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ACTIVE NOT RECRUITING
NCT04573478
PHASE3

Atrasentan in Patients With IgA Nephropathy

Sponsor: Chinook Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal function.

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal Function

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

404

Start Date

2020-12-11

Completion Date

2026-12-18

Last Updated

2024-10-15

Healthy Volunteers

No

Interventions

DRUG

Atrasentan

Film-coated tablet

DRUG

Placebo

Film-coated tablet

Locations (135)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Comprehensive Research Institute

Alhambra, California, United States

Kidney Disease Medical Group

Glendale, California, United States

Stanford University

Stanford, California, United States

University of Florida

Gainesville, Florida, United States

GA Nephrology Associates

Lawrenceville, Georgia, United States

NANI Research, LLC

Hinsdale, Illinois, United States

NANI Research, LLC

Fort Wayne, Indiana, United States

University of Louisville Physicians- Kidney Disease Program

Louisville, Kentucky, United States

Tufts Medical Center

Boston, Massachusetts, United States

Intermed Consultants

Minneapolis, Minnesota, United States

Pelican Point Dialysis - DaVita Clinical Research

Las Vegas, Nevada, United States

Capital District Renal Physicians

Clifton Park, New York, United States

Mountain Kidney and Hypertension Associates

Asheville, North Carolina, United States

Brookview Hills Research Associates, LLC

Winston-Salem, North Carolina, United States

Lehigh Valley Hospital

Bethlehem, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Liberty Research Center

Dallas, Texas, United States

El Paso Kidney Specialists

El Paso, Texas, United States

Nephrology Associates Of Northern Virginia

Fairfax, Virginia, United States

Swedish Health Services

Seattle, Washington, United States

Centro Médico Ce.Re.Ca

San Luis, San Luis Province, Argentina

CEMIC

Buenos Aires, Argentina

Hospital Britanico de Buenos Aires

Buenos Aires, Argentina

Clinica de Nefrologia Urologia y Enf. Cardiovasculares

Santa Fe, Argentina

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Melbourne Renal Research Group

Reservoir, Victoria, Australia

Sunshine Hospital

Saint Albans, Victoria, Australia

Box Hill Hospital

Box Hill, Australia

Royal Brisbane & Women's Hospital

Brisbane, Australia

Monash Medical Centre

Clayton, Australia

Renal Research

Gosford, Australia

Nepean Hospital

Kingswood, Australia

Instituto Pró-Renal Brasil

Curitiba, Paraná, Brazil

Hospital das Clínicas Universidade Federal de Minas Gerais - UFMG

Belo Horizonte, Brazil

Centro de Pesquisa Clinica do Brasil

Brasília, Brazil

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

Praxis Pesquisa Médica

Santo André, Brazil

Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, Brazil

Hospital do Rim Fundacao Oswaldo Ramos

São Paulo, Brazil

London Health Sciences Centre

London, Ontario, Canada

Stephen S. Chow Medicine Professionals

Toronto, Ontario, Canada

Dongguan Tungwah Hospital

Dongguan, Dongguan, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

The First A ffliated Hospital of Baotou Medical College, Inner Mangolia University of Science and Technology

Baotou, Inner Mongolia Autonomou, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

People's Hospital of Sichuan Province

Chengdu, Sichuan, China

The First Affiliated Hospital Xinjiang Medical University

Ürümqi, Xinjiang Uygur, China

Peking University First Hospital

Beijing, China

Peking University People's Hospital

Beijing, China

The Second Hospital of Jilin University

Changchun, China

The Third Xiangya Hospital of Central South University

Changsha, China

West China Hospital, Sichuan University

Chengdu, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, China

Nanfang Hospital of Southern Medical University

Guangzhou, China

The Second Hospital of Anhui Medical University

Hefei, China

Shandong University - Qilu Hospital

Jinan, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

Peking University Shenzhen Hospital

Shenzhen, China

Hospital Alma Mater de Antioquia

Medellín, Antioquia, Colombia

IPS Medicos Internistas de Caldas S.A.S

Manizales, Caldas Department, Colombia

CHU de Grenoble - Hopital Albert Michallon

Grenoble, France

CH Emile Roux

Le Puy-en-Velay, France

Hopital Necker

Paris, France

CHU Saint Etienne - Hopital Nord

Saint-Priest-en-Jarez, France

Centre Hospitalier Valenciennes

Valenciennes, France

St. Josefs-Hospital

Cloppenburg, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Nephrologisches Zentrum Hoyerswerda

Hoyerswerda, Germany

Universitaetsklinikum Jena

Jena, Germany

Nephrologisches Zentrum Villingen-Schwenningen

Villingen-Schwenningen, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Princess Margaret Hospital

Hong Kong, Hong Kong

The University of Hong Kong

Hong Kong, Hong Kong

Yan Chai Hospital

Hong Kong, Hong Kong

The Chinese University of Hong Kong

Shatin, Hong Kong

Government Medical College

Kozhikode, Kerala, India

Sahyadri Super Speciality Hospital

Pune, Maharashtra, India

Christian Medical College

Vellore, Tamil Nadu, India

Osmania General Hospital

Hyderabad, Telangana, India

Yashoda Hospital

Secunderabad, Telangana, India

Nil Ratan Sircar Medical College & Hospital

Kolkata, West Bengal, India

Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

Azienda Ospedaliero Universitaria San Martino

Genova, Italy

Seconda Università degli Studi di Napoli

Naples, Italy

ICS Maugeri SpA SB

Pavia, Italy

Kokura Memorial Hospital (Kokura Kinen Hospital)

Fukuoka, Japan

Kanazawa University Hospital

Kanazawa, Japan

Nara University

Kashihara, Japan

St. Marianna University (SMU) School of Medicine

Kawasaki, Japan

Niigata University

Niigata, Japan

Okayama University Hospital

Okayama, Japan

Osaka General Medical Center

Osaka, Japan

Dokkyo Medical University - Saitama Medical Center

Saitama, Japan

Showa University Hospital

Shinagawa-ku, Japan

Juntendo Nerima Hospital

Tokyo, Japan

Juntendo University Hospital, Tokyo

Tokyo, Japan

Fujita Health University Hospital

Toyoake, Japan

Juntendo University Urayasu Hospital

Urayasu, Japan

Waikato Hospital

Hamilton, New Zealand

Middlemore Clinical Trials

Papatoetoe, New Zealand

Samodzielny Publiczny ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego

Lodz, Poland

Centrum Medyczne Medyk - Rzeszow

Rzeszów, Poland

Miedzyleski Szpital Specjalistyczny

Warsaw, Poland

Centro Hospitalar de Lisboa Ocidental EPE - Hospital Santa Cruz

Carnaxide, Portugal

Centro Hospitalar do Medio Tejo (CHMT), E.P.E.

Torres Novas, Portugal

Hallym University Medical Center

Anyang, South Korea

Chungnam National University Hospital

Daejeon, South Korea

Myongji Hospital

Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Jeju National University Hospital

Jeju City, South Korea

CHA Bundang Medical Center, CHA University

Seongnam-si, South Korea

Korea University Anam Hospital

Seoul, South Korea

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Severance Hospital, Yonsei University Hospital

Seoul, South Korea

Fundacion Puigvert

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario 12 De Octubre

Madrid, Spain

Hospital de Sagunto

Sagunto, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

H U Dr. Peset

Valencia, Spain

Changhua Christian Medical Foundation

Changhua, Taiwan

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Taipei Medical University

New Taipei City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

North Bristol HNS Trust, Clinical Research Centre

Bristol, United Kingdom

Lister Hospital

Hertford, United Kingdom

Leicester General Hospital

Leicester, United Kingdom

King's College Hospital

London, United Kingdom

Guys Hospital

London, United Kingdom

Royal London Hospital

London, United Kingdom

Salford Royal

Salford, United Kingdom