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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00416520
Recruitment Status : Completed
First Posted : December 28, 2006
Results First Posted : October 23, 2014
Last Update Posted : November 4, 2014
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Hyperphosphatemia Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) Drug: Placebo Drug: Another phosphate binder (Sevelamer) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Double-Blind, Multi-centre, Withdrawal Study Comparing MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
Study Start Date : June 2007
Primary Completion Date : November 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind
Placebo Comparator: 2 Drug: Placebo
3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
Active Comparator: 3 Drug: Another phosphate binder (Sevelamer)
Current approved dosing recommendations for 12 weeks

Primary Outcome Measures :
  1. Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2) [ Time Frame: week16 minus week12 ]
    ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.

Secondary Outcome Measures :
  1. Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1) [ Time Frame: week12 minus week0 ]
    ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female, 18 years of age or over
  • Clinically stable haemodialysis or peritoneal dialysis
  • Stable phosphate control
  • On a stabilised phosphorus diet
  • Female and of child-bearing potential have a negative serum pregnancy test.
  • Male subjects must agree to use appropriate contraception.

Exclusion Criteria:

  • Current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
  • Body Mass Index (BMI) <=16.0 kg/m2 or >=40.0 kg/m2
  • A current or history of significant gastrointestinal motility problems
  • A positive test for HIV 1 and 2 antibodies
  • A history of substance or alcohol abuse within the last year.
  • Seizure disorders
  • A history of drug or other allergy
  • A temporary catheter as a vascular access
  • Participated in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416520

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Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Principal Investigator: Professor Information at Mitsubishi Pharma Europe

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00416520     History of Changes
Other Study ID Numbers: MCI-196-E07
First Posted: December 28, 2006    Key Record Dates
Results First Posted: October 23, 2014
Last Update Posted: November 4, 2014
Last Verified: October 2014

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Chronic Kidney Disease
Phosphate binder

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action