A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)

A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients With IgA Nephropathy

The purpose of this study is to evaluate the effect of cemdisiran on proteinuria in adults with immunoglobulin A nephropathy (IgAN), who excrete >1 gram (gm) of protein per day despite standard of care, which includes treatment with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB). These participants are at high risk for progression of kidney disease, which can result in end-stage renal failure.

Inclusion Criteria:

• Diagnosed with primary IgAN
• Currently being treated for IgAN with stable, optimal therapy, including an ACE inhibitor or ARB.
• Has urine protein greater than or equal to 1 gram/24-hour
• Has hematuria (blood cells present in urine)

Exclusion Criteria:

• Has renal disease other than IgAN
• Has a diagnosis of rapidly progressive glomerulonephritis
• Has a diagnosis of Henoch-Schonlein Purpura (IgA Vasculitis)
• Has poor kidney function with estimated glomerular filtration rate (eGFR) <30 milliliters per minute per 1.73 meters square (mL/min/1.73 m^2)
• Has known human immunodeficiency virus (HIV) infection, hepatitis C virus (HCV) infection or hepatitis B virus (HBV) infection
• Has on-going high blood pressure
• Treated with systemic corticosteroids for more than 7 days, or other immunosuppressant agents in the past 6 months
• Received an organ transplant