Clinical Research Directory
Browse clinical research sites, groups, and studies.
Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy
Sponsor: Novartis Pharmaceuticals
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
Atrasentan
Period A (12 Weeks) - Film-coated tablet, Washout Period: 12 weeks, Period B (24 Weeks) - Placebo
Atrasentan
Period B (12 Weeks) - Placebo, Washout Period: 12 weeks, Period A (24 Weeks) - Film-coated tablet
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