A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv15
  2. Interventions: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) (Drug), Placebo (Drug) to MCI-196 (Drug), Placebo (Drug)v14
  3. Results first posted: Jul 25, 2014
    • Primary endpoint revised
    • Secondary endpoints revised (10)
    v13
  4. Re-verified, no change to tracked fieldsv12
  5. Enrollment target: estimated 200 to confirmed 245v11
Show 9 earlier versionsHide 9 earlier versions
  1. Secondary endpoints: 2 to 10v10
  2. Re-verified, no change to tracked fieldsv9
  3. Eligibility criteria revisedv8
  4. Trial status: Active, Not Recruiting to Completedv7
  5. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 22 to 39
    • Primary and study completion dates: Jul 2009 to Sep 2009
    v6
  6. Primary and study completion dates: Jun 2008 to Jul 2009
    • Eligibility criteria revised
    v5
  7. Study sites: 21 to 22v4
  8. Study sites: 11 to 21v3 Show 4 more changesShow less
    • Primary and study completion dates: Jun 2008
    • Interventions: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) (Drug) to MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) (Drug), Placebo (Drug)
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study arms: 0 to 2
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 11
    • Start date: Sep 2007
    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, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.
Trial Details
NCT Number NCT00506441
Lead Sponsor Tanabe Pharma Corporation
Conditions
(from sponsor)		 Chronic Kidney Disease, Dialysis, Hyperphosphatemia
Related terms Hyperphosphatemia, Renal Insufficiency, Chronic
Enrollment 245 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov