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

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