Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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

Official Title

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

Keywords

IgA Nephropathy (IgAN) Berger Disease Glomerulonephritis, IgA Kidney Diseases Glomerulonephritis Cemdisiran

Eligibility

You can join if…

Open to people ages 18-65

  • 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)

You CAN'T join if...

  • 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 m2

  • 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 12 months
  • Received an organ transplant

Locations

  • Clinical Trial Site accepting new patients
    San Francisco California 94143-2202 United States
  • Clinical Trial Site accepting new patients
    Northridge California 91325 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alnylam Pharmaceuticals
ID
NCT03841448
Phase
Phase 2
Study Type
Interventional
Last Updated