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)
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.
Inclusion Criteria:
Exclusion Criteria:
Birmingham, Alabama 35294-3412, United States
Torrance, California 90502, United States
Aurora, Colorado 80045, United States
Westminster, Colorado 80031, United States
Washington D.C., District of Columbia 20037, United States
Chicago, Illinois 60611, United States
Lexington, Kentucky 40536, United States
Springfield, Massachusetts 01107, United States
New York, New York 10029, United States
New York, New York 10032, United States
Chapel Hill, North Carolina 27599, United States
Wilmington, North Carolina 28401, United States
Cleveland, Ohio 44195, United States
Columbus, Ohio 43210, United States
Portland, Oregon 97239, United States
Capital Federal, C1280AEB, Argentina
Córdoba, 5016, Argentina
Pilar, B16290DT, Argentina
Santa Fe, 3000, Argentina
Parkville, 3052, Australia
St Albans, 3021, Australia
Woolloongabba, 4102, Australia
Brussels, 1070, Belgium
Liège, 4000, Belgium
Kamloops, British Columbia V2C 2T1, Canada
Kelowna, British Columbia V1Y 1T2, Canada
Vancouver, British Columbia V5T 3A5, Canada
Toronto, Ontario M5G2C4, Canada
Greenfield Park, Quebec J4V 2H1, Canada
Sherbrooke, Quebec J1H 5N4, Canada
Helsinki, 00290, Finland
Tampere, 33520, Finland
Boulogne-sur-Mer, 62321, France
Grenoble, 30043, France
Montpellier, 34295, France
Saint-Priest-en-Jarez, 42270, France
Valenciennes, 59322, France
Dresden, 01307, Germany
Heidelberg, 69120, Germany
Lübeck, 23538, Germany
Munich, 80336, Germany
Regensburg, 93053, Germany
Heraklion, 71100, Greece
Ioannina, 45110, Greece
Nikaia, 18454, Greece
Thessaloniki, 54642, Greece
Pavia, 27100, Italy
Lodz, 92-213, Poland
Olsztyn, 10-561, Poland
Gyeonggi-do, 14068, South Korea
Madrid, 28007, Spain
Madrid, 28041, Spain
Adana, 01330, Turkey (Türkiye)
Istanbul, 34098, Turkey (Türkiye)
Izmir, 35100, Turkey (Türkiye)
Kayseri, 38039, Turkey (Türkiye)
Kocaeli, 41000, Turkey (Türkiye)
Glasgow, G51 4TF, United Kingdom