A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia

A Phase III, Multi-centre, Double-blind, Randomised, Placebo-controlled Multiple Fixed-dose Study of MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia (Incorporating Two Parallel High Dose Groups)

This is a phase III multi-centre study in two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.

Inclusion Criteria:

• Male or female, 18 years of age or over
• Clinically stable haemodialysis or peritoneal dialysis
• Stable phosphate control
• On a stabilised phosphorus diet
• 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 them 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.
• A a serum albumin level<30.0g/L
• A PTH level >1000pg/mL
• A body mass index (BMI)<= 16.0kg/㎡ or =>40.0kg/㎡
• A serum LDL-C level >4.94mmol/L(190mg/dL)
• A serum triglycerides level >6.76mmol/L (600mg/dL)
• A History of significant gastrointestinal motility problems
• A positive test for HIV 1 and 2 antibodies
• A history of substance or alcohol abuse within the last year
• Seizure disorders
• A history of drug or other allergy
• A temporary catheter as a vascular access
• Participated 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