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Trial · NCT02652819

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Hb from baseline to the average levelWeeks 7 to 9 inclusive.Change in Hb from baseline to the average level
SecondaryThe proportion of subjects who achieve a confirmed Hb responseup to and including Week 9The proportion of subjects who achieve a confirmed Hb response
SecondaryProportion of subjects with mean Hb ≥10.0 g/dLWeeks 7 to 9Proportion of subjects with mean Hb ≥10.0 g/dL
SecondaryMean change from baseline in low-density lipoprotein (LDL) cholesterol averagedWeeks 7 to 9Mean change from baseline in low-density lipoprotein (LDL) cholesterol averaged
SecondaryEffect on iron metabolismWeek 9Measurement of serum iron
SecondarySurvey (SF-36) Physical Functioning (PF) subscore measured in Week 9 in the Full Analysis Set (FAS) subjects with baseline PF subscore below 35Week 9Survey (SF-36) Physical Functioning (PF) subscore measured in Week 9 in the Full Analysis Set (FAS) subjects with baseline PF subscore below 35
SecondaryMean change from baseline in SF-36 vitality subscore measured in Week 9 in FAS subjects with baseline vitality subscore below 50.Week 9Mean change from baseline in SF-36 vitality subscore measured in Week 9 in FAS subjects with baseline vitality subscore below 50.
SecondaryMean change from baseline in mean arterial blood pressureWeeks 7 to 9Mean change from baseline in mean arterial blood pressure
SecondaryProportion of subjects who received rescue therapy (composite of blood transfusion, ESA use, and IV iron)Up to Week 9Proportion of subjects who received rescue therapy (composite of blood transfusion, ESA use, and IV iron)
SecondaryPercent of subjects with treatment-emergent adverse events (TEAEs).Week 1 up to Week 53Percent of subjects with treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
SecondaryNumber of subjects with treatment-emergent adverse events (TEAEs).Week 1 up to Week 53Number of subjects with treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
SecondaryChanges from baseline in vital signsWeek 1 up to Week 53Measurement of vital signs
SecondaryChanges from baseline in ECG findingsWeek 1 up to Week 53ECG recordings
SecondaryChanges from baseline in clinical laboratory valuesWeek 1 up to Week 53Clinical laboratory values
SecondaryProportion of subjects on rescue therapyWeek 1 up to Week 53Proportion of subjects on rescue therapy
SecondaryTime to rescue therapy from date of first doseWeek 1 up to Week 53Time to rescue therapy from date of first dose

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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