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Trial · NCT03263091

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
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
OL Component (Cohort 1): Roxadustat 1.5 mg/kg3Participants
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
OL Component (Cohort 2): Roxadustat 2.0 mg/kg1Participants
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
OL Component (Cohort 3): Roxadustat 2.5 mg/kg5Participants
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
OL High-EPO Component: Roxadustat 2.5 mg/kg3Participants
DB Component: Number of Participants Who Achieved RBC TI ≥56 Consecutive Days Since First Dose in the First 28 Weeks of TreatmentDB Component: Roxadustat38Participants
DB Component: Number of Participants Who Achieved RBC TI ≥56 Consecutive Days Since First Dose in the First 28 Weeks of TreatmentDB Component: Placebo19Participants
OL and OL High-EPO Components: Number of Participants Who Achieved TI ≥50% Reduction From Baseline in Number of Packs of Red Blood Cells (pRBC) Transfusions Over 8 WeeksOL Component (Cohort 1): Roxadustat 1.5 mg/kg5Participants
OL and OL High-EPO Components: Number of Participants Who Achieved TI ≥50% Reduction From Baseline in Number of Packs of Red Blood Cells (pRBC) Transfusions Over 8 WeeksOL Component (Cohort 2): Roxadustat 2.0 mg/kg3Participants
OL and OL High-EPO Components: Number of Participants Who Achieved TI ≥50% Reduction From Baseline in Number of Packs of Red Blood Cells (pRBC) Transfusions Over 8 WeeksOL Component (Cohort 3): Roxadustat 2.5 mg/kg7Participants
OL and OL High-EPO Components: Number of Participants Who Achieved TI ≥50% Reduction From Baseline in Number of Packs of Red Blood Cells (pRBC) Transfusions Over 8 WeeksOL High-EPO Component: Roxadustat 2.5 mg/kg8Participants
DB Component: Number of Participants Who Achieved TI ≥56 Consecutive Days Since First Dose in 52 Weeks of TreatmentDB Component: Roxadustat44Participants
DB Component: Number of Participants Who Achieved TI ≥56 Consecutive Days Since First Dose in 52 Weeks of TreatmentDB Component: Placebo23Participants
DB Component: Number of Participants Who Achieved TI ≥56 Consecutive Days Anytime During the StudyDB Component: Roxadustat52Participants
DB Component: Number of Participants Who Achieved TI ≥56 Consecutive Days Anytime During the StudyDB Component: Placebo29Participants
DB Component: Number of Participants Who Achieved ≥50% Reduction From Baseline in Number of pRBC Transfusions Over 8 WeeksDB Component: Roxadustat59Participants
DB Component: Number of Participants Who Achieved ≥50% Reduction From Baseline in Number of pRBC Transfusions Over 8 WeeksDB Component: Placebo37Participants
DB Component: Cumulative Number of Participant Exposure Weeks (PEW) of TI Over the First 28 Weeks of TreatmentDB Component: Roxadustat9.60Standard Deviation 11.537weeks
DB Component: Cumulative Number of Participant Exposure Weeks (PEW) of TI Over the First 28 Weeks of TreatmentDB Component: Placebo7.60Standard Deviation 11.557weeks
DB Component: Change From Baseline in Number of pRBC Packs Transfused Over the First 28 Weeks of TreatmentDB Component: Roxadustat-0.13Standard Deviation 2.314pRBC packs
DB Component: Change From Baseline in Number of pRBC Packs Transfused Over the First 28 Weeks of TreatmentDB Component: Placebo0.44Standard Deviation 1.833pRBC packs

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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