Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN) (ICAN)
Actively Recruiting
About This Study
This Phase 3, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of ravulizumab in approximately 510 adults with IgAN at high risk of disease progression. Participants must be on a stable standard of care regimen for at least three months prior to screening and are randomized 1:1 to receive weight-based IV infusions of ravulizumab or placebo. The primary endpoints are the reduction in proteinuria at Week 34 and the change in eGFR at Week 106. The study includes a specific cohort for patients with advanced kidney disease (eGFR 20–29 mL/min/1.73m²) to assess outcomes in late-stage progression.
Who Can Participate?
✓ Inclusion Criteria
- •Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior to or during the Screening Period for participants with eGFR ≥ 30 mL/min/1.73 m^2.
- •For participants in the AdKD cohorts, eGFR 20 to 29 mL/min/1.73 m2 a kidney biopsy is required within 6 months prior to Screening or during the Screening Period.
- •UPCR ≥ 0.75 g/g or UP ≥1 g/day calculated from the mean of two 24-hour urine during the Screening Period.
- •Estimated GFR ≥ 30 mL/min/1.73 m2 at Screening.
- •Stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for ≥ 3 months prior to Screening with no planned change during Screening through Week 106.
- •Participants who are receiving SGLT2I, DEARA, MRA or ERA must be on a stable and maximum allowed or tolerated dose for ≥ 3 months prior to Screening with no planned change in dose through Week 106.
✗ Exclusion Criteria
- •Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 50% over a period of 3 months prior to Screening.
- •Secondary IgAN (eg, due to systemic lupus erythematosus (SLE), cirrhosis, or celiac disease; IgAV-N may be eligible).
- •Concomitant clinically significant renal disease other than IgAN.
- •Prior use of immunosuppressive treatment within 3 months of screening.
- •Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%.
- •Henoch-Schonlein purpura (IgAV) requiring systemic immunosuppressive therapy within 12 months of Screening.
- •History of kidney transplant or planned kidney transplant during the Treatment Period.
- •Splenectomy or functional asplenia.
- •History of Neisseria meningitidis infection.
- •Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.