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Trial · NCT03543657

Registered outcomes17

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

ListOutcomeTime frameDescription
PrimaryThe mean Hb level during the evaluation periodFrom week 33 to 36
PrimaryThe change in mean Hb level during the evaluation period from baselineBaseline and week 33 to 36
SecondaryResponder rate: proportion of responders among the subjectsFrom week 33 to 36Responder is defined as meeting all of the following criteria: (i) Mean of the Hb levels in the target range (ii) ≥ 50% of the Hb levels in the target range (iii) No rescue treatment
SecondaryProportion of subjects who meet each component of the responseFrom week 33 to 36Response: (i) Mean of the Hb levels in the target range (ii) ≥ 50% of the Hb levels in the target range (iii) No rescue treatment
SecondaryHb levelUp to 52 weeks
SecondaryChange in Hb levelBaseline and up to 52 weeks
SecondaryProportion of subjects whose mean hemoglobin level is in the target rangeFrom week 33 to 36
SecondaryProportion of subjects whose mean hemoglobin level is above the target rangeFrom week 33 to 36
SecondaryProportion of subjects whose mean hemoglobin level is below the target rangeFrom week 33 to 36
SecondaryProportion of subjects with hemoglobin levels in the target rangeUp to 52 weeks
SecondaryProportion of subjects with hemoglobin levels above the target rangeUp to 52 weeks
SecondaryProportion of subjects with hemoglobin levels below the target rangeUp to 52 weeks
SecondaryProportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/weekUp to 52 weeksDefined as change in Hb level / duration between two visits (weeks)
SecondaryNumber of participants with serious adverse eventsUp to 52 weeks
SecondaryMaximum concentration (Cmax)At baseline, week 8, week 24 and week 52
SecondaryArea under the concentration-time curve (AUC)At baseline, week 8, week 24 and week 52
SecondaryEPO (Erythropoietin) serum concentrationAt baseline, week 8, week 24 and week 52

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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GET https://conductscience.org/api/trials/v1/NCT03543657/registered