At a glance
ClinicalIndex Comparison Record- ✓Kidney biopsy-confirmed IgAN diagnosis
- ✓eGFR ≥30 mL/min/1.73 m² at Screening
- ✓Proteinuria ≥0.75 g/g or ≥1 g/day (mean of two 24-hour urine collections)
- ✓Stable maximum tolerated RASI (ACEi and/or ARB) for ≥3 months prior to Screening
- ✕Rapid progressive glomerulonephritis with eGFR loss ≥50% over 3 months prior to Screening
- ✕Secondary IgAN (SLE, cirrhosis, celiac disease; IgAV-N may be eligible)
- ✕Concomitant clinically significant renal disease other than IgAN
- ✕Prior immunosuppressive treatment within 3 months of Screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Ravulizumab and Placebo for Immunoglobulin A Nephropathy and IgAN. Active but no longer recruiting, targeting 579 participants across 246 sites in 28 countries.
Signals
Detailed Summary
The primary objective of this study to evaluate efficacy of ravulizumab compared with placebo on proteinuria reduction and change in eGFR in adult participants with IgAN who are at risk of disease progression.
Study Details
Timeline
Arms & Interventions
Participants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered every 8 weeks (q8w).
Participants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered q8w.
Interventions
Participants will receive ravulizumab via weight-based intravenous (IV) infusion.
Participants will receive placebo via weight-based IV infusion.