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A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00542386
First Posted: October 11, 2007
Last Update Posted: October 6, 2014
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.
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
  Purpose
This is a phase III multi-centre study in two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.

Condition Intervention Phase
Chronic Kidney Disease Dialysis Hyperphosphatemia Dyslipidemia Drug: MCI-196 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multi-centre, Double-blind, Randomised, Placebo-controlled Multiple Fixed-dose Study of MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia (Incorporating Two Parallel High Dose Groups)

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • The Change in Serum Phosphorus [ Time Frame: 12 weeks ]
    The change from baseline to week 12

  • The Change in LDL-cholesterol [ Time Frame: 12 weeks ]
    The percentage change from baseline to week 12


Secondary Outcome Measures:
  • The Change in Total-cholesterol [ Time Frame: 12 weeks ]
  • The Change in HDL-cholesterol [ Time Frame: 12 weeks ]
  • The Change in Triglycerides [ Time Frame: 12 weeks ]
  • The Change in PTH [ Time Frame: 12 weeks ]
  • The Change in Ca [ Time Frame: 12 weeks ]
  • The Change in Ca x P Ion Product [ Time Frame: 12 weeks ]
  • The Incidence of Adverse Events [ Time Frame: 12 weeks ]

Enrollment: 642
Study Start Date: December 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MCI-196
3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study
Other Names:
  • Colestilan(INN),
  • Colestimide(JAN)
  • CHOLEBINE®
  • BindRen®
Placebo Comparator: 2 Drug: Placebo
3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study

  Eligibility

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
Criteria

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.
  • A a serum albumin level<30.0g/L
  • A PTH level >1000pg/mL
  • A body mass index (BMI)<= 16.0kg/㎡ or =>40.0kg/㎡
  • A serum LDL-C level >4.94mmol/L(190mg/dL)
  • A serum triglycerides level >6.76mmol/L (600mg/dL)
  • A 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
  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): NCT00542386


  Show 73 Study Locations
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Principal Investigator: Professor Information at Mitsubishi Pharma Europe
  More Information

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00542386     History of Changes
Other Study ID Numbers: MCI-196-E08
First Submitted: October 10, 2007
First Posted: October 11, 2007
Results First Submitted: April 10, 2014
Results First Posted: October 6, 2014
Last Update Posted: October 6, 2014
Last Verified: September 2014

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

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