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A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis 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. Identifier: NCT00506441
Recruitment Status : Completed
First Posted : July 25, 2007
Results First Posted : July 25, 2014
Last Update Posted : September 15, 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, flexible dose titration, 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 Dialysis Hyperphosphatemia Drug: MCI-196 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-center, Withdrawal Study Comparing MCI-196 v.s Placebo Following A 12-Week Dose Titration Period With MCI-196 in Stage V Subjects on Dialysis With Hyperphosphatemia
Study Start Date : September 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: 1 Drug: MCI-196
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose (Open-label) and 4 weeks of double blind
Other Names:
  • Colestilan(INN)
  • Colestimide(JAN)
  • BindRen®

Placebo Comparator: 2 Drug: Placebo
3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind

Primary Outcome Measures :
  1. The Change in Serum Phosphorus From Week 12 to Week 16 [ Time Frame: 4 weeks (Week 12 to Week 16) ]
    The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)

Secondary Outcome Measures :
  1. Change From Baseline in Serum Phosphorus [ Time Frame: 12 weeks (Week 0 to Week 12) ]
  2. Change From Baseline in PTH [ Time Frame: 12 weeks ]
  3. Change From Baseline in Calcium [ Time Frame: 12 weeks ]
  4. Change From Baseline in Calcium x Phosphorus Ion Product [ Time Frame: 12 weeks ]
  5. Change From Baseline in Total Cholesterol [ Time Frame: 12 weeks ]
  6. Change From Baseline in LDL Cholesterol [ Time Frame: 12 weeks ]
  7. Change From Baseline in HDL Cholesterol [ Time Frame: 12 weeks ]
  8. Change From Baseline in VLDL Cholesterol [ Time Frame: 12 weeks ]
  9. Change From Baseline in Triglyceride [ Time Frame: 12 weeks ]
  10. Incidence of Adverse Events [ Time Frame: 12 weeks (Week 0-12) and 4 weeks (Week 12-16) ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Male or female, and is >=18 years old
  • Stable hemodialysis or peritoneal dialysis
  • Subjects has Stable phosphate control
  • Subjects on Stabilized phosphorus diet
  • Subjects undergoing regular dialysis treatment
  • 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.
  • serum albumin level < 3.0g/dL
  • PTH level > 1000pg/mL
  • Hemoglobin level < 8mg/dL
  • A History of significant gastrointestinal motility problems
  • Biliary obstruction or proven liver dysfunction
  • A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies
  • A clinically significant severe lactose intolerance or sensitivity
  • A history of substance or alcohol abuse within the last year.
  • Seizure disorders
  • A history of drug or other allergy
  • using cholestyramine, colestipol or colesevelam
  • Schedule to receive a kidney transplant within the next 6 months
  • Participation 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 identifier (NCT number): NCT00506441

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mitsubishi Tanabe Pharma Corporation Identifier: NCT00506441     History of Changes
Other Study ID Numbers: MCI-196-A05
First Posted: July 25, 2007    Key Record Dates
Results First Posted: July 25, 2014
Last Update Posted: September 15, 2014
Last Verified: September 2014
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Chronic Kidney Disease
Phosphate binder
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases
Bile Acids and Salts
Gastrointestinal Agents