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Study of efficacy and safety of iptacopan in complement 3 glomerulopathy patients
EU CTIS ID: 2023-509331-83-00
What this study is testing
Primary objective in adult participants: To demonstrate the superiority of iptacopan compared to placebo in reducing proteinuria. Primary objective in adolescent participants: To evaluate the effect of iptacopan on proteinuria at 6 months.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female participants age ≥ 18 and ≤ 60 years (adult cohort) or age ≥ 12 and ≤ 17 years (adolescent cohort) at screening.
- Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to screening in adults and within 3 years of screening in adolescents (a biopsy report, review and confirmation by the Investigator is required). If such a biopsy is not available, confirmation may be obtained using tissue from the Day -45 biopsy (adults only) for local assessment (tissue may be processed, evaluated, and reported by Arkana Laboratories but eligibility is determined by the Investigator).
- Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of renin-angiotensin system inhibitors (RASi), e.g., an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) for at least 90 days. The doses of other antiproteinuric medications including mycophenolic acids, corticosteroids, and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization.
- Reduced serum C3 (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening.
- UPCR ≥ 1.0 g/g sampled from the first morning void urine sample at Day -75 and Day -15.
- Estimated GFR (using the CKD-EPI formula for adults and modified Schwartz formula for adolescents) or measured GFR ≥ 30 ml/min/1.73m2 at Screening and Day -15.
You likely can't join if
- Participants who have received any cell or organ transplantation, including kidney transplantation.
- Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli.
- Renal biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%.
- Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.
- Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration or the presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.
- A history of recurrent invasive infections caused by encapsulated organisms, e.g., meningococcus or pneumococcus.
See the full eligibility criteria
Who can join
- Male and female participants age ≥ 18 and ≤ 60 years (adult cohort) or age ≥ 12 and ≤ 17 years (adolescent cohort) at screening.
- Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to screening in adults and within 3 years of screening in adolescents (a biopsy report, review and confirmation by the Investigator is required). If such a biopsy is not available, confirmation may be obtained using tissue from the Day -45 biopsy (adults only) for local assessment (tissue may be processed, evaluated, and reported by Arkana Laboratories but eligibility is determined by the Investigator).
- Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of renin-angiotensin system inhibitors (RASi), e.g., an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) for at least 90 days. The doses of other antiproteinuric medications including mycophenolic acids, corticosteroids, and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization.
- Reduced serum C3 (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening.
- UPCR ≥ 1.0 g/g sampled from the first morning void urine sample at Day -75 and Day -15.
- Estimated GFR (using the CKD-EPI formula for adults and modified Schwartz formula for adolescents) or measured GFR ≥ 30 ml/min/1.73m2 at Screening and Day -15.
- Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection prior to the start of study treatment. If the patient has not been previously vaccinated, or if a booster is required, the vaccine should be given according to local guidelines at least 2 weeks prior to the first administration of study treatment. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated.
- Vaccination against Haemophilus influenzae infections is recommended according to local guidelines, at least 2 weeks prior to the first study treatment administration.
- In Germany only, adolescent participants must also have reached Tanner stage IV or V at the Screening visit to be enrolled in the study.
What rules you out
- Participants who have received any cell or organ transplantation, including kidney transplantation.
- Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli.
- Renal biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%.
- Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.
- Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration or the presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.
- A history of recurrent invasive infections caused by encapsulated organisms, e.g., meningococcus or pneumococcus.
- The use of inhibitors of complement factors (e.g., Factor B, Factor D, C3 inhibitors, anti Complement component 5 (C5) antibodies, C5a receptor antagonists) within 6 months prior to the Screening visit.
- The use of immunosuppressants (except mycophenolic acids), cyclophosphamide or systemic prednisone at a dose >7.5 mg/day (or equivalent for a similar medication) within 90 days of study drug administration. The use of mycophenolic acids is not permitted within 90 days prior to randomization in India.
- Acute post-infectious glomerulonephritis at screening based upon the opinion of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- Japan
- Israel
- Turkey
- Brazil
- United Kingdom
- India
- China
- United Arab Emirates
- Argentina
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; Japan; Israel; Turkey; Brazil and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.