Trial record 1 of 1 for:
NCT03841448
A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)
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| ClinicalTrials.gov Identifier: NCT03841448 |
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Recruitment Status :
Recruiting
First Posted : February 15, 2019
Last Update Posted : April 19, 2021
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Sponsor:
Alnylam Pharmaceuticals
Information provided by (Responsible Party):
Alnylam Pharmaceuticals
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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 |
|---|---|---|
| IgA Nephropathy (IgAN) Berger Disease Glomerulonephritis, IgA | Drug: Placebo Drug: Cemdisiran | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| 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 |
| Estimated Primary Completion Date : | February 28, 2022 |
| Estimated Study Completion Date : | February 28, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Kidney Diseases
| Arm | Intervention/treatment |
|---|---|
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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 |
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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 |
Primary Outcome Measures :
- Percentage Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) as Measured in 24-hour Urine at Week 32 [ Time Frame: Baseline, Week 32 ]
Secondary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
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
Contacts
| Contact: Alnylam Clinical Trial Information Line | 1-877-ALNYLAM | clinicaltrials@alnylam.com | |
| Contact: Alnylam Clinical Trial Information Line | 1-877-256-9526 | clinicaltrials@alnylam.com |
Locations
| United States, California | |
| Clinical Trial Site | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Clinical Trial Site | Withdrawn |
| Lynwood, California, United States, 90262 | |
| Clinical Trial Site | Recruiting |
| Northridge, California, United States, 91325 | |
| Clinical Trial Site | Recruiting |
| San Francisco, California, United States, 94143-2202 | |
| United States, Louisiana | |
| Clinical Trial Site | Recruiting |
| Shreveport, Louisiana, United States, 71101 | |
| United States, Maryland | |
| Clinical Trial Site | Recruiting |
| Baltimore, Maryland, United States, 21218 | |
| United States, Minnesota | |
| Clinical Trial Site | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Clinical Trial Site | Recruiting |
| Kansas City, Missouri, United States, 64111 | |
| United States, South Carolina | |
| Clinical Trial Site | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Clinical Trial Site | Recruiting |
| Columbia, South Carolina, United States, 29203 | |
| United States, Wisconsin | |
| Clinical Trial Site | Recruiting |
| Madison, Wisconsin, United States, 53726 | |
| Canada, British Columbia | |
| Clinical Trial Site | Recruiting |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| Clinical Trial Site | Recruiting |
| Brampton, Ontario, Canada, L6T0G1 | |
| Clinical Trial Site | Recruiting |
| Toronto, Ontario, Canada, M5G2C4 | |
| Canada | |
| Clinical Trial Site | Recruiting |
| Montréal, Canada | |
| France | |
| Clinical Trial Site | Recruiting |
| Annonay, France | |
| Clinical Trial Site | Recruiting |
| Caen, France | |
| Clinical Trial Site | Recruiting |
| Clermont-Ferrand, France | |
| Clinical Trial Site | Recruiting |
| La Tronche, France | |
| Clinical Trial Site | Recruiting |
| Mulhouse, France | |
| Clinical Trial Site | Recruiting |
| Nîmes, France | |
| Clinical Trial Site | Completed |
| Paris, France | |
| Malaysia | |
| Clinical Trial Site | Recruiting |
| Kuala Lumpur, Malaysia | |
| Clinical Trial Site | Recruiting |
| Kuantan, Malaysia | |
| Clinical Trial Site | Recruiting |
| Serdang, Malaysia | |
| Philippines | |
| Clinical Trial Site | Recruiting |
| Manila, Philippines | |
| Clinical Trial Site | Recruiting |
| Quezon City, Philippines | |
| Singapore | |
| Clinical Trial Site | Recruiting |
| Singapore, Singapore | |
| Spain | |
| Clinical Trial Site | Withdrawn |
| Alcorcón, Spain | |
| Clinical Trial Site | Recruiting |
| Barcelona, Spain | |
| Clinical Trial Site | Recruiting |
| Córdoba, Spain | |
| Clinical Trial Site | Recruiting |
| Girona, Spain | |
| Clinical Trial Site | Recruiting |
| Hospitalet de Llobregat, Spain | |
| Clinical Trial Site | Withdrawn |
| Lleida, Spain | |
| Sweden | |
| Clinical Trial Site | Recruiting |
| Huddinge, Sweden | |
| Clinical Trial Site | Recruiting |
| Linköping, Sweden | |
| Clinical Trial Site | Recruiting |
| Uppsala, Sweden | |
| Taiwan | |
| Clinical Trial Site | Recruiting |
| Taipei City, Zhongshan District, Taiwan | |
| Clinical Trial Site | Withdrawn |
| Taipei, Zhongzheng District, Taiwan | |
| Clinical Trial Site | Recruiting |
| Kaohsiung, Taiwan | |
| Clinical Trial Site | Recruiting |
| Keelung, Taiwan | |
| Clinical Trial Site | Recruiting |
| Taichung, Taiwan | |
| Clinical Trial Site | Recruiting |
| Taoyuan City, Taiwan | |
| United Kingdom | |
| Clinical Trial Site | Recruiting |
| Leicester, United Kingdom | |
| Clinical Trial Site | Recruiting |
| London, United Kingdom | |
Sponsors and Collaborators
Alnylam Pharmaceuticals
Investigators
| 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: | April 19, 2021 |
| Last Verified: | April 2021 |
| 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 |
Additional relevant MeSH terms:
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Kidney Diseases Glomerulonephritis, IGA Glomerulonephritis Urologic Diseases |
Nephritis Autoimmune Diseases Immune System Diseases |