Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00542386
First received: October 10, 2007
Last updated: September 30, 2014
Last verified: September 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    The change from baseline to week 12

  • The Change in LDL-cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The percentage change from baseline to week 12


Secondary Outcome Measures:
  • The Change in Total-cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The Change in HDL-cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The Change in Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The Change in PTH [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The Change in Ca [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The Change in Ca x P Ion Product [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The Incidence of Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542386

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

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00542386     History of Changes
Other Study ID Numbers: MCI-196-E08
Study First Received: October 10, 2007
Results First Received: April 10, 2014
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration
Italy: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Macedonia: Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Ukraine: State Pharmacological Center - Ministry of Health
Hungary: National Institute of Pharmacy
Malaysia: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 20, 2014