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

Sponsor
Alnylam Pharmaceuticals (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03841448
Collaborator
(none)
31
Enrollment
20
Locations
2
Arms
70.2
Anticipated Duration (Months)
1.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients With IgA Nephropathy
Actual Study Start Date :
Apr 24, 2019
Actual Primary Completion Date :
Mar 17, 2022
Anticipated Study Completion Date :
Feb 28, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cemdisiran

Participants will receive cemdisiran during the Treatment and optional Open-Label Extension (OLE) Periods in combination with standard of care.

Drug: Cemdisiran
Cemdisiran will be administered by subcutaneous (SC) injection.
Other Names:
  • ALN-CC5

    		•
    Placebo Comparator: Placebo

    Participants will receive matching placebo during the Treatment Period in combination with standard of care. During the optional OLE Period participants will receive cemdisiran in combination with standard of care.

    Drug: Placebo
    Normal saline (0.9% NaCl) matching volume of cemdisiran doses will be administered SC.

    Drug: Cemdisiran
    Cemdisiran will be administered by subcutaneous (SC) injection.
    Other Names:
  • ALN-CC5

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) as Measured in 24-hour Urine at Week 32 [Baseline, Week 32]

    Secondary Outcome Measures

    1. Percent Change from Baseline in 24-Hour Proteinuria at Week 32 [Baseline, Week 32]

    2. Percentage of Participants with Partial Clinical Remission at Week 32 [Week 32]

    3. Percentage of Participants with >50% Reduction in 24-hour Proteinuria at Week 32 [Week 32]

    4. Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) as Measured in a Spot Urine at Week 32 [Baseline, Week 32]

    5. Change From Baseline in Hematuria at Week 32 [Baseline, Week 32]

    6. Frequency of Adverse Events (AEs) [Up to Week 240]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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 Annonay France
    5 Clinical Trial Site Caen France
    6 Clinical Trial Site La Tronche France
    7 Clinical Trial Site Mulhouse France
    8 Clinical Trial Site Paris France
    9 Clinical Trial Site Kuala Lumpur Malaysia
    10 Clinical Trial Site Kuantan Malaysia
    11 Clinical Trial Site Serdang Malaysia
    12 Clinical Trial Site Manila Philippines
    13 Clinical Trial Site Quezon City Philippines
    14 Clinical Trial Site Singapore Singapore
    15 Clinical Trial Site Córdoba Spain
    16 Clinical Trial Site Girona Spain
    17 Clinical Trial Site Huddinge Sweden
    18 Clinical Trial Site Linköping Sweden
    19 Clinical Trial Site Taichung Taiwan
    20 Clinical Trial Site Leicester United Kingdom

    Sponsors and Collaborators

    • Alnylam Pharmaceuticals

    Investigators

    • Study Director: Medical Director, Alnylam Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alnylam Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT03841448
    Other Study ID Numbers:
    • ALN-CC5-005
    • 2018-002716-27
    First Posted:
    Feb 15, 2019
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Kidney Diseases
    Glomerulonephritis, IGA
    Glomerulonephritis

    Study Results

    No Results Posted as of Aug 15, 2022