A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)
NCT ID: NCT03841448
Last Updated: 2024-08-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
31 participants
INTERVENTIONAL
2019-09-30
2023-06-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Double-Blind Treatment (DBT) Period: Cemdisiran
Participants received cemdisiran, 600 milligrams (mg), subcutaneous (SC) injection, once every 4 weeks (Q4W) in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
Cemdisiran
Cemdisiran was administered by SC injection.
DBT Period: Placebo
Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
Placebo
Normal saline (0.9% NaCl) matching volume of cemdisiran doses were administered SC.
DBT Period: Cemdisiran to Open-Label Extension (OLE) Period: Cemdisiran
Participants who were randomized to receive cemdisiran in the DBT period continued receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period.
Cemdisiran
Cemdisiran was administered by SC injection.
DBT Period: Placebo to OLE Period: Cemdisiran
Participants who were randomized to receive cemdisiran matching placebo in the DBT period started receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period.
Cemdisiran
Cemdisiran was administered by SC injection.
Interventions
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Placebo
Normal saline (0.9% NaCl) matching volume of cemdisiran doses were administered SC.
Cemdisiran
Cemdisiran was administered by SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Alnylam Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Alnylam Pharmaceuticals
Locations
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Clinical Trial Site
Vancouver, British Columbia, Canada
Clinical Trial Site
Brampton, Ontario, Canada
Clinical Trial Site
Toronto, Ontario, Canada
Clinical Trial Site
Grenoble, , France
Clinical Trial Site
La Tronche, , France
Clinical Trial Site
Mulhouse, , France
Clinical Trial Site
Kuala Lumpur, , Malaysia
Clinical Trial Site
Kuantan, , Malaysia
Clinical Trial Site
Serdang, , Malaysia
Clinical Trial Site
Quezon City, , Philippines
Clinical Trial Site
Singapore, , Singapore
Clinical Trial Site
Córdoba, , Spain
Clinical Trial Site
Girona, , Spain
Clinical Trial Site
Huddinge, , Sweden
Clinical Trial Site
Uppsala, , Sweden
Clinical Trial Site
Taichung, , Taiwan
Clinical Trial Site
Leicester, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-002716-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALN-CC5-005
Identifier Type: -
Identifier Source: org_study_id
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