Last updated on July 2020

Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy


Brief description of study

The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

Detailed Study Description

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of oral Nefecon compared to matching placebo in patients with primary IgAN on a background of optimized RAS inhibitor therapy. The study will consist of 2 parts, Part A and Part B. Part A will include a 9 month blinded Treatment Period, and a 3-month Follow up Period. Part B of the study will consist of a 12-month observational Follow up Period; no study drug will be administered during Part B. Part A and B will be blinded. Safety will be monitored by an independent Data Safety Monitoring Board.

Clinical Study Identifier: NCT03643965

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University of Florida-Gainesville

Gainesville, FL United States
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Omega Research Maitland

Orlando, FL United States
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Queens Hospital Centre

Jamaica, NY United States
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University of Pennsylvania

Philadelphia, PA United States
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University of Vermont

Burlington, VT United States
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Recruitment Status: Open


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