A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)
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ClinicalTrials.gov Identifier: NCT03841448 |
Recruitment Status :
Active, not recruiting
First Posted : February 15, 2019
Last Update Posted : June 7, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
IgA Nephropathy (IgAN) Berger Disease Glomerulonephritis, IgA | Drug: Placebo Drug: Cemdisiran | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 : | April 24, 2019 |
Actual Primary Completion Date : | March 17, 2022 |
Estimated Study Completion Date : | February 28, 2025 |

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.
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Drug: Cemdisiran
Cemdisiran will be administered by subcutaneous (SC) injection.
Other Name: 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.
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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 Name: ALN-CC5 |
- Percentage Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) as Measured in 24-hour Urine at Week 32 [ Time Frame: Baseline, Week 32 ]
- Percent Change from Baseline in 24-Hour Proteinuria at Week 32 [ Time Frame: Baseline, Week 32 ]
- Percentage of Participants with Partial Clinical Remission at Week 32 [ Time Frame: Week 32 ]
- Percentage of Participants with >50% Reduction in 24-hour Proteinuria at Week 32 [ Time Frame: Week 32 ]
- Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) as Measured in a Spot Urine at Week 32 [ Time Frame: Baseline, Week 32 ]
- Change From Baseline in Hematuria at Week 32 [ Time Frame: Baseline, Week 32 ]
- Frequency of Adverse Events (AEs) [ Time Frame: Up to Week 240 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841448
Canada, British Columbia | |
Clinical Trial Site | |
Vancouver, British Columbia, Canada | |
Canada, Ontario | |
Clinical Trial Site | |
Brampton, Ontario, Canada, L6T0G1 | |
Clinical Trial Site | |
Toronto, Ontario, Canada, M5G2C4 | |
France | |
Clinical Trial Site | |
Annonay, France | |
Clinical Trial Site | |
Caen, France | |
Clinical Trial Site | |
La Tronche, France | |
Clinical Trial Site | |
Mulhouse, France | |
Clinical Trial Site | |
Paris, France | |
Malaysia | |
Clinical Trial Site | |
Kuala Lumpur, Malaysia | |
Clinical Trial Site | |
Kuantan, Malaysia | |
Clinical Trial Site | |
Serdang, Malaysia | |
Philippines | |
Clinical Trial Site | |
Manila, Philippines | |
Clinical Trial Site | |
Quezon City, Philippines | |
Singapore | |
Clinical Trial Site | |
Singapore, Singapore | |
Spain | |
Clinical Trial Site | |
Córdoba, Spain | |
Clinical Trial Site | |
Girona, Spain | |
Sweden | |
Clinical Trial Site | |
Huddinge, Sweden | |
Clinical Trial Site | |
Linköping, Sweden | |
Taiwan | |
Clinical Trial Site | |
Taichung, Taiwan | |
United Kingdom | |
Clinical Trial Site | |
Leicester, United Kingdom |
Study Director: | Medical Director | Alnylam Pharmaceuticals |
Responsible Party: | Alnylam Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03841448 |
Other Study ID Numbers: |
ALN-CC5-005 2018-002716-27 ( EudraCT Number ) |
First Posted: | February 15, 2019 Key Record Dates |
Last Update Posted: | June 7, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Kidney Diseases Glomerulonephritis, IGA Glomerulonephritis Urologic Diseases |
Nephritis Autoimmune Diseases Immune System Diseases |