This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ravulizumab compared with placebo in participants with primary IgAN on optimal treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin II receptor blockers (ARBs) who are at risk of progressing to end stage kidney disease (ESKD).
I CAN
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)
the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A
Nephropathy (IgAN)
IgA
All genders
18+
Recruiting now
Overview
Principal Investigator: Lesley Inker
Contact Us
Hannah Rick
Study details
Inclusion Criteria
- 1. Biopsy proven IgAN
- 2. Receiving a maximally tolerated and stable dose of a renin-angiotensin system
inhibitor (RASi) for at least 3 months prior to screening - 3. eGFR ≥ 30 mL/min/1.73 m^2 at screening based on the CKD-EPI equation
Exclusion Criteria
- 1. Concomitant clinically significant renal disease other than IgAN
- 2. History of organ transplant
- 3. History of malignancy within 5 years of Screening
Study Requirements
Duration of participation is up to 112 weeks with up to 17 visits. IV study drug or placebo administration occurs once every 8 weeks. A maximum of 454mL of blood will be collected in total during the treatment period. There will be a total of seven 24-hour urine collections. ECGs will also be performed at certain visits.