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A Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd)
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).
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Alabama at Birmingham, 1720 2nd Ave South
Birmingham, Alabama, United States
Univ of Arizona, 1501 N Campbell Ave
Tucson, Arizona, United States
Stanford University Medical Center, 777 Welch Rd
Palo Alto, California, United States
Los Angeles Biomedical Research Institute at HUMC, 1124 W. Carson Street
Torrance, California, United States
University of Colorado Health Science Center, 1200 East 19th Av.
Aurora, Colorado, United States
Western Nephrology and Metabolic Bone Disease, PC-Westerminster, 8410 Decatur St.
Westminster, Colorado, United States
Yale University School of Medicine, 330 Cedar Street
New Haven, Connecticut, United States
Washington Nephrology Associates-Washington DC, 730 24th Street NW
Washington D.C., District of Columbia, United States
University of Florida-Gainesville
Gainesville, Florida, United States
Omega Research Maitland, 7912 Forest City Rd.
Orlando, Florida, United States
Start Date
September 5, 2018
Primary Completion Date
July 10, 2023
Completion Date
July 10, 2023
Last Updated
December 3, 2024
365
ACTUAL participants
Nefecon
DRUG
Placebo oral capsule
DRUG
Lead Sponsor
Calliditas Therapeutics AB
NCT05797610
NCT06982040
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06589752