NCT03263091Phase 3Terminated

Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden

Study sponsor: Kyntra Bio

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 completion2023-03-09Actual

Enrollment · participants184Actual

Source updated2024-08-01Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts); Anemia

Treatments or interventions studied

RoxadustatDrugAlso known as FG-4592, ASP1517, AZD9941
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: OL and OL High-EPO Components: Number of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) ≥8 Weeks (≥56 Consecutive Days) Since First Dose in the First 28 Weeks of Treatment; description: The RBC TI was defined as the absence of any intravenous (IV) RBC transfusion (packed cell or whole blood) during any consecutive 56 days during the treatment period. Data presented is for number of participants with RBC TI ≥8 weeks (≥56 consecutive days) since first dose in the first 28 weeks of treatment.; timeFrame: 28 weeks; measure: DB Component: Number of Participants Who Achieved RBC TI ≥56 Consecutive Days Since First Dose in the First 28 Weeks of Treatment; description: RBC TI was defined as the absence of any IV RBC transfusion (packed cell or whole blood) during any consecutive 56 days during the treatment period. Data presented is for number of participants with RBC TI ≥56 consecutive days since first dose in the first 28 weeks of treatment.; timeFrame: 28 weeks

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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