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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00506441
First received: July 24, 2007
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Chronic Kidney Disease
Dialysis
Hyperphosphatemia
 Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • The change in serum phosphorus levels for MCI-196 and placebo [ Time Frame: 4 weeks (12-16 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in serum phosphorus [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in PTH [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Calcium [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Calcium x phosphorus ion product [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Total cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in LDL cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in HDL cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in VLDL cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Triglyceride [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 12 weeks and 4 weeks (12-16 weeks) ] [ Designated as safety issue: Yes ]

Enrollment: 245
Study Start Date: September 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00506441

  Show 39 Study Locations
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Principal Investigator: Professor Information at Mitsubishi Pharma America
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00506441     History of Changes
Other Study ID Numbers: MCI-196-A05
Study First Received: July 24, 2007
Last Updated: February 26, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Kidney Diseases
Hyperphosphatemia
Renal Insufficiency, Chronic
Kidney Failure, Chronic
 Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on June 13, 2013