A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)
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.
Timeline
- Start
- 2019-09-30
- Primary completion
- 2022-03-17
- Completion
- 2023-06-27
Outcome
Missed primary endpoint
Stopped: “Study was terminated early having identified clinically meaningful magnitude of proteinuria reduction due to cemdisiran (study goal). Participants completed DBT period\&were in OLE period. Sponsor had no concerns with safety\&integrity of participants.”
registry analysis (superiority test); DBT Period: Placebo vs DBT Period: Cemdisiran; p = 0.1032; Placebo-adjusted GM Percent Change -37.367 (90% CI -60.951 to 0.460); MMRM NCT03841448 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cemdisiran | Small interfering RNA (siRNA) | 600 mg | Subcutaneous |