A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia

A Phase III, Randomised, Double-Blind, Multi-centre, Withdrawal Study Comparing MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, randomised, parallel group, flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 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.
• Body Mass Index (BMI) <=16.0 kg/m2 or >=40.0 kg/m2
• A current or 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