A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN)

Conditions

Immunoglobulin A Nephropathy (IgAN)

Brief summary

Interim Analysis: Change from baseline in proteinuria based on 24-hour UPCR at Week 34 Final Analysis: Change from Baseline in eGFR at Week 106

Detailed description

Interim Analysis: Change from Baseline in proteinuria based on 24-hour UPCR at Weeks 10 and 26 Final Analysis: Change from Baseline in proteinuria based on 24-hour UPCR at Week 10, 26, 34, 50 and 106, Interim Analysis: Change from Baseline in eGFR at Week 34 Final Analysis: Change from Baseline in eGFR at Weeks 34 and 50, Interim Analysis: Reduction in 24-hour UPCR ≥ 50% from Baseline over time Final Analysis: Reduction in 24-hour UPCR ≥ 50% from Baseline at Week 34 and over time, Interim Analysis: Partial remission over time final analysis: Partial remission over time, Interim Analysis: Change from Baseline in albuminuria over time final analysis: Change from Baseline in albuminuria over time, Interim Analysis: Annualized eGFR slope over 50 weeks Final analysis: Time to sustained ≥ 30% eGFR decline up to Week 106, Final analysis: Time to individual components of composite kidney event endpoint up to Week 106, interim analysis: Change from Baseline in FACIT-Fatigue at Weeks 34, 50, and 106 final analysis: Change from Baseline in FACIT-Fatigue at Weeks 34, 50, and 106, interim and final analysis: Incidence of TEAEs, TESAEs, and AESI over time, interim and final analysis: ADA incidence, response categories, and titers; as well as NAb incidence for the duration for the study, interim and final analysis: • Serum ravulizumab concentrations over time • Serum total C5 and free C5 concentrations over time, Final Analysis: Time to first occurrence of composite kidney event endpoint up to Week 106, defined as reaching at least 1 of the following: −Sustained ≥ 30% decline in eGFR relative to Baselinea, or −Sustained eGFR < 15 mL/min/1.73 m2, or −Maintenance dialysis, or −Receipt of kidney transplant, or −Death from kidney failure, Final analysis: Time to sustained eGFR declinea ≥ 40% up to Week 106, Final Analysis: Time to individual components of composite kidney event endpoint up to Week 106, Final analysis: Use of alternative IgAN therapy over time

Narayan Cheruvu, Katherine Garlo, Andreas Kateifides, Joyce Chen, Kara Rice et al. (6 authors)

Nephrology Dialysis Transplantation2025-10-01

10.1093/ndt/gfaf116.0341

#3060 A phase 3, open-label, multicenter study of ravulizumab in pediatric patients with IgA nephropathy or IgA vasculitis-associated nephritis

Andreas Kateifides, Katherine Garlo, Youssef M.K. Farag, Stephen Nolan, H Wasim et al. (7 authors)

Nephrology Dialysis Transplantation2025-10-01

10.1093/ndt/gfaf116.0342

Interventions

DRUGAnti C5 Complement mAb Placebo

DRUGUltomiris 1

DRUG100 mg/11 mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Interim Analysis: Change from baseline in proteinuria based on 24-hour UPCR at Week 34 Final Analysis: Change from Baseline in eGFR at Week 106	—

Secondary

Measure	Time frame
Interim Analysis: Change from Baseline in proteinuria based on 24-hour UPCR at Weeks 10 and 26 Final Analysis: Change from Baseline in proteinuria based on 24-hour UPCR at Week 10, 26, 34, 50 and 106, Interim Analysis: Change from Baseline in eGFR at Week 34 Final Analysis: Change from Baseline in eGFR at Weeks 34 and 50, Interim Analysis: Reduction in 24-hour UPCR ≥ 50% from Baseline over time Final Analysis: Reduction in 24-hour UPCR ≥ 50% from Baseline at Week 34 and over time, Interim Analysis: Partial remission over time final analysis: Partial remission over time, Interim Analysis: Change from Baseline in albuminuria over time final analysis: Change from Baseline in albuminuria over time, Interim Analysis: Annualized eGFR slope over 50 weeks Final analysis: Time to sustained ≥ 30% eGFR decline up to Week 106, Final analysis: Time to individual components of composite kidney event endpoint up to Week 106, interim analysis: Change from Baseline in FACIT-Fatigue at Weeks 34, 50,	—

Measure

Time frame

Interim Analysis: Change from Baseline in proteinuria based on 24-hour UPCR at Weeks 10 and 26 Final Analysis: Change from Baseline in proteinuria based on 24-hour UPCR at Week 10, 26, 34, 50 and 106, Interim Analysis: Change from Baseline in eGFR at Week 34 Final Analysis: Change from Baseline in eGFR at Weeks 34 and 50, Interim Analysis: Reduction in 24-hour UPCR ≥ 50% from Baseline over time Final Analysis: Reduction in 24-hour UPCR ≥ 50% from Baseline at Week 34 and over time, Interim Analysis: Partial remission over time final analysis: Partial remission over time, Interim Analysis: Change from Baseline in albuminuria over time final analysis: Change from Baseline in albuminuria over time, Interim Analysis: Annualized eGFR slope over 50 weeks Final analysis: Time to sustained ≥ 30% eGFR decline up to Week 106, Final analysis: Time to individual components of composite kidney event endpoint up to Week 106, interim analysis: Change from Baseline in FACIT-Fatigue at Weeks 34, 50,

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Countries

Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Slovakia, Spain

Outcome results

None listed