Conditions: Chronic Kidney Disease Hyperphosphatemia
Keywords: Chronic Kidney Disease Dialysis Hyperphosphatemia Phosphate binder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 336
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) intervention 2: Placebo intervention 3: Another phosphate binder (Sevelamer)
Intervention descriptions: intervention 1: 3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind intervention 2: 3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind intervention 3: Current approved dosing recommendations for 12 weeks

Protocol document: