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

  • STATUS
    Recruiting
  • End date
    Feb 28, 2025
  • participants needed
    30
  • sponsor
    Alnylam Pharmaceuticals
Updated on 27 May 2021
Investigator
Alnylam Clinical Trials Hotline
Primary Contact
Clinical Trial Site (0.0 mi away) Contact
+80 other location
renal failure
ace inhibitor
angiotensin
nephropathy
renin
immunoglobulins
proteinuria
angiotensin receptor blockers
hematuria
angiotensin converting enzyme
immunoglobulin a

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.

Details
Condition IgA nephropathy, Glomerulonephritis, Autoimmune disease
Treatment Placebo, Cemdisiran
Clinical Study IdentifierNCT03841448
SponsorAlnylam Pharmaceuticals
Last Modified on27 May 2021

Eligibility

Yes No Not Sure

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
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