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

NCT ID: NCT00858637

Last Updated: 2014-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Disease

Keywords

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Chronic Kidney Disease Dialysis Dyslipidemia Bile acid sequestrant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1 MCI-196

Group Type EXPERIMENTAL

MCI-196

Intervention Type DRUG

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)

Placebo of Simvastatin

Intervention Type DRUG

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)

2 Placebo of MCI-196

Group Type PLACEBO_COMPARATOR

Placebo of Simvastatin

Intervention Type DRUG

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 of MCI-196

Intervention Type DRUG

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)

3 Simvastatin

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

Tablets 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)

Placebo of MCI-196

Intervention Type DRUG

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)

4 Placebo of Simvastatin

Group Type PLACEBO_COMPARATOR

Placebo of Simvastatin

Intervention Type DRUG

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 of MCI-196

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type 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)

Intervention Type DRUG

Simvastatin

Tablets 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)

Intervention Type 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)

Intervention Type DRUG

Other Intervention Names

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Colestilan(INN) Colestimide(JAN) CHOLEBINE® BindRen®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Professor

Role: PRINCIPAL_INVESTIGATOR

Information at Mitsubishi Pharma Europe

Locations

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Brest, , Belarus

Site Status

Grodno, , Belarus

Site Status

Homyel, , Belarus

Site Status

Minsk, , Belarus

Site Status

Vitebsk, , Belarus

Site Status

Gabrovo, , Bulgaria

Site Status

Plovdiv, , Bulgaria

Site Status

Sofia, , Bulgaria

Site Status

Karlovac, , Croatia

Site Status

Osijek, , Croatia

Site Status

Esbjerg, , Denmark

Site Status

Roskilde, , Denmark

Site Status

Jakarta, , Indonesia

Site Status

Malang, , Indonesia

Site Status

Medan, , Indonesia

Site Status

Palembang, , Indonesia

Site Status

Tamanlarea Makassar, , Indonesia

Site Status

Ashkelon, , Israel

Site Status

Nahariya, , Israel

Site Status

Bellano, , Italy

Site Status

Catania, , Italy

Site Status

Lecco, , Italy

Site Status

Merate, , Italy

Site Status

Milan, , Italy

Site Status

Oggiono, , Italy

Site Status

Riga, , Latvia

Site Status

Valmiera, , Latvia

Site Status

Kaunas, , Lithuania

Site Status

Kedauniai, , Lithuania

Site Status

Vilnius, , Lithuania

Site Status

George Town, , Malaysia

Site Status

Johor Bahru, , Malaysia

Site Status

Kelantan, , Malaysia

Site Status

Perak, , Malaysia

Site Status

Bucharest, , Romania

Site Status

Timișoara, , Romania

Site Status

Singapore, , Singapore

Site Status

Bangkok, , Thailand

Site Status

Phitsanulok, , Thailand

Site Status

Countries

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Germany Belarus Bulgaria Croatia Denmark Indonesia Israel Italy Latvia Lithuania Malaysia Romania Singapore Thailand

Other Identifiers

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MCI-196-E11

Identifier Type: -

Identifier Source: org_study_id