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

Primary Purpose

IgA Nephropathy (IgAN), Berger Disease, Glomerulonephritis, IgA

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Cemdisiran
Sponsored by
Alnylam Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy (IgAN)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cemdisiran

Placebo

Arm Description

Participants will receive cemdisiran during the Treatment and optional Open-Label Extension (OLE) Periods in combination with standard of care.

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.

Outcomes

Primary Outcome Measures

Percentage Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) as Measured in 24-hour Urine at Week 32

Secondary Outcome Measures

Percent Change from Baseline in 24-Hour Proteinuria at Week 32
Percentage of Participants with Partial Clinical Remission at Week 32
Percentage of Participants with >50% Reduction in 24-hour Proteinuria at Week 32
Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) as Measured in a Spot Urine at Week 32
Change From Baseline in Hematuria at Week 32
Frequency of Adverse Events (AEs)

Full Information

First Posted
February 13, 2019
Last Updated
March 18, 2023
Sponsor
Alnylam Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03841448
Brief Title
A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)
Official Title
A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients With IgA Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
March 17, 2022 (Actual)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alnylam Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy (IgAN), Berger Disease, Glomerulonephritis, IgA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cemdisiran
Arm Type
Experimental
Arm Description
Participants will receive cemdisiran during the Treatment and optional Open-Label Extension (OLE) Periods in combination with standard of care.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal saline (0.9% NaCl) matching volume of cemdisiran doses will be administered SC.
Intervention Type
Drug
Intervention Name(s)
Cemdisiran
Other Intervention Name(s)
ALN-CC5
Intervention Description
Cemdisiran will be administered by subcutaneous (SC) injection.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Percent Change from Baseline in 24-Hour Proteinuria at Week 32
Time Frame
Baseline, Week 32
Title
Percentage of Participants with Partial Clinical Remission at Week 32
Time Frame
Week 32
Title
Percentage of Participants with >50% Reduction in 24-hour Proteinuria at Week 32
Time Frame
Week 32
Title
Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) as Measured in a Spot Urine at Week 32
Time Frame
Baseline, Week 32
Title
Change From Baseline in Hematuria at Week 32
Time Frame
Baseline, Week 32
Title
Frequency of Adverse Events (AEs)
Time Frame
Up to Week 240

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Alnylam Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Trial Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Clinical Trial Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T0G1
Country
Canada
Facility Name
Clinical Trial Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2C4
Country
Canada
Facility Name
Clinical Trial Site
City
Annonay
Country
France
Facility Name
Clinical Trial Site
City
Caen
Country
France
Facility Name
Clinical Trial Site
City
La Tronche
Country
France
Facility Name
Clinical Trial Site
City
Mulhouse
Country
France
Facility Name
Clinical Trial Site
City
Paris
Country
France
Facility Name
Clinical Trial Site
City
Kuala Lumpur
Country
Malaysia
Facility Name
Clinical Trial Site
City
Kuantan
Country
Malaysia
Facility Name
Clinical Trial Site
City
Serdang
Country
Malaysia
Facility Name
Clinical Trial Site
City
Manila
Country
Philippines
Facility Name
Clinical Trial Site
City
Quezon City
Country
Philippines
Facility Name
Clinical Trial Site
City
Singapore
Country
Singapore
Facility Name
Clinical Trial Site
City
Córdoba
Country
Spain
Facility Name
Clinical Trial Site
City
Girona
Country
Spain
Facility Name
Clinical Trial Site
City
Huddinge
Country
Sweden
Facility Name
Clinical Trial Site
City
Linköping
Country
Sweden
Facility Name
Clinical Trial Site
City
Taichung
Country
Taiwan
Facility Name
Clinical Trial Site
City
Leicester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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