NCT04313153Phase 3Completed

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)

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2021-11-26Actual

Enrollment · participants319Actual

Source updated2025-05-22Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Anemia

Treatments or interventions studied

VadadustatDrug
Darbepoetin alfaDrug

Primary outcomes · main study measures

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measure: Change From Baseline in Hb to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26); description: 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.; timeFrame: Baseline; Weeks 20 to 26

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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