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

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv14
  2. Secondary endpoints: details revised at 1 of 1 entryv13
  3. Results first posted: Oct 23, 2014v12 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
  4. Enrollment target: estimated 320 to confirmed 333v11
  5. Trial status: Active, Not Recruiting to Completedv10
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  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 28 to 68
    • Primary and study completion dates: Oct 2009 to Nov 2009
    v9
  2. Primary and study completion dates: Jun 2008 to Oct 2009
    • Eligibility criteria shortened, about 8 words
    v8
  3. Study sites: 31 to 28v7
  4. Primary and study completion dates: Feb 2008 to Jun 2008v6
  5. Study sites revised (31)v5
  6. Study sites: 7 to 31v4 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
  7. Trial status: Not Yet Recruiting to Recruitingv3 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
  8. Eligibility criteria revised
    • Study title expanded, about 1 word
    v2
  1. Study First Submitted
  • 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
(from sponsor)		 Chronic Kidney Disease, Hyperphosphatemia
Related terms Hyperphosphatemia, Renal Insufficiency, Chronic
Enrollment 336 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov