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

• Status: Active, not recruiting
• Trial end date: 2025-02-28
• Target enrollment: 0
• Participant gender: All

Summary

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 (ARBs). These patients are at high risk for progression of kidney disease, which can result in end-stage renal failure.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alnylam Pharmaceuticals

Criteria

Inclusion Criteria:

• Diagnosed with primary IgAN

• Currently being treated for IgAN with stable, optimal therapy, including an ACE inhibitor or an ARB or a direct renin-inhibitor

• 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 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