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

NCT03841448 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-08-09

Study results available
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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 (ARB). These participants are at high risk for progression of kidney disease, which can result in end-stage renal failure.

Conditions

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

Interventions

DRUG

Placebo

Normal saline (0.9% NaCl) matching volume of cemdisiran doses were administered SC.

DRUG

Cemdisiran

Cemdisiran was administered by SC injection.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Alnylam Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2022-03-17
Completion
2023-06-27
FDA Drug
Yes

Countries

  • Canada
  • France
  • Malaysia
  • Philippines
  • Singapore
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03841448 on ClinicalTrials.gov