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A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv14
  2. Secondary endpoints: details revised at 1 of 1 entryv13
  3. Results first posted: Oct 23, 2014 Primary endpoint revised · Enrollment target: 333 to 336 · Interventions: Another phosphate binder (Drug), MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) (Drug), Placebo (Drug) to Another phosphate binder (Sevelamer) (Drug), MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) (Drug), Placebo (Drug) · 1 morev12 Show 4 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 333 to 336
    • Interventions: Another phosphate binder (Drug), MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) (Drug), Placebo (Drug) to Another phosphate binder (Sevelamer) (Drug), MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) (Drug), Placebo (Drug)
    • Secondary endpoints: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  4. Enrollment target: estimated 320 to confirmed 333v11
  5. Trial status: Active, Not Recruiting to Completedv10
Show 8 earlier versionsHide 8 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Study sites: 28 to 68 · Primary and study completion dates: Oct 2009 to Nov 2009v9 Show 2 more changesShow less
    • Study sites: 28 to 68
    • Primary and study completion dates: Oct 2009 to Nov 2009
  2. Primary and study completion dates: Jun 2008 to Oct 2009 Eligibility criteria shortened, about 8 wordsv8 Show 1 more changeShow less
    • Eligibility criteria shortened, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 31 to 28v7
  4. Primary and study completion dates: Feb 2008 to Jun 2008v6
  5. Study sites revised (31)v5 See this version in full on ClinicalTrials.gov ↗
  6. Study sites: 7 to 31 Primary and study completion dates: Feb 2008 · Interventions: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) (Drug) to Another phosphate binder (Drug), MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) (Drug), Placebo (Drug) · Secondary endpoints: details revised at 2 of 2 entries · 2 morev4 Show 5 more changesShow less
    • Primary and study completion dates: Feb 2008
    • Interventions: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) (Drug) to Another phosphate binder (Drug), MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) (Drug), Placebo (Drug)
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study arms: 0 to 3
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  7. Trial status: Not Yet Recruiting to Recruiting Study sites: 4 to 7 · Start date: Jun 2007 · Interventions: MCI-196 (Drug) to MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) (Drug) · 1 morev3 Show 4 more changesShow less
    • Study sites: 4 to 7
    • Start date: Jun 2007
    • Interventions: MCI-196 (Drug) to MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) (Drug)
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  8. Eligibility criteria revised Study title expanded, about 1 wordv2 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, randomised, parallel group, flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.
Trial Details
NCT Number NCT00416520
Lead Sponsor Tanabe Pharma Corporation
Conditions Chronic Kidney Disease, Hyperphosphatemia
Enrollment 336 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov