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Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)

Primary Purpose

Anemia, Dialysis-Dependent Chronic Kidney Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Vadadustat

Darbepoetin alfa

About this trial

This is an interventional treatment trial for Anemia focused on measuring AKB-6548, Chronic kidney disease, anemia, CKD, chronic renal insufficiency, renal impairment, erythropoietin, kidney, renal, oral anemia treatment, hemoglobin, hypoxia-inducible factor, HIF, hypoxia-inducible factor prolyl-hydroxylase inhibitor, HIF-PHI, efficacy, safety, Phase 3, cardiovascular, DD-CKD

Eligibility Criteria

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

Inclusion Criteria:

≥18 years of age
Receiving chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease for at least 12 weeks prior to Screening
Currently maintained on erythropoiesis-stimulating agent therapy, with a dose received within 6 weeks prior to or during Screening
Mean Screening hemoglobin between 8.0 and 11.0 grams per deciliter (g/dL) (inclusive) in the US and between 9.0 and 12.0 g/dL (inclusive) outside of the US
Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening

Exclusion Criteria:

Anemia due to a cause other than chronic kidney disease or participants with active bleeding or recent blood loss
Uncontrolled hypertension
Red blood cell transfusion within 8 weeks prior to randomization
Anticipated to recover adequate kidney function to no longer require dialysis
Severe heart failure at Screening (New York Heart Association Class IV)
Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure, or stroke within 12 weeks prior to or during Screening
Hypersensitivity to Vadadustat, Darbepoetin alfa, or any of their excipients

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vadadustat

Darbepoetin alfa

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)

The Baseline average was calculated as the average of the Hb values obtained at the screening visit closest to the date of randomization and the randomization visit. The average for the Primary Efficacy Period was calculated as the average Hb value over Weeks 24 to 36. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with Baseline hemoglobin concentration (<10.0 versus ≥10.0 g/dL), geographic region (United States [US] versus European Union [EU] versus Rest of World [ROW]), and New York Heart Association congestive heart failure (NYHA CHF) class (Class 0 [no CHF] or I versus II or III) as covariates.

Median Time to First Major Adverse Cardiovascular Event (MACE)

MACE was defined as all-cause mortality, non-fatal myocardial infarction (MI), or non-fatal stroke. The primary safety outcome was positively adjudicated first MACE, which was defined as any death, Endpoint Adjudication Committee (EAC)-confirmed non-fatal MI, or EAC-confirmed non-fatal stroke occurring between the first dose date and each participant's last participation date. INNOVATE MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Results and statistical analysis from study AKB-6548-CI-0017 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0016 and AKB-6548-CI-0017 has been reported under section "Statistical Analysis 2" of this outcome measure.

Secondary Outcome Measures

Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52)

The Baseline average was calculated as the average of the Hb values obtained at the screening visit closest to the date of randomization and the randomization visit. The average for the Secondary Efficacy Period was calculated as the average Hb value over Weeks 40 to 52. Analysis was conducted using an ANCOVA model with multiple imputation for missing data with Baseline hemoglobin concentration (<10.0 versus ≥10.0 g/dL), geographic region (US versus EU versus ROW), and NYHA CHF class (Class 0 [no CHF] or I versus II or III) as covariates.

Median Time to First MACE Plus Hospitalization for Heart Failure or Thromboembolic Event Excluding Vascular Access Thrombosis

MACE was defined as all-cause mortality, non-fatal MI, or non-fatal stroke. Hospitalization for EAC adjudicated heart failure included presentation of participants to an acute care facility requiring an overnight hospitalization (change in calendar day) with an exacerbation of heart failure requiring treatment. EAC confirmed thromboembolic events for this secondary outcome measure included arterial thrombosis, deep vein thrombosis, and pulmonary embolism. INNOVATE MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Results and statistical analysis from study AKB-6548-CI-0017 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0016 and AKB-6548-CI-0017 has been reported under section "Statistical Analysis 2" of this outcome measure.

Median Time to First Cardiovascular MACE

MACE was defined as all-cause mortality, non-fatal MI, or non-fatal stroke. Cardiovascular MACE analysis differed from the primary MACE endpoint as it included only deaths adjudicated by the EAC as cardiovascular deaths (i.e, only EAC-confirmed cardiovascular deaths) in addition to first events of non-fatal MI or non-fatal stroke. INNOVATE MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Results and statistical analysis from study AKB-6548-CI-0017 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0016 and AKB-6548-CI-0017 has been reported under section "Statistical Analysis 2" of this outcome measure.

Median Time to First Cardiovascular Death

Cardiovascular death included EAC adjudicated fatal MI, pump failure, sudden death, presumed sudden death, fatal stroke, fatal pulmonary embolism, cardiovascular procedure-related death, other cardiovascular death, and presumed cardiovascular death. INNOVATE MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Results and statistical analysis from study AKB-6548-CI-0017 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0016 and AKB-6548-CI-0017 has been reported under section "Statistical Analysis 2" of this outcome measure.

Median Time to First All-cause Mortality

Only events that were positively adjudicated and confirmed by the EAC were included in the MACE analyses. INNOVATE MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Results and statistical analysis from study AKB-6548-CI-0017 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0016 and AKB-6548-CI-0017 has been reported under section "Statistical Analysis 2" of this outcome measure.

Full Information

NCT ID

NCT02892149

First Posted

September 2, 2016

Last Updated

June 7, 2022

Sponsor

Akebia Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT02892149

Brief Title

Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)

Official Title

Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE-CONVERSION)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

August 2016 (Actual)

Primary Completion Date

January 16, 2020 (Actual)

Study Completion Date

March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Akebia Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with dialysis-dependent chronic kidney disease (DD-CKD)

Detailed Description

This is a multicenter, randomized, open-label, active-controlled Phase 3 study of the efficacy and safety of Vadadustat versus Darbepoetin alfa for the maintenance treatment of anemia in participants with DD-CKD

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, Dialysis-Dependent Chronic Kidney Disease

Keywords

AKB-6548, Chronic kidney disease, anemia, CKD, chronic renal insufficiency, renal impairment, erythropoietin, kidney, renal, oral anemia treatment, hemoglobin, hypoxia-inducible factor, HIF, hypoxia-inducible factor prolyl-hydroxylase inhibitor, HIF-PHI, efficacy, safety, Phase 3, cardiovascular, DD-CKD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Masking Description

Sponsor was blinded during the study

Allocation

Randomized

Enrollment

3554 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vadadustat

Arm Type

Experimental

Arm Title

Darbepoetin alfa

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Vadadustat

Other Intervention Name(s)

AKB-6548

Intervention Description

Oral dose administered once daily for ≥36 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.

Intervention Type

Drug

Intervention Name(s)

Darbepoetin alfa

Other Intervention Name(s)

Aranesp

Intervention Description

Subcutaneous or intravenous dose administered for ≥36 weeks. Initial dose based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.

Primary Outcome Measure Information:

Title

Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)

Description

Time Frame

Baseline; Weeks 24 to 36

Title

Median Time to First Major Adverse Cardiovascular Event (MACE)

Description

Time Frame

Up to 170 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52)

Description

The Baseline average was calculated as the average of the Hb values obtained at the screening visit closest to the date of randomization and the randomization visit. The average for the Secondary Efficacy Period was calculated as the average Hb value over Weeks 40 to 52. Analysis was conducted using an ANCOVA model with multiple imputation for missing data with Baseline hemoglobin concentration (<10.0 versus ≥10.0 g/dL), geographic region (US versus EU versus ROW), and NYHA CHF class (Class 0 [no CHF] or I versus II or III) as covariates.

Time Frame

Baseline; Weeks 40 to 52

Title

Median Time to First MACE Plus Hospitalization for Heart Failure or Thromboembolic Event Excluding Vascular Access Thrombosis

Description

Time Frame

Up to 170 weeks

Title

Median Time to First Cardiovascular MACE

Description

Time Frame

Up to 170 weeks

Title

Median Time to First Cardiovascular Death

Description

Time Frame

Up to 170 weeks

Title

Median Time to First All-cause Mortality

Description

Time Frame

Up to 170 weeks

Other Pre-specified Outcome Measures:

Title

Exploratory - Proportion of Participants With Hb Values Within the Target Range During the Primary Evaluation Period (Weeks 24 to 36)

Time Frame

Weeks 24 to 36

Title

Exploratory - Proportion of Time With Hb Values Within the Target Range During the Primary Evaluation Period (Weeks 24 to 36)

Time Frame

Weeks 24 to 36

Title

Exploratory - Proportion of Time With Hb Values Within the Target Range During the Secondary Evaluation Period (Weeks 40 to 52)

Time Frame

Weeks 40 to 52

Title

Exploratory - Proportion of Participants With Hb Values Within the Target Range During the Secondary Evaluation Period (Weeks 40 to 52)

Time Frame

Weeks 40 to 52

Title

Exploratory - Proportion of Participants With an Hb Increase of >1.0 g/dL From Baseline Visit

Time Frame

Baseline; up to Week 52

Title

Exploratory - Time to Achieve Hb Increase of >1.0 g/dL From Baseline Visit

Time Frame

Baseline; up to Week 52

Title

Exploratory - Mean Change in Hb Between Baseline (Mean Pretreatment Hb) and the Primary Evaluation Period (Mean Hb From Weeks 24 to 36) Stratified by Pre-baseline Erythropoiesis-stimulating Agent (ESA) Exposure

Time Frame

Baseline; Weeks 24 to 36

Title

Exploratory - Mean Monthly Dose of Intravenous (IV) Elemental Iron Administered in Participants Who Have Received IV Iron

Time Frame

Up to Week 52

Title

Exploratory - Proportion of Participants Receiving IV Iron Therapy

Time Frame

Up to Week 52

Title

Exploratory - Proportion of Participants Receiving Red Blood Cells (RBCs) Transfusion(s)

Time Frame

Up to Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ≥18 years of age Receiving chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease for at least 12 weeks prior to Screening Currently maintained on erythropoiesis-stimulating agent therapy, with a dose received within 6 weeks prior to or during Screening Mean Screening hemoglobin between 8.0 and 11.0 grams per deciliter (g/dL) (inclusive) in the US and between 9.0 and 12.0 g/dL (inclusive) outside of the US Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening Exclusion Criteria: Anemia due to a cause other than chronic kidney disease or participants with active bleeding or recent blood loss Uncontrolled hypertension Red blood cell transfusion within 8 weeks prior to randomization Anticipated to recover adequate kidney function to no longer require dialysis Severe heart failure at Screening (New York Heart Association Class IV) Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure, or stroke within 12 weeks prior to or during Screening Hypersensitivity to Vadadustat, Darbepoetin alfa, or any of their excipients

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chief Medical Officer

Organizational Affiliation

Akebia Therapeutics Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35805

Country

United States

Facility Name

Research Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85210

Country

United States

Facility Name

Research Site

City

Pine Bluff

State/Province

Arkansas

ZIP/Postal Code

71603

Country

United States

Facility Name

Research Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Research Site #1

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Research Site #2

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Research Site

City

Canyon Country

State/Province

California

ZIP/Postal Code

91387

Country

United States

Facility Name

Research Site

City

Chula Vista

State/Province

California

ZIP/Postal Code

91910

Country

United States

Facility Name

Research Site

City

Downey

State/Province

California

ZIP/Postal Code

90240

Country

United States

Facility Name

Research Site

City

El Centro

State/Province

California

ZIP/Postal Code

92243

Country

United States

Facility Name

Research Site

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

Research Site

City

Fairfield

State/Province

California

ZIP/Postal Code

94534

Country

United States

Facility Name

Research Site

City

Glendale

State/Province

California

ZIP/Postal Code

91206

Country

United States

Facility Name

Research Site #1

City

Granada Hills

State/Province

California

ZIP/Postal Code

91344

Country

United States

Facility Name

Research Site #2

City

Granada Hills

State/Province

California

ZIP/Postal Code

91344

Country

United States

Facility Name

Research Site

City

La Habra

State/Province

California

ZIP/Postal Code

90631

Country

United States

Facility Name

Research Site

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Research Site

City

Lakewood

State/Province

California

ZIP/Postal Code

90712-2512

Country

United States

Facility Name

Research Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90807

Country

United States

Facility Name

Research Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90813

Country

United States

Facility Name

Research Site

City

Long Beach

State/Province

California

ZIP/Postal Code

92886

Country

United States

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90022

Country

United States

Facility Name

Research Site #1

City

Montebello

State/Province

California

ZIP/Postal Code

90640

Country

United States

Facility Name

Research Site

City

Monterey Park

State/Province

California

ZIP/Postal Code

91754

Country

United States

Facility Name

Research Site

City

Newhall

State/Province

California

ZIP/Postal Code

91321

Country

United States

Facility Name

Research Site #1

City

Northridge

State/Province

California

ZIP/Postal Code

91324

Country

United States

Facility Name

Research Site #2

City

Northridge

State/Province

California

ZIP/Postal Code

91324

Country

United States

Facility Name

Research Site

City

Riverside

State/Province

California

ZIP/Postal Code

92503

Country

United States

Facility Name

Research Site

City

Riverside

State/Province

California

ZIP/Postal Code

92505

Country

United States

Facility Name

Research Site

City

Roseville

State/Province

California

ZIP/Postal Code

95661

Country

United States

Facility Name

Research Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95825

Country

United States

Facility Name

Research Site

City

San Diego

State/Province

California

ZIP/Postal Code

92111

Country

United States

Facility Name

Research Site

City

San Diego

State/Province

California

ZIP/Postal Code

92115

Country

United States

Facility Name

Research Site #1

City

San Dimas

State/Province

California

ZIP/Postal Code

91773

Country

United States

Facility Name

Research Site #2

City

San Dimas

State/Province

California

ZIP/Postal Code

91773

Country

United States

Facility Name

Research Site

City

Simi Valley

State/Province

California

ZIP/Postal Code

93065

Country

United States

Facility Name

Research Site

City

Tarzana

State/Province

California

ZIP/Postal Code

91356

Country

United States

Facility Name

Research Site

City

Whittier

State/Province

California

ZIP/Postal Code

90603

Country

United States

Facility Name

Research Site

City

Whittier

State/Province

California

ZIP/Postal Code

90606

Country

United States

Facility Name

Research Site

City

Arvada

State/Province

Colorado

ZIP/Postal Code

80002

Country

United States

Facility Name

Research Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Research Site

City

Westminster

State/Province

Colorado

ZIP/Postal Code

80031

Country

United States

Facility Name

Research Site

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06902

Country

United States

Facility Name

Research Site

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34209

Country

United States

Facility Name

Research Site

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Research Site

City

Coral Springs

State/Province

Florida

ZIP/Postal Code

33065

Country

United States

Facility Name

Research Site

City

Coral Springs

State/Province

Florida

ZIP/Postal Code

33071

Country

United States

Facility Name

Research Site

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

Research Site #1

City

Lauderdale Lakes

State/Province

Florida

ZIP/Postal Code

33313

Country

United States

Facility Name

Research Site

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33140

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Facility Name

AMPM Research Clinic

City

Miami

State/Province

Florida

ZIP/Postal Code

33145

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33150

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

Research Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Research Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33026

Country

United States

Facility Name

Research Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Research Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Research Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30904

Country

United States

Facility Name

Research Site #1

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Research Site #2

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Research Site #1

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

Research Site #2

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

Research Site

City

Roswell

State/Province

Georgia

ZIP/Postal Code

30076

Country

United States

Facility Name

Research Site

City

Statesboro

State/Province

Georgia

ZIP/Postal Code

30458

Country

United States

Facility Name

Research Site

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Research Site

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46804

Country

United States

Facility Name

Research Site

City

Merrillville

State/Province

Indiana

ZIP/Postal Code

46410

Country

United States

Facility Name

Research Site

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71201

Country

United States

Facility Name

Research Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71101

Country

United States

Facility Name

Research Site

City

Takoma Park

State/Province

Maryland

ZIP/Postal Code

20912

Country

United States

Facility Name

Research Site

City

Springfield

State/Province

Massachusetts

ZIP/Postal Code

01107

Country

United States

Facility Name

Research Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Research Site

City

Pontiac

State/Province

Michigan

ZIP/Postal Code

48341

Country

United States

Facility Name

Research Site

City

Port Huron

State/Province

Michigan

ZIP/Postal Code

91344

Country

United States

Facility Name

Research Site

City

Roseville

State/Province

Michigan

ZIP/Postal Code

48066

Country

United States

Facility Name

Research Site

City

Columbus

State/Province

Mississippi

ZIP/Postal Code

39705

Country

United States

Facility Name

Research Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63136

Country

United States

Facility Name

Research Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

Research Site

City

Gallup

State/Province

New Mexico

ZIP/Postal Code

87301

Country

United States

Facility Name

Research Site

City

Santa Fe

State/Province

New Mexico

ZIP/Postal Code

87505

Country

United States

Facility Name

Research Site

City

Astoria

State/Province

New York

ZIP/Postal Code

11102

Country

United States

Facility Name

Research Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Research Site

City

Flushing

State/Province

New York

ZIP/Postal Code

11355

Country

United States

Facility Name

Research Site

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10010

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Research Site

City

Yonkers

State/Province

New York

ZIP/Postal Code

10710

Country

United States

Facility Name

Research Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

Research Site #1

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Research Site #2

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Research Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27704

Country

United States

Facility Name

Research Site

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Research Site #1

City

New Bern

State/Province

North Carolina

ZIP/Postal Code

28562

Country

United States

Facility Name

Research Site #2

City

New Bern

State/Province

North Carolina

ZIP/Postal Code

28562

Country

United States

Facility Name

Research Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19106

Country

United States

Facility Name

Research Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

Research Site #1

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37408

Country

United States

Facility Name

Research Site #2

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37408

Country

United States

Facility Name

Research Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37923

Country

United States

Facility Name

Research Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37205

Country

United States

Facility Name

Research Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76015

Country

United States

Facility Name

Research Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Research Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78751

Country

United States

Facility Name

Research Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78758

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

Research Site

City

Duncanville

State/Province

Texas

ZIP/Postal Code

75137

Country

United States

Facility Name

Research Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

77429

Country

United States

Facility Name

Research Site

City

Greenville

State/Province

Texas

ZIP/Postal Code

75402

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77054

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77099

Country

United States

Facility Name

Research Site

City

McAllen

State/Province

Texas

ZIP/Postal Code

78503

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78202

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78207

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78212-4740

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78221

Country

United States

Facility Name

Research Site #2

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78251

Country

United States

Facility Name

Research Site

City

Saint George

State/Province

Utah

ZIP/Postal Code

84790

Country

United States

Facility Name

Research Site

City

South Burlington

State/Province

Vermont

ZIP/Postal Code

05403

Country

United States

Facility Name

Research Site

City

Hampton

State/Province

Virginia

ZIP/Postal Code

23666

Country

United States

Facility Name

Research Site

City

Manassas

State/Province

Virginia

ZIP/Postal Code

20110

Country

United States

Facility Name

Research Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Research Site

City

Ciudad Autonoma Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

Research Site

City

Junin

State/Province

Buenos Aires

ZIP/Postal Code

6000

Country

Argentina

Facility Name

Research Site

City

Pergamino

State/Province

Buenos Aires

ZIP/Postal Code

B2700CPM

Country

Argentina

Facility Name

Research Site

City

Sarandi

State/Province

Buenos Aires

ZIP/Postal Code

B1872EEA

Country

Argentina

Facility Name

Research Site

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Research Site

City

Cordoba

ZIP/Postal Code

X5000EVQ

Country

Argentina

Facility Name

Research Site

City

Corrientes

ZIP/Postal Code

3400

Country

Argentina

Facility Name

Research Site

City

Salta

ZIP/Postal Code

A4400AXO

Country

Argentina

Facility Name

Research Site

City

San Luis

ZIP/Postal Code

5700

Country

Argentina

Facility Name

Research Site

City

Liverpool

State/Province

New South Wales

ZIP/Postal Code

2170

Country

Australia

Facility Name

Research Site

City

New Lambton Heights

State/Province

New South Wales

ZIP/Postal Code

2305

Country

Australia

Facility Name

Research Site

City

Wahroonga

State/Province

New South Wales

ZIP/Postal Code

2076

Country

Australia

Facility Name

Research Site

City

Cairns

State/Province

Queensland

ZIP/Postal Code

4870

Country

Australia

Facility Name

Research Site

City

Launceston

State/Province

Tasmania

ZIP/Postal Code

7250

Country

Australia

Facility Name

Research Site

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

Research Site

City

Fitzroy

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

Research Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Research Site

City

Feira de Santana

State/Province

Bahia

ZIP/Postal Code

44001-584

Country

Brazil

Facility Name

Research Site

City

Itabuna

State/Province

Bahia

ZIP/Postal Code

45600-625

Country

Brazil

Facility Name

Research Site

City

Fortaleza

State/Province

Ceará

ZIP/Postal Code

60430-370

Country

Brazil

Facility Name

Research Site

City

Vitória

State/Province

Espírito Santo

ZIP/Postal Code

29055-450

Country

Brazil

Facility Name

Research Site

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30130-100

Country

Brazil

Facility Name

Research Site

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30150-221

Country

Brazil

Facility Name

Research Site

City

Juiz de Fora

State/Province

Minas Gerais

ZIP/Postal Code

36025-330

Country

Brazil

Facility Name

Research Site

City

Juiz de Fora

State/Province

Minas Gerais

ZIP/Postal Code

36036-330

Country

Brazil

Facility Name

Research Site

City

Curitiba

State/Province

Paraná

ZIP/Postal Code

80010-030

Country

Brazil

Facility Name

Research Site

City

Maringá

State/Province

Paraná

ZIP/Postal Code

87060-040

Country

Brazil

Facility Name

Research Site

City

Canoas

State/Province

Rio Grande Do Sul

ZIP/Postal Code

92425-900

Country

Brazil

Facility Name

Research Site

City

Passo Fundo

State/Province

Rio Grande Do Sul

ZIP/Postal Code

99010-080

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-074

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90160-093

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Research Site

City

Criciúma

State/Province

Santa Catarina

ZIP/Postal Code

88801-250

Country

Brazil

Facility Name

Research Site

City

Joinville

State/Province

Santa Catarina

ZIP/Postal Code

89202-050

Country

Brazil

Facility Name

Research Site

City

Santo André

State/Province

Sao Paulo

ZIP/Postal Code

09080-110

Country

Brazil

Facility Name

Research Site

City

Santo André

State/Province

Sao Paulo

ZIP/Postal Code

09090-790

Country

Brazil

Facility Name

Research Site

City

São Bernardo do Campo

State/Province

Sao Paulo

ZIP/Postal Code

09715-090

Country

Brazil

Facility Name

Research Site

City

São José do Rio Preto

State/Province

Sao Paulo

ZIP/Postal Code

15015-200

Country

Brazil

Facility Name

Research Site

City

São Paulo

State/Province

Sao Paulo

ZIP/Postal Code

01232-010

Country

Brazil

Facility Name

Research Site

City

São Paulo

State/Province

Sao Paulo

ZIP/Postal Code

04039-000

Country

Brazil

Facility Name

Research Site

City

São Paulo

State/Province

Sao Paulo

ZIP/Postal Code

05403-000

Country

Brazil

Facility Name

Research Site

City

Byala

ZIP/Postal Code

7100

Country

Bulgaria

Facility Name

Research Site

City

Cherven bryag

ZIP/Postal Code

5980

Country

Bulgaria

Facility Name

Research Site

City

Dobrich

ZIP/Postal Code

9300

Country

Bulgaria

Facility Name

Research Site

City

Dupnitsa

ZIP/Postal Code

2600

Country

Bulgaria

Facility Name

Research Site

City

Haskovo

ZIP/Postal Code

6300

Country

Bulgaria

Facility Name

Research Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Research Site

City

Ruse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

Research Site

City

Shumen

ZIP/Postal Code

9700

Country

Bulgaria

Facility Name

Research Site

City

Silistra

ZIP/Postal Code

7500

Country

Bulgaria

Facility Name

Research Site

City

Sliven

ZIP/Postal Code

8800

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1750

Country

Bulgaria

Facility Name

Research Site

City

Varna

ZIP/Postal Code

9002

Country

Bulgaria

Facility Name

Research Site

City

Veliko Tarnovo

ZIP/Postal Code

5000

Country

Bulgaria

Facility Name

Research Site

City

Vidin

ZIP/Postal Code

3700

Country

Bulgaria

Facility Name

Research Site

City

Vratsa

ZIP/Postal Code

3000

Country

Bulgaria

Facility Name

Research Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y0

Country

Canada

Facility Name

Research Site

City

Sydney

State/Province

Nova Scotia

ZIP/Postal Code

B1P 1P3

Country

Canada

Facility Name

Research Site

City

Oshawa

State/Province

Ontario

ZIP/Postal Code

L1H 1B9

Country

Canada

Facility Name

Research Site

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E 5J1

Country

Canada

Facility Name

Research Site

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2H1

Country

Canada

Facility Name

Research Site

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H2X 3J4

Country

Canada

Facility Name

Research Site

City

Marseille

State/Province

Bouches-du-Rhône

ZIP/Postal Code

13005

Country

France

Facility Name

Research Site

City

Bordeaux

State/Province

Gironde

ZIP/Postal Code

33300

Country

France

Facility Name

Research Site

City

Saint-Priest-En-Jarez

State/Province

Loire

ZIP/Postal Code

42055

Country

France

Facility Name

Research Site

City

Reims

State/Province

Marne

ZIP/Postal Code

51092

Country

France

Facility Name

Research Site

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Research Site

City

Paris

ZIP/Postal Code

75020

Country

France

Facility Name

Research Site

City

Villingen-Schwenningen

State/Province

Baden Wuerttemberg

ZIP/Postal Code

78054

Country

Germany

Facility Name

Research Site

City

Rostock

State/Province

Mecklenburg Vorpommern

ZIP/Postal Code

18057

Country

Germany

Facility Name

Research Site

City

Duesseldorf

State/Province

Nordrhein Westfalen

ZIP/Postal Code

40210

Country

Germany

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Research Site

City

Ashkelon

ZIP/Postal Code

78278

Country

Israel

Facility Name

Research Site

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Research Site

City

Haifa

ZIP/Postal Code

34362

Country

Israel

Facility Name

Research Site

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Research Site

City

Kfar- Saba

ZIP/Postal Code

4428164

Country

Israel

Facility Name

Research Site

City

Rishon Lezion

ZIP/Postal Code

75141

Country

Israel

Facility Name

Research Site

City

Bari

ZIP/Postal Code

70124

Country

Italy

Facility Name

Research Site

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Research Site

City

Lecco

ZIP/Postal Code

23900

Country

Italy

Facility Name

Research Site

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Research Site

City

Roma

ZIP/Postal Code

168

Country

Italy

Facility Name

Research Site

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Research Site

City

Chuncheon

State/Province

Gangwon-do

ZIP/Postal Code

200-702

Country

Korea, Republic of

Facility Name

Research Site

City

Bucheon-si

State/Province

Gyeonggi-do

ZIP/Postal Code

14647

Country

Korea, Republic of

Facility Name

Research Site

City

Goyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

10380

Country

Korea, Republic of

Facility Name

Research Site

City

Goyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

10444

Country

Korea, Republic of

Facility Name

Research Site

City

Guri

State/Province

Gyeonggi-do

ZIP/Postal Code

11923

Country

Korea, Republic of

Facility Name

Research Site

City

Seongnam-si,

State/Province

Gyeonggi-do

ZIP/Postal Code

13496

Country

Korea, Republic of

Facility Name

Research Site

City

Suwon-si

State/Province

Gyeonggi-do

ZIP/Postal Code

16247

Country

Korea, Republic of

Facility Name

Research Site

City

Busan

ZIP/Postal Code

47392

Country

Korea, Republic of

Facility Name

Research Site

City

Busan

ZIP/Postal Code

49201

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

2841

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

3080

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

6351

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

6591

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

7345

Country

Korea, Republic of

Facility Name

Research Site

City

Pachuca

State/Province

Hidalgo

ZIP/Postal Code

42070

Country

Mexico

Facility Name

Research Site

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45030

Country

Mexico

Facility Name

Research Site

City

Morelia

State/Province

Michoacán

ZIP/Postal Code

58260

Country

Mexico

Facility Name

Research Site

City

Culiacan

State/Province

Sinaloa

ZIP/Postal Code

80230

Country

Mexico

Facility Name

Research Site

City

Biala Podlaska

ZIP/Postal Code

21-500

Country

Poland

Facility Name

Research Site

City

Golub Dobrzyn

ZIP/Postal Code

87-400

Country

Poland

Facility Name

Research Site

City

Kolobrzeg

ZIP/Postal Code

78-100

Country

Poland

Facility Name

Research Site

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Research Site

City

Lodz

ZIP/Postal Code

92-213

Country

Poland

Facility Name

Research Site

City

Lodz

ZIP/Postal Code

93-338

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

04-749

Country

Poland

Facility Name

Research Site

City

Beja

ZIP/Postal Code

7800-309

Country

Portugal

Facility Name

Research Site

City

Leiria

ZIP/Postal Code

2400-441

Country

Portugal

Facility Name

Research Site

City

Loures

ZIP/Postal Code

2674-514

Country

Portugal

Facility Name

Research Site

City

Ekaterinburg

ZIP/Postal Code

620102

Country

Russian Federation

Facility Name

Research Site #2

City

Kemerovo

ZIP/Postal Code

650066

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

123182

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

125466

Country

Russian Federation

Facility Name

Research Site

City

Nizhniy Novgorod

ZIP/Postal Code

603001

Country

Russian Federation

Facility Name

Research Site

City

Nizhniy Novgorod

ZIP/Postal Code

603076

Country

Russian Federation

Facility Name

Research Site

City

Novorossiysk

ZIP/Postal Code

353915

Country

Russian Federation

Facility Name

Research Site

City

Saint-Petersburg

ZIP/Postal Code

195067

Country

Russian Federation

Facility Name

Research Site

City

Saint-Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Research Site

City

Saint-Petersburg

ZIP/Postal Code

197110

Country

Russian Federation

Facility Name

Research Site

City

St. Petersburg

ZIP/Postal Code

198205

Country

Russian Federation

Facility Name

Research Site

City

St. Petersburg

ZIP/Postal Code

199004

Country

Russian Federation

Facility Name

Research Site #1

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Research Site #2

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Research Site #3

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Research Site #4

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Research Site

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Research Site

City

Nis

ZIP/Postal Code

18000

Country

Serbia

Facility Name

Research Site

City

Zajecar

ZIP/Postal Code

19000

Country

Serbia

Facility Name

Research Site

City

Brovary

ZIP/Postal Code

7400

Country

Ukraine

Facility Name

Research Site #1

City

Cherkassy

ZIP/Postal Code

18009

Country

Ukraine

Facility Name

Research Site

City

Dnipro

ZIP/Postal Code

49005

Country

Ukraine

Facility Name

Research Site

City

Ivano-Frankivsk

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

ZIP/Postal Code

61037

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

2125

Country

Ukraine

Facility Name

Research Site

City

Mykolaiv

ZIP/Postal Code

54058

Country

Ukraine

Facility Name

Research Site

City

Ternopil

ZIP/Postal Code

46002

Country

Ukraine

Facility Name

Research Site

City

Uzhgorod

ZIP/Postal Code

88018

Country

Ukraine

Facility Name

Research Site

City

Vinnytsia

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

Research Site

City

Zaporizhzhia

ZIP/Postal Code

69600

Country

Ukraine

Facility Name

Research Site

City

Zhytomyr

ZIP/Postal Code

10002

Country

Ukraine

Facility Name

Research Site

City

Cambridge

State/Province

Cambridgeshire

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Research Site

City

London

State/Province

Greater London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Research Site

City

Stevenage

State/Province

Hertfordshire

ZIP/Postal Code

SG1 4AB

Country

United Kingdom

Facility Name

Research Site

City

Kettering

State/Province

Leicestershire

ZIP/Postal Code

NN16 8DB

Country

United Kingdom

Facility Name

Research Site

City

Doncaster

State/Province

South Yorkshire

ZIP/Postal Code

DN2 5LT

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36005278

Citation

Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

Results Reference

derived

PubMed Identifier

33913638

Citation

Eckardt KU, Agarwal R, Aswad A, Awad A, Block GA, Bacci MR, Farag YMK, Fishbane S, Hubert H, Jardine A, Khawaja Z, Koury MJ, Maroni BJ, Matsushita K, McCullough PA, Lewis EF, Luo W, Parfrey PS, Pergola P, Sarnak MJ, Spinowitz B, Tumlin J, Vargo DL, Walters KA, Winkelmayer WC, Wittes J, Zwiech R, Chertow GM. Safety and Efficacy of Vadadustat for Anemia in Patients Undergoing Dialysis. N Engl J Med. 2021 Apr 29;384(17):1601-1612. doi: 10.1056/NEJMoa2025956.

Results Reference

derived

Learn more about this trial

Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)

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Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)

Anemia, Dialysis-Dependent Chronic Kidney Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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