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Trial record 1 of 1 for:    NCT03841448
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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 : Recruiting
First Posted : February 15, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Alnylam Pharmaceuticals

Study Description
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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 and 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 Design
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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
Estimated Study Start Date : April 22, 2019
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 29, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage Change From Baseline in 24-hour Proteinuria at Week 32 [ Time Frame: Baseline, Week 32 ]

Secondary Outcome Measures :
  1. Percentage of Participants with Partial Clinical Remission at Week 32 [ Time Frame: Week 32 ]
  2. Percentage of Participants with >50% Reduction in 24-hour Proteinuria at Week 32 [ Time Frame: Week 32 ]
  3. Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) as Measured in 24-Hour Urine at Week 32 [ Time Frame: Baseline, 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. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to Week 136 ]

Eligibility Criteria
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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 (>20 mg prednisolone equivalent for more than 7 days in past 12 months), or any immunosuppressant agents in the past 12 months
  • Received an organ transplant
Contacts and Locations
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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
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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
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United States, California
Clinical Trial Site Recruiting
Lynwood, California, United States, 90262
United States, Louisiana
Clinical Trial Site Recruiting
Shreveport, Louisiana, United States, 71101
Canada, Ontario
Clinical Trial Site Recruiting
Brampton, Ontario, Canada, L6T0G1
Sponsors and Collaborators
Alnylam Pharmaceuticals
Investigators
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Study Director: Nader Najafian, MD Alnylam Pharmaceuticals
More Information
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Responsible Party: Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03841448     History of Changes
Other Study ID Numbers: ALN-CC5-005
2018-002716-27 ( EudraCT Number )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
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
Glomerulonephritis
Urologic Diseases
 Nephritis
Autoimmune Diseases
Immune System Diseases