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)
CompletedPhase 3Results postedLast updated 22 May 2025
What this trial tests
Phase 3 trial testing Vadadustat in Anemia in 319 participants. Completed in 22 June 2022.
18 and older, any sex, with Anemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Hb to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26)Primary· Baseline; Weeks 20 to 26
The Baseline Hb was defined as the average of the last 2 central laboratory Hb values taken on or prior to the first dose date. The average for the PEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 20 through 26, regardless of intercurrent events. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as PEP value minus the Baseline value.
Group
Value
95% CI
Vadadustat QD
0.07
± 0.12
Vadadustat TIW
-0.19
± 0.12
Darbepoetin Alfa
0.34
± 0.12
Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52)Secondary· Baseline; Weeks 46 to 52
The Baseline Hb was defined as the average of the last 2 central laboratory Hb values taken on or prior to the first dose date. The average for the SEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 46 through 52, regardless of intercurrent events. Analysis was conducted using an ANCOVA model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as SEP value minus the Baseline value.
Group
Value
95% CI
Vadadustat QD
0.04
± 0.15
Vadadustat TIW
0.03
± 0.15
Darbepoetin Alfa
0.44
± 0.15
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug (Day 1) up to Week 56 (from first dose of study drug to last dose + 4 weeks of follow-up).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This trial will be conducted to demonstrate the efficacy and safety of vadadustat compared to darbepoetin alfa for the maintenance treatment of anemia in hemodialysis participants after conversion from current erythropoiesis-stimulating agent (ESA) therapy.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07537816 — Effects of Vadadustat on Anemia, Quality of Life, and Inflammation in Dialysis Patients
· Phase 4
· not yet recruiting
NCT06520826 — Vafseo Outcomes In-Center Experience
· Phase 3
· active not recruiting
NCT04707768 — Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera
· Phase 3
· completed
NCT04299633 — Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Va
· Phase 1
· completed
NCT03992066 — Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia
· Phase 1
· completed
Other recruiting trials for Anemia
Currently open trials in the same condition.
NCT07422480 — A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myel
· Phase 3
· recruiting
NCT06968936 — Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy
· NA
· recruiting
NCT07328191 — Quality of Life-Guided Transfusion in Refractory MDS or AML
· NA
· recruiting
NCT07315295 — Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya
· NA
· recruiting
NCT07400796 — Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia
· recruiting
Other Akebia Therapeutics trials
Trials by the same sponsor.
NCT04707768 — Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera
· Phase 3
· completed
NCT04299633 — Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Va
· Phase 1
· completed
NCT03992066 — Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia
· Phase 1
· completed
NCT03799627 — Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa
· Phase 2
· completed
NCT03789032 — Study to Evaluate the Effect of Rabeprazole on the Pharmacokinetics of Vadadustat
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Akebia Therapeutics
Last refreshed: 22 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04313153.