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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)

To evaluate the ability of ravulizumab to reduce proteinuria in adults with IgAN


Why this Research Matters

Access to the investigational medication (ravulizumab) will be available to participants following the double-blinded portion of the trial.


Who can Participate

Adult

Adults with biopsy proven IgAN (immunoglobulin A nephropathy) Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior to or during the Screening Period (Section 8.1.5). UPCR ≥ 0.75 g/g or UP ≥1 g/day from the mean of two 24-hour urine collections during Screening as described in Section 8.2.1. Estimated GFR ≥ 30 mL/min/1.73 m2 at Screening. Exploratory Cohort: eGFR 20-29 mL/min/1.73 m2 at Screening. A kidney biopsy is required within 6 months prior to Screening or during the Screening Period. Kidney biopsy report must demonstrate < 75% each of interstitial fibrosis, tubular atrophy, and glomerular sclerosis. Presence of hematuria as defined by a positive result on urine dipstick for blood or ≥ 5 red blood cells (RBCs)/high power field microscopy on urine sediment during or within 3 months of Screening


Study ID

Protocol Number: 24-0436

Meet the Team

Image of Principal Investigator

Judith Blaine, MD, PhD

Principal Investigator


Locations