Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

July 20, 2023

Primary Completion Date

October 22, 2025

Study Completion Date

August 19, 2026

Conditions
IgA NephropathyImmunoglobulin A Nephropathy
Interventions
DRUG

Atrasentan

Period A (12 Weeks) - Film-coated tablet, Washout Period: 12 weeks, Period B (24 Weeks) - Placebo

DRUG

Atrasentan

Period B (12 Weeks) - Placebo, Washout Period: 12 weeks, Period A (24 Weeks) - Film-coated tablet

DRUG

Placebo

Placebo

Trial Locations (30)

2031

Prince of Wales Hospital, Sydney

2217

The St. George Hospital, Kogarah

3021

Sunshine Hospital, St Albans

3168

Monash Health- Monash Medical Centre, Melbourne

14068

Hallym University Sacred Heart Hospital, Anyang-si

19104

University of Pennsylvania, Philadelphia

27004

Hospital Ribera Polusa, Lugo

27599

University of North Carolina at Chapel Hill - Nephrology and Hypertension, Chapel Hill

28009

Hospital Universitario De Getafe (HUG), Madrid

28041

Hospital 12 de Octubre, Madrid

30342

Fides Clinical Research, Atlanta

30450

Hospital Raja Permaisuri Bainun (HRPB), Ipoh

31151

Soon Chun Hyang Central Medical Center (SCHMC) - Soon Chun Hyang University Hospital, Cheonan

35233

University of Alabama at Birmingham (UAB) - The Kirklin Clinic (TKC) - Nephrology Clinic, Birmingham

41009

Hospital Virgen Macarena, Seville

46010

Hospital Clinico Universitario, Valencia

49201

Dong-A University Medical Center (Dong-A University Hospital), Busan

56000

Universiti Kebangsaan Malaysia (UKM) - Medical Centre (Pusat Perubatan) (Hospital Canselor Tuanku Muhriz (HCTM)), Cheras

59100

University Malaya Medical Centre, Kuala Lumpur

60523

NANI Research, Oak Brook

80100

Hopsital Sultanah Aminah Johor Bharu (HSAJB) - Bangunan Bakawali Heodialysis Centre, Johor Bahru

02111

Tufts Medical Center, Boston

30220-140

NUPEC Cardio, Belo Horizonte

90035-074

Santa Casa de Misericordia de Porto Alegre, Porto Alegre

04038-002

Universidade Federal de Sao Paulo, São Paulo

05403-000

Hospital das Clinicas da Faculdade de Medicina da USP, São Paulo

06973

Chung-Ang University College, Seoul

04009

Hospital Torrecardenas, Almería

08003

Hospital del Mar, Barcelona

08035

Hospital del Vall d´Hebron, Barcelona

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY