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Atrasentan in Patients With IgA Nephropathy (ALIGN)

Primary Purpose

IgA Nephropathy, Immunoglobulin A Nephropathy

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atrasentan
Placebo
Sponsored by
Chinook Therapeutics U.S., Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy focused on measuring Kidney Diseases, Kidney Disease, Chronic, Urologic Diseases, Glomerulonephritis, Glomerular Disease, Glomerulonephritis, IGA, Glomerulopathy, Immunoglobulin Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Biopsy-proven IgA nephropathy.
  • Receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks. Exceptions from this requirement will be made for subjects who are unable to tolerate RAS inhibitor therapy.
  • Total urine protein ≥1 g/day as measured via 24-hour urine collection by central laboratory at Screening.
  • eGFR of at least 30 mL/min/1.73 m2 at Screening based on the CKD-EPI equation.
  • Willing and able to provide informed consent and comply with all study requirements.
  • SGLT2i Stable Stratum Only - Receiving a stable dose of an SGLT2i (per Investigator choice) in addition to a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to Screening.

Exclusion Criteria:

  • Current diagnosis with another chronic kidney disease, including diabetic kidney disease.
  • History of kidney transplantation or other organ transplantation.
  • Use of systemic immunosuppressant medications, such as steroids, for more than 2 weeks in the past 3 months.
  • Blood pressure above 150 mmHg systolic or 95 mmHg diastolic as evaluated by the Investigator.
  • Known history of heart failure or a previous hospital admission for fluid overload.
  • Clinically significant history of liver disease as assessed by the Investigator.
  • Hemoglobin below 9 g/dL as measured by the Investigator or prior history of blood transfusion for anemia within the past 3 months.
  • Malignancy within the past 5 years. Exceptions to this criteria include nonmelanoma skin cancer and curatively treated cervical carcinoma in situ.
  • For women, pregnancy, breast feeding, or intent to become pregnant during the study. and at least 1 month afterward.
  • For men, intent to father a child or donate sperm during the study.
  • Have received any investigational agent or approved treatment for IgAN (other than a RAS inhibitor) including SGLT2i (except for subjects in the SGLT2i stable stratum) within 1 month (or 5 half-lives of the agent, whichever is longer) prior to Screening. If the investigational agent is a cytotoxic or immunosuppressive agent then this washout period is 6 months.

Sites / Locations

  • University of Alabama at Birmingham
  • Nephrology Consultants, LLC
  • Comprehensive Research Institute
  • Kidney Disease Medical Group
  • Shreenath Clinical Services
  • Academic Medical Research Institute
  • UCLA Clinical and Translational Research Center
  • Chino Valley Medical Center
  • University of California San Francisco
  • Stanford University
  • University of Florida
  • DCR Columbus - Renal Associates, LLC
  • GA Nephrology Associates
  • NANI Research, LLC
  • NANI Research, LLC
  • University of Louisville Physicians- Kidney Disease Program
  • Tufts Medical Center
  • Intermed Consultants
  • Pelican Point Dialysis - DaVita Clinical Research
  • Capital District Renal Physicians
  • Mountain Kidney and Hypertension Associates
  • Brookview Hills Research Associates, LLC
  • Cincinnati VA Medical Center
  • Lehigh Valley Hospital
  • University of Pennsylvania
  • Liberty Research Center
  • Renal Disease Research Inst.
  • El Paso Kidney Specialists
  • Prolato Clinical Research Center
  • P&I Clinical Research, Llc
  • San Antonio Kidney Disease Center Physicians Group, P.L.L.C
  • Nephrology Associates Of Northern Virginia
  • Swedish Health Services
  • Milwaukee Nephrologists, SC
  • Centro Médico Ce.Re.Ca
  • CEMIC
  • Hospital Britanico de Buenos Aires
  • Centro de Investigaciones Medicas Mar del Plata
  • Clinica de Nefrologia Urologia y Enf. Cardiovasculares
  • Royal North Shore Hospital
  • Melbourne Renal Research Group
  • Sunshine Hospital
  • Box Hill Hospital
  • Royal Brisbane & Women's Hospital
  • Monash Medical Centre
  • Renal Research
  • Nepean Hospital
  • Instituto Pró-Renal Brasil
  • Hospital das Clínicas Universidade Federal de Minas Gerais - UFMG
  • Centro de Pesquisa Clinica do Brasil
  • Santa Casa de Misericordia de Porto Alegre
  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
  • Praxis Pesquisa Médica
  • Hospital das Clinicas da Faculdade de Medicina da USP
  • Hospital do Rim Fundacao Oswaldo Ramos
  • University of Alberta Hospital
  • William Osler Health System- Brampton Civic Hospital
  • London Health Sciences Centre
  • Lakeridge Health
  • Stephen S. Chow Medicine Professionals
  • Sunnybrook Health Institute
  • Montreal General Hospital
  • The First Affiliated Hospital Anhui Medical University
  • Dongguan Tungwah Hospital
  • Fujian Medical University Union Hospital
  • The First A ffliated Hospital of Baotou Medical College, Inner Mangolia University of Science and Technology
  • Jiangsu Province Hospital
  • The Affiliated Hospital of Nantong University
  • General Hospital of Ningxia Medical University
  • Renji Hospital Shanghai Jiaotong University School of Medicine
  • People's Hospital of Sichuan Province
  • The First Affiliated Hospital Xinjiang Medical University
  • Peking University First Hospital
  • Peking University People's Hospital
  • The Second Hospital of Jilin University
  • The Third Xiangya Hospital of Central South University
  • West China Hospital, Sichuan University
  • The First Affiliated Hospital of Fujian Medical University
  • Nanfang Hospital of Southern Medical University
  • The Second Hospital of Anhui Medical University
  • Shandong University - Qilu Hospital
  • The First Affiliated Hospital of Nanchang University
  • Peking University Shenzhen Hospital
  • Hospital Alma Mater de Antioquia
  • Clinica de la Costa LTDA
  • IPS Medicos Internistas de Caldas S.A.S
  • Nemocnice Novy Jicin a.s.
  • Vseobecna Fakultni Nemocnice v Praze
  • CHU de Grenoble - Hopital Albert Michallon
  • CH Emile Roux
  • Hopital Necker
  • Hôpital Européen Georges-Pompidou
  • CHU Saint Etienne - Hopital Nord
  • Centre Hospitalier Valenciennes
  • St. Josefs-Hospital
  • Medizinische Hochschule Hannover
  • Nephrologisches Zentrum Hoyerswerda
  • Universitaetsklinikum Jena
  • Klinikum St. Georg gGmbH
  • Nephrologisches Zentrum Villingen-Schwenningen
  • Universitaetsklinikum Wuerzburg
  • Princess Margaret Hospital
  • The University of Hong Kong
  • Yan Chai Hospital
  • The Chinese University of Hong Kong
  • Government Medical College
  • Sahyadri Super Speciality Hospital
  • Christian Medical College
  • Osmania General Hospital
  • Yashoda Hospital
  • Nil Ratan Sircar Medical College & Hospital
  • Cork University Hospital
  • Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico
  • Azienda Ospedaliero Universitaria San Martino
  • ICS Maugeri SpA SB
  • Istituto di Ricerche Farmacologiche Mario Negri
  • Kokura Memorial Hospital (Kokura Kinen Hospital)
  • Kanazawa Medical University
  • Kanazawa University Hospital
  • Nara University
  • St. Marianna University (SMU) School of Medicine
  • Niigata University
  • Okayama University Hospital
  • Osaka General Medical Center
  • Dokkyo Medical University - Saitama Medical Center
  • Showa University Hospital
  • Juntendo Nerima Hospital
  • Juntendo University Hospital, Tokyo
  • Fujita Health University Hospital
  • Juntendo University Urayasu Hospital
  • Hallym University Medical Center
  • Chungnam National University Hospital
  • Myongji Hospital
  • Seoul National University Bundang Hospital
  • Jeju National University Hospital
  • CHA Bundang Medical Center, CHA University
  • Korea University Anam Hospital
  • Kyung Hee University Hospital at Gangdong
  • Severance Hospital, Yonsei University Hospital
  • Dunedin Public Hospital
  • Waikato Hospital
  • Middlemore Clinical Trials
  • Centrum Medyczne Medyk - Rzeszow
  • Miedzyleski Szpital Specjalistyczny
  • Samodzielny Publiczny ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego
  • Centro Hospitalar de Lisboa Ocidental EPE - Hospital Santa Cruz
  • Centro Hospitalar do Medio Tejo (CHMT), E.P.E.
  • Fundacion Puigvert
  • Hospital Universitari Vall d'Hebron
  • Hospital Da Marina
  • Hospital General Universitario Gregorio Maranon
  • Hospital Universitario 12 De Octubre
  • Hospital de Sagunto
  • Hospital Universitario Virgen Macarena
  • H U Dr. Peset
  • Changhua Christian Medical Foundation
  • National Taiwan University Hospital Hsin-Chu Branch
  • Far Eastern Memorial Hospital
  • Taipei Medical University
  • National Taiwan University Hospital
  • North Bristol HNS Trust, Clinical Research Centre
  • Lister Hospital
  • Leicester General Hospital
  • King's College Hospital
  • Guys Hospital
  • Royal London Hospital
  • Salford Royal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atrasentan

Placebo

Arm Description

Once daily oral administration of 0.75 mg atrasentan for 132 weeks

Once daily oral administration of placebo for 132 weeks

Outcomes

Primary Outcome Measures

Change in proteinuria
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 24. (non-SGLT2i stratum)

Secondary Outcome Measures

Change in eGFR
Change from baseline to end of study in eGFR.
Percent of subjects meeting the first composite endpoint
Percent of subjects in the non-SGLT2i stratum meeting the composite endpoint of experiencing at least one of the following during the study: At least a 30% reduction in eGFR sustained for at least 30 days eGFR <15 mL/min/1.73m2, sustained for at least 30 days Chronic dialysis ≥30 days Kidney transplantation All-cause mortality
Percent of subjects meeting the second composite endpoint
Percent of subjects in the non-SGLT2i stratum meeting the composite endpoint of experiencing at least one of the following during the study: At least a 40% reduction in eGFR sustained for at least 30 days eGFR <15 mL/min/1.73m2, sustained for at least 30 days Chronic dialysis ≥30 days Kidney transplantation All-cause mortality

Full Information

First Posted
September 12, 2020
Last Updated
May 26, 2023
Sponsor
Chinook Therapeutics U.S., Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04573478
Brief Title
Atrasentan in Patients With IgA Nephropathy
Acronym
ALIGN
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chinook Therapeutics U.S., Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed Description
Approximately 320 patients with biopsy-proven IgAN will be randomized to receive 0.75 mg atrasentan or placebo daily for 132 weeks. Subjects receive a maximally tolerated and stable dose of a RAS (renin-angiotensin system) inhibitor [such as angiotensin converting enzyme inhibitor (ACEi) or angiotensin-receptor antagonist (ARB)] as part of standard of care. An exception will be made for subjects who are unable to tolerate RAS inhibitor therapy. Additional subjects receiving a stable dose of SGLT2i will be enrolled to the study. Enrollment in this SGLT2i stable stratum will be in accordance with local regulations in regions that prescribe SGLT2i and will be independent of the 320 subjects enrolled for the primary and secondary analyses. The primary objective of the study is to evaluate the effect of atrasentan versus placebo on proteinuria as measured by UPCR. Secondary and tertiary objectives include evaluating the change in kidney function over time as measured by eGFR, safety and tolerability, as well as quality of life. Subjects will have assessments of safety and efficacy over 2 ½ years. To facilitate study participation over this time period, where allowed by local regulations, options for remote study visits using telemedicine and home health may be offered. Subjects who complete the study may be eligible to enroll in an extension study to receive open-label treatment with atrasentan under a separate protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy, Immunoglobulin A Nephropathy
Keywords
Kidney Diseases, Kidney Disease, Chronic, Urologic Diseases, Glomerulonephritis, Glomerular Disease, Glomerulonephritis, IGA, Glomerulopathy, Immunoglobulin Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atrasentan
Arm Type
Experimental
Arm Description
Once daily oral administration of 0.75 mg atrasentan for 132 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Once daily oral administration of placebo for 132 weeks
Intervention Type
Drug
Intervention Name(s)
Atrasentan
Other Intervention Name(s)
CHK-01, Atrasentan Hydrochloride, ABT-627
Intervention Description
Film-coated tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Film-coated tablet
Primary Outcome Measure Information:
Title
Change in proteinuria
Description
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 24. (non-SGLT2i stratum)
Time Frame
Up to Week 24 or approximately 6 months
Secondary Outcome Measure Information:
Title
Change in eGFR
Description
Change from baseline to end of study in eGFR.
Time Frame
Up to approximately 2.6 years
Title
Percent of subjects meeting the first composite endpoint
Description
Percent of subjects in the non-SGLT2i stratum meeting the composite endpoint of experiencing at least one of the following during the study: At least a 30% reduction in eGFR sustained for at least 30 days eGFR <15 mL/min/1.73m2, sustained for at least 30 days Chronic dialysis ≥30 days Kidney transplantation All-cause mortality
Time Frame
Up to approximately 2.6 years
Title
Percent of subjects meeting the second composite endpoint
Description
Percent of subjects in the non-SGLT2i stratum meeting the composite endpoint of experiencing at least one of the following during the study: At least a 40% reduction in eGFR sustained for at least 30 days eGFR <15 mL/min/1.73m2, sustained for at least 30 days Chronic dialysis ≥30 days Kidney transplantation All-cause mortality
Time Frame
Up to approximately 2.6 years
Other Pre-specified Outcome Measures:
Title
Change in proteinuria (UPCR)
Description
1. Change in proteinuria (UPCR) based on 24-hour urine collection in SGLT2i stable stratum compared to Placebo
Time Frame
Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Biopsy-proven IgA nephropathy. Receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks. Exceptions from this requirement will be made for subjects who are unable to tolerate RAS inhibitor therapy. Total urine protein ≥1 g/day as measured via 24-hour urine collection by central laboratory at Screening. eGFR of at least 30 mL/min/1.73 m2 at Screening based on the CKD-EPI equation. Willing and able to provide informed consent and comply with all study requirements. SGLT2i Stable Stratum Only - Receiving a stable dose of an SGLT2i (per Investigator choice) in addition to a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to Screening. Exclusion Criteria: Current diagnosis with another chronic kidney disease, including diabetic kidney disease. History of kidney transplantation or other organ transplantation. Use of systemic immunosuppressant medications, such as steroids, for more than 2 weeks in the past 3 months. Blood pressure above 150 mmHg systolic or 95 mmHg diastolic as evaluated by the Investigator. Known history of heart failure or a previous hospital admission for fluid overload. Clinically significant history of liver disease as assessed by the Investigator. Hemoglobin below 9 g/dL as measured by the Investigator or prior history of blood transfusion for anemia within the past 3 months. Malignancy within the past 5 years. Exceptions to this criteria include nonmelanoma skin cancer and curatively treated cervical carcinoma in situ. For women, pregnancy, breast feeding, or intent to become pregnant during the study. and at least 1 month afterward. For men, intent to father a child or donate sperm during the study. Have received any investigational agent or approved treatment for IgAN (other than a RAS inhibitor) including SGLT2i (except for subjects in the SGLT2i stable stratum) within 1 month (or 5 half-lives of the agent, whichever is longer) prior to Screening. If the investigational agent is a cytotoxic or immunosuppressive agent then this washout period is 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte Jones-Burton, MD, MS
Organizational Affiliation
SVP, Product Development & Strategy
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Nephrology Consultants, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
Comprehensive Research Institute
City
Alhambra
State/Province
California
ZIP/Postal Code
91754
Country
United States
Facility Name
Kidney Disease Medical Group
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Shreenath Clinical Services
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Academic Medical Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
UCLA Clinical and Translational Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Chino Valley Medical Center
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
93405
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
DCR Columbus - Renal Associates, LLC
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
GA Nephrology Associates
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
NANI Research, LLC
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
NANI Research, LLC
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
University of Louisville Physicians- Kidney Disease Program
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Intermed Consultants
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Pelican Point Dialysis - DaVita Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89129
Country
United States
Facility Name
Capital District Renal Physicians
City
Clifton Park
State/Province
New York
ZIP/Postal Code
12065
Country
United States
Facility Name
Mountain Kidney and Hypertension Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Brookview Hills Research Associates, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Cincinnati VA Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Lehigh Valley Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Liberty Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Renal Disease Research Inst.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
El Paso Kidney Specialists
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925
Country
United States
Facility Name
Prolato Clinical Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
P&I Clinical Research, Llc
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Facility Name
San Antonio Kidney Disease Center Physicians Group, P.L.L.C
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Nephrology Associates Of Northern Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22033
Country
United States
Facility Name
Swedish Health Services
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Milwaukee Nephrologists, SC
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Centro Médico Ce.Re.Ca
City
Ciudad De San Luis
State/Province
San Luis
ZIP/Postal Code
D5700CGR
Country
Argentina
Facility Name
CEMIC
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires
City
Buenos Aires
Country
Argentina
Facility Name
Centro de Investigaciones Medicas Mar del Plata
City
Mar Del Plata
Country
Argentina
Facility Name
Clinica de Nefrologia Urologia y Enf. Cardiovasculares
City
Santa Fe
Country
Argentina
Facility Name
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Melbourne Renal Research Group
City
Reservoir
State/Province
Victoria
ZIP/Postal Code
3073
Country
Australia
Facility Name
Sunshine Hospital
City
Saint Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
Country
Australia
Facility Name
Royal Brisbane & Women's Hospital
City
Brisbane
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
Country
Australia
Facility Name
Renal Research
City
Gosford
Country
Australia
Facility Name
Nepean Hospital
City
Kingswood
Country
Australia
Facility Name
Instituto Pró-Renal Brasil
City
Curitiba
State/Province
Paraná
Country
Brazil
Facility Name
Hospital das Clínicas Universidade Federal de Minas Gerais - UFMG
City
Belo Horizonte
Country
Brazil
Facility Name
Centro de Pesquisa Clinica do Brasil
City
Brasília
Country
Brazil
Facility Name
Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
Country
Brazil
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
City
Rio Preto
Country
Brazil
Facility Name
Praxis Pesquisa Médica
City
Santo André
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina da USP
City
São Paulo
Country
Brazil
Facility Name
Hospital do Rim Fundacao Oswaldo Ramos
City
São Paulo
Country
Brazil
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
William Osler Health System- Brampton Civic Hospital
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
Facility Name
Lakeridge Health
City
Oshawa
State/Province
Ontario
Country
Canada
Facility Name
Stephen S. Chow Medicine Professionals
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Health Institute
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Montreal General Hospital
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
The First Affiliated Hospital Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Dongguan Tungwah Hospital
City
Dongguan
State/Province
Dongguan
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
The First A ffliated Hospital of Baotou Medical College, Inner Mangolia University of Science and Technology
City
Baotou
State/Province
Inner Mongolia Autonomou
ZIP/Postal Code
014010
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Facility Name
Renji Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
People's Hospital of Sichuan Province
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Facility Name
The First Affiliated Hospital Xinjiang Medical University
City
Ürümqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
The Second Hospital of Jilin University
City
Changchun
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
Country
China
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
Country
China
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
ZIP/Postal Code
230601
Country
China
Facility Name
Shandong University - Qilu Hospital
City
Jinan
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
ZIP/Postal Code
518036
Country
China
Facility Name
Hospital Alma Mater de Antioquia
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
050010
Country
Colombia
Facility Name
Clinica de la Costa LTDA
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
IPS Medicos Internistas de Caldas S.A.S
City
Manizales
State/Province
Caldas
ZIP/Postal Code
170004
Country
Colombia
Facility Name
Nemocnice Novy Jicin a.s.
City
Nový Jičín
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
Vseobecna Fakultni Nemocnice v Praze
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
CHU de Grenoble - Hopital Albert Michallon
City
Grenoble
Country
France
Facility Name
CH Emile Roux
City
Le Puy-en-Velay
Country
France
Facility Name
Hopital Necker
City
Paris
Country
France
Facility Name
Hôpital Européen Georges-Pompidou
City
Paris
Country
France
Facility Name
CHU Saint Etienne - Hopital Nord
City
Saint-Priest-en-Jarez
Country
France
Facility Name
Centre Hospitalier Valenciennes
City
Valenciennes
Country
France
Facility Name
St. Josefs-Hospital
City
Cloppenburg
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Nephrologisches Zentrum Hoyerswerda
City
Hoyerswerda
Country
Germany
Facility Name
Universitaetsklinikum Jena
City
Jena
Country
Germany
Facility Name
Klinikum St. Georg gGmbH
City
Leipzig
Country
Germany
Facility Name
Nephrologisches Zentrum Villingen-Schwenningen
City
Villingen-Schwenningen
Country
Germany
Facility Name
Universitaetsklinikum Wuerzburg
City
Würzburg
Country
Germany
Facility Name
Princess Margaret Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
Yan Chai Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
The Chinese University of Hong Kong
City
Shatin
Country
Hong Kong
Facility Name
Government Medical College
City
Kozhikode
State/Province
Kerala
ZIP/Postal Code
673008
Country
India
Facility Name
Sahyadri Super Speciality Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Christian Medical College
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632004
Country
India
Facility Name
Osmania General Hospital
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500012
Country
India
Facility Name
Yashoda Hospital
City
Secunderabad
State/Province
Telangana
ZIP/Postal Code
500003
Country
India
Facility Name
Nil Ratan Sircar Medical College & Hospital
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700014
Country
India
Facility Name
Cork University Hospital
City
Cork
ZIP/Postal Code
T12 DC4A
Country
Ireland
Facility Name
Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria San Martino
City
Genova
Country
Italy
Facility Name
ICS Maugeri SpA SB
City
Pavia
Country
Italy
Facility Name
Istituto di Ricerche Farmacologiche Mario Negri
City
Ranica
Country
Italy
Facility Name
Kokura Memorial Hospital (Kokura Kinen Hospital)
City
Fukuoka
Country
Japan
Facility Name
Kanazawa Medical University
City
Kahoku
Country
Japan
Facility Name
Kanazawa University Hospital
City
Kanazawa
Country
Japan
Facility Name
Nara University
City
Kashihara
Country
Japan
Facility Name
St. Marianna University (SMU) School of Medicine
City
Kawasaki
Country
Japan
Facility Name
Niigata University
City
Niigata
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka
Country
Japan
Facility Name
Dokkyo Medical University - Saitama Medical Center
City
Saitama
Country
Japan
Facility Name
Showa University Hospital
City
Shinagawa-ku
Country
Japan
Facility Name
Juntendo Nerima Hospital
City
Tokyo
Country
Japan
Facility Name
Juntendo University Hospital, Tokyo
City
Tokyo
Country
Japan
Facility Name
Fujita Health University Hospital
City
Toyoake
Country
Japan
Facility Name
Juntendo University Urayasu Hospital
City
Urayasu
Country
Japan
Facility Name
Hallym University Medical Center
City
Anyang
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Myongji Hospital
City
Gyeonggi-do
ZIP/Postal Code
10475
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Jeju National University Hospital
City
Jeju
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center, CHA University
City
Seongnam-si
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Dunedin Public Hospital
City
Dunedin
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
Country
New Zealand
Facility Name
Middlemore Clinical Trials
City
Papatoetoe
Country
New Zealand
Facility Name
Centrum Medyczne Medyk - Rzeszow
City
Rzeszów
Country
Poland
Facility Name
Miedzyleski Szpital Specjalistyczny
City
Warszawa
Country
Poland
Facility Name
Samodzielny Publiczny ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego
City
Łódź
Country
Poland
Facility Name
Centro Hospitalar de Lisboa Ocidental EPE - Hospital Santa Cruz
City
Carnaxide
ZIP/Postal Code
2790-134
Country
Portugal
Facility Name
Centro Hospitalar do Medio Tejo (CHMT), E.P.E.
City
Torres Novas
ZIP/Postal Code
2350-399
Country
Portugal
Facility Name
Fundacion Puigvert
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Da Marina
City
Lugo
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
Country
Spain
Facility Name
Hospital Universitario 12 De Octubre
City
Madrid
Country
Spain
Facility Name
Hospital de Sagunto
City
Sagunto
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
Country
Spain
Facility Name
H U Dr. Peset
City
Valencia
Country
Spain
Facility Name
Changhua Christian Medical Foundation
City
Changhua
Country
Taiwan
Facility Name
National Taiwan University Hospital Hsin-Chu Branch
City
Hsinchu
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
Country
Taiwan
Facility Name
Taipei Medical University
City
New Taipei City
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
North Bristol HNS Trust, Clinical Research Centre
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Lister Hospital
City
Hertford
Country
United Kingdom
Facility Name
Leicester General Hospital
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9R6
Country
United Kingdom
Facility Name
Guys Hospital
City
London
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
Country
United Kingdom
Facility Name
Salford Royal
City
Salford
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Atrasentan in Patients With IgA Nephropathy

We'll reach out to this number within 24 hrs