We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03841448
Recruitment Status : Active, not recruiting
First Posted : February 15, 2019
Last Update Posted : November 8, 2022
Sponsor:
Information provided by (Responsible Party):
Alnylam Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 13, 2019
First Posted Date  ICMJE February 15, 2019
Last Update Posted Date November 8, 2022
Actual Study Start Date  ICMJE April 24, 2019
Actual Primary Completion Date March 17, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2020)
Percentage Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) as Measured in 24-hour Urine at Week 32 [ Time Frame: Baseline, Week 32 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
Percentage Change From Baseline in 24-hour Proteinuria at Week 32 [ Time Frame: Baseline, Week 32 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2021)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
  • 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 24-Hour Urine at Week 32 [ Time Frame: Baseline, 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 ]
  • Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to Week 136 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)
Official Title  ICMJE A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients With IgA Nephropathy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • IgA Nephropathy (IgAN)
  • Berger Disease
  • Glomerulonephritis, IgA
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Cemdisiran
    Participants will receive cemdisiran during the Treatment and optional Open-Label Extension (OLE) Periods in combination with standard of care.
    Intervention: Drug: Cemdisiran
  • 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.
    Interventions:
    • Drug: Placebo
    • Drug: Cemdisiran
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 15, 2021)
31
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2019)
30
Estimated Study Completion Date  ICMJE February 28, 2025
Actual Primary Completion Date March 17, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Malaysia,   Philippines,   Singapore,   Spain,   Sweden,   Taiwan,   United Kingdom
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT03841448
Other Study ID Numbers  ICMJE ALN-CC5-005
2018-002716-27 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Alnylam Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Alnylam Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Alnylam Pharmaceuticals
PRS Account Alnylam Pharmaceuticals
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP