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COMPLETED
NCT05834738
PHASE2

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The ASSIST study was a phase 2, double-blind, placebo-controlled crossover study to evaluate the safety and efficacy of atrasentan vs. placebo in subjects with IgA nephropathy (IgAN) while on background standard of care therapy and an SGLT2 inhibitor (SGLT2i).

Official title: A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy on Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2023-07-20

Completion Date

2025-10-29

Last Updated

2026-07-20

Healthy Volunteers

No

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

Locations (30)

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

Birmingham, Alabama, United States

Fides Clinical Research

Atlanta, Georgia, United States

NANI Research

Oak Brook, Illinois, United States

Tufts Medical Center

Boston, Massachusetts, United States

University of North Carolina at Chapel Hill - Nephrology and Hypertension

Chapel Hill, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

The St. George Hospital

Kogarah, New South Wales, Australia

Prince of Wales Hospital

Sydney, New South Wales, Australia

Monash Health- Monash Medical Centre

Melbourne, Victoria, Australia

Sunshine Hospital

St Albans, Victoria, Australia

NUPEC Cardio

Belo Horizonte, Minas Gerais, Brazil

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Universidade Federal de Sao Paulo

São Paulo, São Paulo, Brazil

Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, São Paulo, Brazil

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

Johor Bahru, Johor Darul Takzim, Malaysia

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

Cheras, Kuala Lumpur, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Hospital Raja Permaisuri Bainun (HRPB)

Ipoh, Perak, Malaysia

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

Busan, Busan, South Korea

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

Cheonan, Chungnam-Do, South Korea

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Chung-Ang University College

Seoul, Seoul, South Korea

Hospital Torrecardenas

Almería, Spain

Hospital del Mar

Barcelona, Spain

Hospital del Vall d´Hebron

Barcelona, Spain

Hospital Ribera Polusa

Lugo, Spain

Hospital Universitario De Getafe (HUG)

Madrid, Spain

Hospital 12 de Octubre

Madrid, Spain

Hospital Virgen Macarena

Seville, Spain

Hospital Clinico Universitario

Valencia, Spain