNP023G12301
- Keywords
- Iptacopan,, primary IgA nephropathy,, IgAN,, proteinuria,, UPCR,, eGFR,, kidney function decline,, pediatric,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- 28 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 29 May 2025 (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 study is an open-label, single arm, multicenter, Phase III study to determine proteinuria reduction, pharmacokinetics (PK), safety and tolerability (including CV surveillance) of iptacopan in primary immunoglobulin A nephropathy (IgAN) pediatric patients aged 2 to <18 years.
Detailed description
The study will enroll approximately 34 pediatric patients with a diagnosis of primary IgAN by kidney biopsy performed within 3 years of Screening with < 50% tubulointerstitial fibrosis and <25% crescents and not previously treated with immunosuppressive or other immunomodulatory agents within 90 days (or 180 days for rituximab) prior to first study drug administration.
The study comprises the following periods:
- Screening Period (up to 11 weeks)
- Run-in Period (2 weeks): This period will be approximately 14 days prior to the Enrollment Visit (Day 1) to obtain Baseline assessments, including two UPCR FMV measurements (required prior to Day 1).
- Treatment Period ( 52 weeks): The study will enroll approximately 34 pediatric patients in a staggered manner. The approach will be to first enroll Cohort 1 (12 to < 18 years of age) to collect safety data (including CV surveillance data), tolerability data, PK data and biomarker data for up to 52 weeks (EOS). Cohort 1 participants will be enrolled in a single group of 22 participants. Cohort 2 (2 to < 12 years of age) participants will be enrolled in 2 groups with a total 12 participants.
- Follow-up Period (1 week): Participants who completed the Week 52 (EOS) visit and meet all the eligibility criteria may be enrolled in a rollover extension program (REP) in which they will receive open-label iptacopan. Participants who do not enroll in the REP or do not complete Day 1 of the REP within 7 days of the EOS, should be contacted 7 days after the EOS visit for AE and SAE monitoring and any AEs reported by the participant should be recorded in the study case report form (CRF).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iptacopan | Experimental | Drug: iptacopanParticipants in Cohort 1 (12 to < 18 years old) will receive iptacopan at the dose of 200 mg twice per day. Participants in Cohort 2 (2 to < 12 years old) will receive iptacopan at a dose tbd. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Male and female participants 2 to < 18 years of age as of Day 1.
- eGFR ≥ 30 mL/min/1.73m2 where eGFR is calculated using the modified Schwartz formula at Screening and confirmed during the Run-in Period.
- Kidney biopsy-proven primary IgAN*, with biopsy performed within 3 years of Screening with < 50% tubulointerstitial fibrosis and < 25% crescents. In case a kidney biopsy within 3 years from Screening is not available, a kidney biopsy may be performed if it is part of the planned diagnostic approach and clinical management of the participant.
- The minimum body weight for participants in Cohort 1 is 35 kg at Screening and confirmed at Baseline (Day 1).
- Proteinuria due to primary diagnosis of IgAN as assessed by UPCR ≥ 1 g/g (113 mg/mmoL) sampled from FMV at Screening on Day -90 and Day -60 as well as during the Run-in Period despite treatment with maximum tolerated dose of ACE inhibitor/ARB for at least 120 days prior to Day 1. Note: UPCR will be assessed based on one FMV sample at Day -90 and based on the geometric mean of 2 FMV samples for the Day -60 visit and during the Run-in Period.
Key exclusion criteria (15 listed)
- Any secondary IgAN observed at Screening (and confirmed at Baseline/Day 1) as defined by the Investigator; secondary IgAN can be associated with cirrhosis, celiac disease, human immunodeficiency virus (HIV) infection, herpes simplex virus infection, dermatitis herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, inflammatory bowel disease, and familial mediterranean fever.
- A clinical diagnosis of immunoglobulin A vasculitis (IgAV or Henoch-Schonlein purpura) based on typical palpable purpura with or without arthralgia and abdominal pain.
- Evidence of significant urinary obstruction or difficulty in voiding at Screening (and confirmed at Baseline/Day 1); any urinary tract disorder or any chronic kidney disease other than IgAN at Screening and before first study drug administration.
- Current acute kidney injury (AKI) defined by Acute Kidney Injury Network (AKIN) criteria within 4 weeks of screening.
- Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to Screening or during the Screening and Run-in periods.
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: LNP023Cohort 1 (12 to < 18 years of age): Iptacopan 200 mg b.i.d.(twice daily) Cohort 2 (2 to < 12 years old): Dosing tbd | Drug | iptacopan |
Primary outcome
Log-transformed ratio to Baseline in UPCR (based on FMV)
Time frame: Baseline, Week 38
UPCR is measured based on the geometric mean of 2 FMVs obtained preceding each scheduled visit.
4 secondary outcomes
Pharmacokinetic Parameter Cmax in Plasma
Time frame: Week 12 (Pre-dose (0), 2, 4, 6, and 8 hours post-dose)
Pharmacokinetic Parameter AUClast in Plasma
Time frame: Week 12 (Pre-dose (0), 2, 4, 6, and 8 hours post-dose)
Pharmacokinetic Parameter AUCtau in Plasma
Time frame: Week 12 (Pre-dose (0), 2, 4, 6, and 8 hours post-dose)
Ctrough concentrations
Time frame: Week 4, Week 12 and Week 38
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 Sep 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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
20 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing iptacopan in people with Primary Immunoglobulin A Nephropathy (IgAN), run by Novartis Pharmaceuticals at 20 sites in 8 countries.
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 9 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Israel, Japan, Australia, China and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Log-transformed ratio to Baseline in UPCR (based on FMV) (time frame: Baseline, Week 38). 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 Sep 2026.