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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 : November 8, 2022
Information provided by (Responsible Party):
Alnylam Pharmaceuticals

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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 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.
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 :
  1. 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 :
  1. Percent Change from Baseline in 24-Hour Proteinuria at Week 32 [ Time Frame: Baseline, Week 32 ]
  2. Percentage of Participants with Partial Clinical Remission at Week 32 [ Time Frame: Week 32 ]
  3. Percentage of Participants with >50% Reduction in 24-hour Proteinuria at Week 32 [ Time Frame: Week 32 ]
  4. Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) as Measured in a Spot Urine at Week 32 [ Time Frame: Baseline, Week 32 ]
  5. Change From Baseline in Hematuria at Week 32 [ Time Frame: Baseline, Week 32 ]
  6. Frequency of Adverse Events (AEs) [ Time Frame: Up to Week 240 ]

Information from the National Library of Medicine

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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

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

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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
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
Clinical Trial Site
Kuala Lumpur, Malaysia
Clinical Trial Site
Kuantan, Malaysia
Clinical Trial Site
Serdang, Malaysia
Clinical Trial Site
Manila, Philippines
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
Linköping, Sweden
Clinical Trial Site
Taichung, Taiwan
United Kingdom
Clinical Trial Site
Leicester, United Kingdom
Sponsors and Collaborators
Alnylam Pharmaceuticals
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Study Director: Medical Director Alnylam Pharmaceuticals
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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: November 8, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Urologic Diseases
Autoimmune Diseases
Immune System Diseases