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)
Primary Objective
To evaluate the ability of ravulizumab to reduce proteinuria in adults with IgAN
Description
Access to the investigational medication (ravulizumab) will be available to participants following the double-blinded portion of the trial.
Details
Age
Adult
Eligibility
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
Locations
Outpatient CTRC
Renal Research Center
University of Colorado Hospital
Principal Investigator
Judith Blaine
Study ID
Protocol Number: 24-0436
Categories
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