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

  • STATUS
    Recruiting
  • End date
    Feb 26, 2023
  • participants needed
    360
  • sponsor
    Calliditas Therapeutics AB
Updated on 4 August 2021
Investigator
Medpace Research, Inc
Primary Contact
Universitaetsklinikum Erlangen, Medizinisches Klinik 4, Ulmenweg 18 (8.7 mi away) Contact
+153 other location

Summary

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).

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.

Details
Condition IgA nephropathy, primary iga nephropathy
Treatment Placebo oral capsule, Nefecon
Clinical Study IdentifierNCT03643965
SponsorCalliditas Therapeutics AB
Last Modified on4 August 2021

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