Status:
TERMINATED
A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)
Lead Sponsor:
Alnylam Pharmaceuticals
Conditions:
IgA Nephropathy (IgAN)
Berger Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 ca...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03841448
Start Date
September 30 2019
End Date
June 27 2023
Last Update
August 9 2024
Active Locations (17)
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1
Clinical Trial Site
Vancouver, British Columbia, Canada
2
Clinical Trial Site
Brampton, Ontario, Canada, L6T0G1
3
Clinical Trial Site
Toronto, Ontario, Canada, M5G2C4
4
Clinical Trial Site
Grenoble, France