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

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease

Treatments: Drug: Placebo of MCI-196; Drug: Placebo of Simvastatin; Drug: MCI-196; Drug: Simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00858637

MCI-196-E11

Details and patient eligibility

About

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.

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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260 participants in 4 patient groups, including a placebo group

1 MCI-196

Experimental group

Treatment:

Drug: Placebo of Simvastatin

Drug: MCI-196

2 Placebo of MCI-196

Placebo Comparator group

Treatment:

Drug: Placebo of Simvastatin

Drug: Placebo of MCI-196

3 Simvastatin

Active Comparator group

Treatment:

Drug: Simvastatin

Drug: Placebo of MCI-196

4 Placebo of Simvastatin

Placebo Comparator group

Treatment:

Drug: Placebo of Simvastatin

Drug: Placebo of MCI-196