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Showing 1–24 of 27 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: AKB-6548 Clear all
Withdrawn Phase 3 Interventional

Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease

NCT05082571
View directory record Official record
Conditions
Anemia of Chronic Kidney Disease
Interventions
vadadustat
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
4 Months to 16 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
1
States / cities
Hackensack, New Jersey
Source: ClinicalTrials.gov public record
Updated Sep 30, 2025 · Synced Sep 3, 2026, 4:19 PM EDT
Completed Phase 3 Interventional Results available

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

NCT02680574
View directory record Official record
Conditions
Anemia, Non-Dialysis-Dependent Chronic Kidney Disease
Interventions
Vadadustat, Darbepoetin alfa
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
1,725 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
219
States / cities
Birmingham, Alabama • Huntsville, Alabama • Tuscumbia, Alabama + 158 more
Source: ClinicalTrials.gov public record
Updated Jun 26, 2022 · Synced Sep 3, 2026, 4:19 PM EDT
Completed Phase 3 Interventional Results available

Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)

NCT04313153
View directory record Official record
Conditions
Anemia
Interventions
Vadadustat, Darbepoetin alfa
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
319 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
39
States / cities
Chula Vista, California • Granada Hills, California • Los Angeles, California + 31 more
Source: ClinicalTrials.gov public record
Updated May 21, 2025 · Synced Sep 3, 2026, 4:19 PM EDT
Recruiting Phase 2Phase 3 Interventional

Vadadustat for the Treatment of Nonintubated Acute Respiratory Distress Syndrome Due to Pathogen-Associated Lung Injury

NCT07086755
View directory record Official record
Conditions
Nonintubated Acute Respiratory Distress Syndrome (ARDS), Pathogen-associated Lung Injury
Interventions
Vadadustat 900mg, Vadadustat 1200mg, Placebo
Drug
Lead sponsor
Paul Potnuru
Other
Eligibility
18 Years and older
Enrollment
1,100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2031
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Aug 9, 2026 · Synced Sep 3, 2026, 4:19 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult Subjects

NCT02412449
View directory record Official record
Conditions
Healthy
Interventions
AKB-6548 tablet, reference formulation given in the fasted state, AKB-6548 tablet, test formulation given in the fasted state., AKB-6548 tablet, test formulation given in the fed state
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
18 Years to 55 Years
Enrollment
18 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
Kalamazoo, Michigan
Source: ClinicalTrials.gov public record
Updated Nov 13, 2018 · Synced Sep 3, 2026, 4:19 PM EDT
Completed Phase 2 Interventional Results available

Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Participants With Chronic Kidney Disease (CKD), Stages 3 and 4

NCT04707573
View directory record Official record
Conditions
Chronic Kidney Disease
Interventions
Vadadustat
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
18 Years to 79 Years
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010
U.S. locations
2
States / cities
Saint Paul, Minnesota • Knoxville, Tennessee
Source: ClinicalTrials.gov public record
Updated Jun 27, 2022 · Synced Sep 3, 2026, 4:19 PM EDT
Completed Phase 2 Interventional Results available

Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa

NCT03799627
View directory record Official record
Conditions
Anemia, Dialysis-dependent Chronic Kidney Disease
Interventions
Vadadustat, Epoetin Alfa, Vadadustat TIW
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
18 Years to 99 Years
Enrollment
175 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
41
States / cities
Fresno, California • Granada Hills, California • Los Angeles, California + 32 more
Source: ClinicalTrials.gov public record
Updated Sep 28, 2022 · Synced Sep 3, 2026, 4:19 PM EDT
Completed Phase 1 Interventional

Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease

NCT03992066
View directory record Official record
Conditions
Anemia Associated With Chronic Kidney Disease
Interventions
Vadadustat, Darbepoetin alfa, Epoetin alfa
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
46 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
10
States / cities
Escondido, California • Denver, Colorado • Fort Lauderdale, Florida + 7 more
Source: ClinicalTrials.gov public record
Updated Sep 15, 2020 · Synced Sep 3, 2026, 4:19 PM EDT
Completed Phase 2 Interventional Results available

42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia

NCT01381094
View directory record Official record
Conditions
Anemia, Kidney Disease
Interventions
AKB-6548, Placebo
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
18 Years to 79 Years
Enrollment
93 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2012
U.S. locations
28
States / cities
Pine Bluff, Arkansas • Covina, California • Los Angeles, California + 25 more
Source: ClinicalTrials.gov public record
Updated Jun 30, 2022 · Synced Sep 3, 2026, 4:19 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study in Evaluating Bioequivalence of Test and Reference Vadadustat 450 MG and 150 MG Tablets and to Determine Food Effect on the 450 MG Tablet

NCT03657290
View directory record Official record
Conditions
Healthy
Interventions
vadadustat
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
18 Years to 55 Years
Enrollment
54 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Mar 21, 2019 · Synced Sep 3, 2026, 4:19 PM EDT
Active, not recruiting Phase 3 Interventional

Vafseo Outcomes In-Center Experience

NCT06520826
View directory record Official record
Conditions
Anemia of Chronic Kidney Disease
Interventions
Vadadustat, Erythropoiesis Stimulating Agent
Drug
Lead sponsor
USRC Kidney Research
Network
Eligibility
18 Years and older
Enrollment
2,200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
5
States / cities
Lone Tree, Colorado • Dalton, Georgia • Gallup, New Mexico + 2 more
Source: ClinicalTrials.gov public record
Updated Mar 9, 2026 · Synced Sep 3, 2026, 4:19 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers

NCT02062203
View directory record Official record
Conditions
Healthy Volunteers
Interventions
AKB-6548 (therapeutic dose), AKB-6548 (supratherapeutic dose), Placebo, Moxifloxacin
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
18 Years to 55 Years
Enrollment
50 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Evansville, Indiana
Source: ClinicalTrials.gov public record
Updated Nov 13, 2018 · Synced Sep 3, 2026, 4:19 PM EDT
Active, not recruiting Phase 3 Interventional

To Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis

NCT06901505
View directory record Official record
Conditions
Anemia of Chronic Kidney Disease
Interventions
Erythropoiesis-Stimulating Agent (ESA), Vadadustat
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
353 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
18
States / cities
Montgomery, Alabama • Hartford, Connecticut • Middlebury, Connecticut + 9 more
Source: ClinicalTrials.gov public record
Updated Feb 22, 2026 · Synced Sep 3, 2026, 4:19 PM EDT
Completed Phase 3 Interventional Results available

Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects

NCT04707768
View directory record Official record
Conditions
Anemia Associated With Chronic Kidney Disease (CKD)
Interventions
Vadadustat, Mircera®
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
456 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
58
States / cities
Huntsville, Alabama • Phoenix, Arizona • Pine Bluff, Arkansas + 51 more
Source: ClinicalTrials.gov public record
Updated Jan 14, 2025 · Synced Sep 3, 2026, 4:19 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study in Evaluating Bioequivalence Between Test and Reference Formulations of Vadadustat Tablets in Healthy Adults

NCT03639155
View directory record Official record
Conditions
Healthy
Interventions
vadadustat reference tablets, vadadustat test tablets
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
18 Years to 55 Years
Enrollment
50 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Mar 21, 2019 · Synced Sep 3, 2026, 4:19 PM EDT
Withdrawn Phase 3 Interventional

Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents

NCT05082584
View directory record Official record
Conditions
Anemia of Chronic Kidney Disease
Interventions
Vadadustat
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
4 Months to 16 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
1
States / cities
Hackensack, New Jersey
Source: ClinicalTrials.gov public record
Updated Sep 30, 2025 · Synced Sep 3, 2026, 4:19 PM EDT
Completed Phase 3 Interventional Results available

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

NCT02892149
View directory record Official record
Conditions
Anemia, Dialysis-Dependent Chronic Kidney Disease
Interventions
Vadadustat, Darbepoetin alfa
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
3,554 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
127
States / cities
Huntsville, Alabama • Mesa, Arizona • Pine Bluff, Arkansas + 95 more
Source: ClinicalTrials.gov public record
Updated Jun 27, 2022 · Synced Sep 3, 2026, 4:19 PM EDT
Terminated Phase 2 Interventional Results available

Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents

NCT03140722
View directory record Official record
Conditions
Anemia, Dialysis-Dependent Chronic Kidney Disease
Interventions
vadadustat, epoetin alfa
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
18
States / cities
Bakersfield, California • Elk Grove, California • Encino, California + 15 more
Source: ClinicalTrials.gov public record
Updated Feb 20, 2021 · Synced Sep 3, 2026, 4:19 PM EDT
Completed Phase 2 Interventional Results available

Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)

NCT04478071
View directory record Official record
Conditions
Acute Respiratory Distress Syndrome, Coronavirus Infection
Interventions
vadadustat, placebo
Drug
Lead sponsor
The University of Texas Health Science Center, Houston
Other
Eligibility
18 Years and older
Enrollment
448 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Mar 25, 2025 · Synced Sep 3, 2026, 4:19 PM EDT
Completed Phase 3 Interventional Results available

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)

NCT02865850
View directory record Official record
Conditions
Anemia, Dialysis-Dependent Chronic Kidney Disease
Interventions
Vadadustat, Darbepoetin alfa
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
369 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
54
States / cities
Huntsville, Alabama • Mesa, Arizona • Anaheim, California + 45 more
Source: ClinicalTrials.gov public record
Updated Jul 17, 2022 · Synced Sep 3, 2026, 4:19 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Effects of Ferrous Sulfate on the Pharmacokinetics of AKB-6548

NCT02327546
View directory record Official record
Conditions
Healthy Volunteers
Interventions
AKB-6548, Ferrous Sulfate
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
18 Years to 55 Years · Male only
Enrollment
10 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014 – 2015
U.S. locations
1
States / cities
Kalamazoo, Michigan
Source: ClinicalTrials.gov public record
Updated Nov 13, 2018 · Synced Sep 3, 2026, 4:19 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function

NCT03799848
View directory record Official record
Conditions
Hepatic Impairment
Interventions
Vadadustat
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
18 Years to 70 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018
U.S. locations
2
States / cities
Saint Paul, Minnesota • San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Mar 21, 2019 · Synced Sep 3, 2026, 4:19 PM EDT
Completed Phase 3 Interventional Results available

Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease

NCT02648347
View directory record Official record
Conditions
Anemia, Non-Dialysis-Dependent Chronic Kidney Disease
Interventions
Vadadustat, Darbepoetin alfa
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
1,751 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
208
States / cities
Huntsville, Alabama • Tuscumbia, Alabama • Glendale, Arizona + 148 more
Source: ClinicalTrials.gov public record
Updated Jun 26, 2022 · Synced Sep 3, 2026, 4:19 PM EDT
Completed Phase 2 Interventional Results available

20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia

NCT01906489
View directory record Official record
Conditions
Anemia, Chronic Kidney Disease
Interventions
AKB-6548, Placebo
Drug
Lead sponsor
Akebia Therapeutics
Industry
Eligibility
18 Years to 82 Years
Enrollment
210 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
47
States / cities
Glendale, Arizona • Tucson, Arizona • Azusa, California + 44 more
Source: ClinicalTrials.gov public record
Updated Jul 20, 2022 · Synced Sep 3, 2026, 4:19 PM EDT