Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Dyslipidemias
Intervention: MCI-196; Placebo of Simvastatin; Simvastatin; Placebo of MCI-196
Intervention description: 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); 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); 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); 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 MeSH terms: Bile Acids and Salts; Simvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease; Dialysis; Dyslipidemia; Bile acid sequestrant

Summary:

      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.
    

Eligibility 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