A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia

• Change from baseline in serum phosphorus [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Change from baseline in PTH [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Change from baseline in Calcium [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Change from baseline in Calcium x phosphorus ion product [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Change from baseline in Total cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Change from baseline in LDL cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Change from baseline in HDL cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Change from baseline in VLDL cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Change from baseline in Triglyceride [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Incidence of adverse events [ Time Frame: 12 weeks and 4 weeks (12-16 weeks) ] [ Designated as safety issue: Yes ]

• The change in Total/LDL/HDL/VLDL cholesterol, Triglyceride, PTH, Calcium and Ca x P ion product
• The change in Safety parameters

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, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.

• Chronic Kidney Disease
• Dialysis
• Hyperphosphatemia

• Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)
  3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind
• Drug: Placebo
  3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind

• Experimental: 1
  Intervention: Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)
• Placebo Comparator: 2
  Intervention: Drug: Placebo

Inclusion Criteria:

• Male or female, and is >=18 years old
• Stable hemodialysis or peritoneal dialysis
• Subjects has Stable phosphate control
• Subjects on Stabilized phosphorus diet
• Subjects undergoing regular dialysis treatment
• 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.
• serum albumin level < 3.0g/dL
• PTH level > 1000pg/mL
• Hemoglobin level < 8mg/dL
• A History of significant gastrointestinal motility problems
• Biliary obstruction or proven liver dysfunction
• A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies
• A clinically significant severe lactose intolerance or sensitivity
• A history of substance or alcohol abuse within the last year.
• Seizure disorders
• A history of drug or other allergy
• using cholestyramine, colestipol or colesevelam
• Schedule to receive a kidney transplant within the next 6 months
• 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