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Trial · NCT02075463

Outcomes22

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARY
Percentage of Participants Demonstrating an Increase in Hgb of >=1 g/dL (if Baseline Hgb is <9.5 g/dL), or >=0.5 g/dL (if Baseline Hgb is 9.5-<10 g/dL), or Stay Within Target Range and do Not Drop by >0.5 g/dL (if Baseline Hgb is >= 10 g/dL) at Week 16
Week 16ITT population: participants who received at least one dose of drug, have a baseline Hgb and at least one corresponding on treatment Hgb assessment.Percentage of participantsNUMBER
SECONDARYChange From Baseline in Hgb Levels at Week 16Week 16ITT population.g/dLMEAN
SECONDARYPercentage of Time (Days) Hgb Levels Within, Below and Above Target Range at the Indicated Time PointWeek 12 to Week 16ITT population.Percentage of daysMEAN
SECONDARYNumber of Participants Achieving at Least 1 g/dL Increase in Hgb From Baseline at Week 16Baseline and Week 16ITT population.ParticipantsNUMBER
SECONDARYNumber of Participants With Hgb in the Target Range at Week 16Week 16ITT populationParticipantsNUMBER
SECONDARYNumber of Participants Reaching Pre-defined Hgb Stopping CriteriaUp to Week 16ITT populationParticipantsNUMBER
SECONDARYPercent Change From Baseline in Hepcidin at Week 16Baseline (Day 1) and Week 16ITT populationPercent change in hepcidinGEOMETRIC_MEAN
SECONDARYChange From Baseline in Ferritin at Week 16Baseline (Day 1) and Week 16ITT populationMicrograms/LiterMEAN
SECONDARYChange From Baseline in Transferrin at Week 16Baseline (Day 1) and Week 16ITT populationPercent changeMEAN
SECONDARYPercent Change From Baseline in Transferrin Saturation at Week 16Baseline (Day 1) and Week 16ITT populationPercent change in transferrinGEOMETRIC_MEAN
SECONDARYChange From Baseline in Total Iron at Week 16Baseline (Day 1) and Week 16ITT populationMicromoles (µmol)/LNUMBER
SECONDARYChange From Baseline in Total Iron Binding Capacity (TIBC) at Week 16Baseline (Day 1) and Week 16ITT populationµmol/ LNUMBER
SECONDARYReticulocyte Hgb Content (CHr) at Week 16Week 16Safety population consisted of all participants who received at least one dose of study drugPicogram (pg)NUMBER
SECONDARYMean Corpuscular Volume (MCV) at Week 16Week 16Safety populationFemtoliter (fL)NUMBER
SECONDARYMean Corpuscular Hemoglobin (MCH) at Week 16Week 16Safety populationpgNUMBER
SECONDARYChange From Baseline in Hematocrit at Week 16Baseline (Day 1) and Week 16ITT populationFraction of 1NUMBER
SECONDARYChange From Baseline in Red Blood Cell (RBC) at Week 16Baseline (Day 1) and Week 16ITT population10^12/LNUMBER
SECONDARYChange From Baseline in Reticulocyte Number at Week 16Baseline (Day 1) and Week 16ITT population10^12/LNUMBER
SECONDARYMaximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)Baseline (Day 1) to Week 16ITT populationPercent changeGEOMETRIC_MEAN
SECONDARYMaximum Observed Change From Baseline in Erythropoietin (EPO)Baseline (Day 1) to Week 16ITT populationinternational units(IU)/Liter (L)MEAN

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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