Back to resultsEfficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident 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
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring Vadadustat, AKB-6548, anemia, chronic kidney disease, CKD, chronic renal insufficiency, renal impairment, erythropoietin, kidney, renal, oral anemia treatment, hemoglobin, hypoxia-inducible factor, HIF, efficacy, safety, phase 3, cardiovascular
Eligibility Criteria
Inclusion Criteria:
- ≥18 years of age
- Initiated chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease within 16 weeks prior to Screening
- Mean Screening hemoglobin between 8.0 and <11.0 grams per deciliter (g/dL) (inclusive)
- Serum ferritin ≥100 nanograms per deciliter (ng/mL) and 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
- Red blood cells transfusion within 8 weeks prior to randomization
- Anticipated to recover adequate kidney function to no longer require dialysis
- Uncontrolled hypertension
- Severe heart failure at Screening (New York Heart Association Class IV)
- Acute coronary syndrome (hospitalization for unstable angina, 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 congestive heart failure; or stroke within 12 weeks prior to or during Screening.
Participants meeting the criteria of erythropoiesis-stimulating agent resistance within 8 weeks prior to or during Screening defined as follows
- epoetin: > 7700 units/dose three times per week or >23,000 units per week
- Darbepoetin alfa: >100 micrograms per week (mcg/week)
- methoxy polyethylene glycol-epoetin beta: >100 micrograms (mcg) every other week or >200 mcg/month
- Hypersensitivity to Vadadustat, Darbepoetin alfa or any of their excipients
Sites / Locations
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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 (<9.5 versus ≥9.5 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-0016 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 (<9.5 versus ≥9.5 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-0016 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-0016 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-0016 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-0016 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
1. Study Identification
Unique Protocol Identification Number
NCT02865850
Brief Title
Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident 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 Correction or Maintenance Treatment of Anemia in Subjects With Incident Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE - CORRECTION/CONVERSION)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
January 31, 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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction or maintenance treatment of anemia in participants with incident 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 correction or maintenance treatment in participants with anemia secondary to chronic kidney disease who have recently initiated dialysis treatment for end-stage renal disease.
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
Vadadustat, AKB-6548, anemia, chronic kidney disease, CKD, chronic renal insufficiency, renal impairment, erythropoietin, kidney, renal, oral anemia treatment, hemoglobin, hypoxia-inducible factor, HIF, efficacy, safety, phase 3, cardiovascular
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
369 (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
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 (<9.5 versus ≥9.5 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.
Time Frame
Baseline; Weeks 24 to 36
Title
Median Time to First Major Adverse Cardiovascular Event (MACE)
Description
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-0016 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.
Time Frame
Up to 176 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 (<9.5 versus ≥9.5 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
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-0016 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.
Time Frame
Up to 176 weeks
Title
Median Time to First Cardiovascular MACE
Description
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-0016 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.
Time Frame
Up to 176 weeks
Title
Median Time to First Cardiovascular Death
Description
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-0016 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.
Time Frame
Up to 176 weeks
Title
Median Time to First All-cause Mortality
Description
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-0016 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.
Time Frame
Up to 176 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
No
Eligibility Criteria
Inclusion Criteria:
≥18 years of age
Initiated chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease within 16 weeks prior to Screening
Mean Screening hemoglobin between 8.0 and <11.0 grams per deciliter (g/dL) (inclusive)
Serum ferritin ≥100 nanograms per deciliter (ng/mL) and 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
Red blood cells transfusion within 8 weeks prior to randomization
Anticipated to recover adequate kidney function to no longer require dialysis
Uncontrolled hypertension
Severe heart failure at Screening (New York Heart Association Class IV)
Acute coronary syndrome (hospitalization for unstable angina, 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 congestive heart failure; or stroke within 12 weeks prior to or during Screening.
Participants meeting the criteria of erythropoiesis-stimulating agent resistance within 8 weeks prior to or during Screening defined as follows
epoetin: > 7700 units/dose three times per week or >23,000 units per week
Darbepoetin alfa: >100 micrograms per week (mcg/week)
methoxy polyethylene glycol-epoetin beta: >100 micrograms (mcg) every other week or >200 mcg/month
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
Anaheim
State/Province
California
ZIP/Postal Code
92801
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
Downey
State/Province
California
ZIP/Postal Code
90240
Country
United States
Facility Name
Research Site
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Research Site
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
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
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
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
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92115
Country
United States
Facility Name
Research Site
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
Research Site
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Research Site
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80002
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
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
33071
Country
United States
Facility Name
Research Site
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
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33150
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
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
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
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
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20912
Country
United States
Facility Name
Research Site
City
Roseville
State/Province
Michigan
ZIP/Postal Code
48066
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
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
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
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 #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
El Paso
State/Province
Texas
ZIP/Postal Code
79935
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
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
78229
Country
United States
Facility Name
Research Site
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Research Site
City
Bahia Blanca
State/Province
Buenos Aires
ZIP/Postal Code
B8001HXM
Country
Argentina
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
Temperley
State/Province
Buenos Aires
ZIP/Postal Code
1834
Country
Argentina
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
5000
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
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60430-370
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
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
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
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 Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04039-000
Country
Brazil
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
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
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
Napoli
ZIP/Postal Code
80138
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
Seongnam-si,
State/Province
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Research Site
City
Busan
ZIP/Postal Code
47392
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
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
Golub Dobrzyn
ZIP/Postal Code
87-400
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
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 #2
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Research Site
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
125466
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
City
Brovary
ZIP/Postal Code
7400
Country
Ukraine
Facility Name
Research Site
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
12. IPD Sharing Statement
Plan to Share IPD
No
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 Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)
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