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Trial · NCT04771780

Registered outcomes14

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

ListOutcomeTime frameDescription
PrimaryIncidence rates of all adverse events and adverse drug reactions that occurred or worsened after the initiation of KHK7791 treatment for 52 weeks.Dose period Week 1~52To investigate the safety of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in Hemodialysis patients with hyperphosphatemia.
SecondaryAchievement of at least 30% change of the total number of daily prescription tablets of phosphorus binders and KHK7791 from baseline in the last 3 weeks of the final assessment.Week 1~52
To investigate the efficacy of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in hyperphosphatemic subjects undergoing hemodialysis. Important secondary endpoint
SecondaryTotal daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.Week 1~52
SecondaryAchievement of at least 30% change of the total number of daily prescription tablets of phosphorus binders and KHK7791 from baseline, at each time point after the start of treatment.Week 1~52
SecondaryThe change of total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.Week 1~52
SecondaryThe rate of change of total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.Week 1~52
SecondaryConcentration of serum phosphorous levels values at each time point.Week 1~52
SecondaryChange of serum phosphorous levels from baseline values at each time point.Week 1~52
SecondaryAchievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 6.0).Week 1~52
SecondaryTime when the target serum phosphorus level (serum phosphorus level: ≤ 6.0) was achieved.Week 1~52
SecondaryAchievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 5.5).Week 1~52
SecondaryTime when the target serum phosphorus level (serum phosphorus level: ≤ 5.5) was achieved.Week 1~52
SecondaryConcentrations of such as Ca × P product levels at each time point.Week 1~52
SecondaryChanges of such as Ca × P product levels from baseline values at each time point.Week 1~52

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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