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A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects 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.
ClinicalTrials.gov Identifier: NCT00542815
Recruitment Status : Completed
First Posted : October 12, 2007
Results First Posted : September 23, 2014
Last Update Posted : October 2, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Dialysis Hyperphosphatemia Drug: MCI-196 Drug: Another Phosphate binder (Sevelamer) Phase 3

Detailed Description:
Following completion of one of the Phase III studies (E07, E08 or E09) eligible patients will receive either MCI-196 for up to 52 weeks. The study is in two periods. The initial period allows flexible dosing for a period of 8 weeks. This will allow subjects to achieve individually optimised doses. After 8 weeks, subjects will continue flexible dosing with MCI-196 but with titration intervals every 4 weeks instead of every 2 weeks. Subjects previously exposed to MCI-196 will end the study at Week 40.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 632 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Multicentre, Open Label, Flexible Dose, Long Term Safety Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
Study Start Date : November 2007
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Sevelamer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: MCI-196
3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose
Other Names:
  • Colestilan(INN)
  • Colestimide(JAN)
  • BindRen®
Active Comparator: 2 Drug: Another Phosphate binder (Sevelamer)
Current approved dosing recommendations for 12 weeks

Outcome Measures

Primary Outcome Measures :
  1. The Change in Serum Phosphorus for MCI-196 and Sevelamer [ Time Frame: 52 weeks (Baseline-52 weeks) ]
    Change from Baseline to Week 52 (LOCF)

Secondary Outcome Measures :
  1. The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer [ Time Frame: 52 weeks (Baseline-52 weeks) ]
    Percent Change from Baseline to Week 52 (LOCF)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinically stable haemodialysis or peritoneal dialysis treatment.
  • Stable phosphate control
  • Stabilised phosphorus diet.
  • female subjects of child-bearing potential must have a negative serum pregnancy test.
  • Male subjects must agree to use appropriate contraception.
  • Completed one of the MCI-196 PIII studies

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.
  • Current or a history of significant gastrointestinal motility problems
  • Positive test for HIV 1 and 2 antibodies.
  • History of substance or alcohol abuse within the last year.
  • Seizure disorders.
  • History of drug or other allergy.
  • Temporary catheter with active signs of inflammation or infection.
  • The subject has participated in a clinical study with any experimental medication (with the exception of MCI-196 PIII studies) in the last 30days or experimental biological product within the 90 days prior to signing of informed consent form.
Contacts and Locations

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): NCT00542815

  Show 115 Study Locations
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Principal Investigator: Professor Information at Mitsubishi Pharma Europe
More Information

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00542815     History of Changes
Other Study ID Numbers: MCI-196-E10
First Posted: October 12, 2007    Key Record Dates
Results First Posted: September 23, 2014
Last Update Posted: October 2, 2014
Last Verified: September 2014

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Chronic Kidney Disease

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