Trial record 1 of 1 for:    NCT00858637
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Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00858637
First received: March 9, 2009
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

The primary objective of this study is to demonstrate the superiority of MCI-196 over placebo and non-inferiority with simvastatin in reducing serum low-density lipoprotein (LDL)-cholesterol in subjects with chronic kidney disease Stage V on dialysis. This study incorporates a Washout Period and two treatment periods - an active comparison phase and a placebo-controlled withdrawal phase.


Condition Intervention Phase
Chronic Kidney Disease
Drug: MCI-196
Drug: Placebo of Simvastatin
Drug: Simvastatin
Drug: Placebo of MCI-196
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, Multicentre, Double-blind, Double-dummy, Randomised, Flexible-dose, Comparative Study of MCI-196 Versus Simvastatin for the Treatment of Dyslipidaemia in Subjects With Chronic Kidney Disease on Dialysis (Incorporating a Placebo-controlled Withdrawal Phase)

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Change in LDL-cholesterol [ Time Frame: 16 weeks and 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in total cholesterol, high-density lipoprotein cholesterol (HDL-C), triglycerides and additional lipid parameters [ Time Frame: 16 weeks and 20 weeks ] [ Designated as safety issue: No ]
  • Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus ion product(PxCa) and parathyroid hormone (PTH) [ Time Frame: 16 weeks and 20 weeks ] [ Designated as safety issue: No ]
  • Vital signs, adverse events, and laboratory values [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 260
Study Start Date: March 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 MCI-196 Drug: MCI-196
Tablets of 3 g to 12 g/day (3 times a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)
Other Names:
  • Colestilan(INN)
  • Colestimide(JAN)
  • CHOLEBINE®)
Drug: Placebo of Simvastatin
Tablets once a day, for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)
Placebo Comparator: 2 Placebo of MCI-196 Drug: Placebo of Simvastatin
Tablets once a day, for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)
Drug: Placebo of MCI-196
Tablets 3 times a day for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)
Active Comparator: 3 Simvastatin Drug: Simvastatin
Tables of 10 mg to 40 mg/day (once a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)
Drug: Placebo of MCI-196
Tablets 3 times a day for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)
Placebo Comparator: 4 Placebo of Simvastatin Drug: Placebo of Simvastatin
Tablets once a day, for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)
Drug: Placebo of MCI-196
Tablets 3 times a day for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)

  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 undergoing regular dialysis treatment
  • If 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 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 < 30 g/L
  • Triglycerides level > 6.76 mmol/L (600 mg/dL)
  • LDL-cholesterol level > 4.94 mmol/L (190 mg/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
  • The subject has a history of rhabdomyolysis or myopathy
  • Schedule to receive a kidney transplant within the next 6 months
  • The subject has porphyria
  • 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
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: NCT00858637

  Show 39 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: NCT00858637     History of Changes
Other Study ID Numbers: MCI-196-E11
Study First Received: March 9, 2009
Last Updated: February 27, 2013
Health Authority: Singapore: Health Sciences Authority
Belarus: Ministry of Health
Malaysia: Ministry of Health
Bulgaria: Ministry of Health
Croatia: Ministry of Health and Social Care
Denmark: Danish Medicines Agency
Indonesia: National Agency of Drug and Food Control
Israel: Ministry of Health
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Romania: Ministry of Public Health
Thailand: Food and Drug Administration

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Chronic Kidney Disease
Dialysis
Dyslipidemia
Bile acid sequestrant

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Dyslipidemias
Urologic Diseases
Renal Insufficiency
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014