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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: NCT00772382
Recruitment Status : Completed
First Posted : October 15, 2008
Results First Posted : May 12, 2014
Last Update Posted : September 15, 2014
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Description
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Brief Summary:

The primary objective of this study is to demonstrate the long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia.

The secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Dialysis Hyperphosphatemia Drug: MCI-196 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Multi-center, 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 : December 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MCI-196 Drug: MCI-196
3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose
Other Names:
  • Colestilan(INN)
  • Colestimide(JAN)
  • CHOLEBINE®
  • BindRen®


Outcome Measures
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Primary Outcome Measures :
  1. Number of Adverse Events (AE) [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. The Change in Serum Phosphorus From Baseline to Week 52 [ Time Frame: 52 weeks ]

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

Inclusion Criteria:

  • Male or female, and is >=18 years old
  • Stable hemodialysis or peritoneal dialysis
  • Subjects have stable phosphate control
  • Subjects on stabilized phosphorus diet
  • Subjects undergoing regular dialysis treatment
  • Females 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 him/her 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/L
  • 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 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
  • 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
Contacts and Locations
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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): NCT00772382


Locations
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United States, California
Los Angeles, California, United States
Orange, California, United States
Tarzana, California, United States
United States, Florida
Orlando, Florida, United States
Pembroke Pines, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Gurnee, Illinois, United States
United States, Indiana
Evansville, Indiana, United States
United States, Louisiana
Baton Rouge, Louisiana, United States
New Orleans, Louisiana, United States
United States, New York
Northport, New York, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Houston, Texas, United States
United States, Vermont
Burlington, Vermont, United States
United States, Virginia
Chesapeake, Virginia, United States
Canada, British Columbia
Kamloops, British Columbia, Canada
Canada, Ontario
London, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Principal Investigator: Professor Information at Mitsubishi Pharma America
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00772382    
Other Study ID Numbers: MCI-196-A06
First Posted: October 15, 2008    Key Record Dates
Results First Posted: May 12, 2014
Last Update Posted: September 15, 2014
Last Verified: September 2014
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Chronic Kidney Disease
Dialysis
Hyperphosphatemia
Phosphate binder
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hyperphosphatemia
Urologic Diseases
 Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases