Conditions: Chronic Kidney Disease Dialysis Hyperphosphatemia
Keywords: Chronic Kidney Disease Dialysis Hyperphosphatemia
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 632
Healthy volunteers: no

Brief summary:
This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks

Detailed description:
Following completion of one of the Phase III studies (E07, E08 or E09) eligible patients will receive either MCI-196 for up to 52 weeks. The study is in two periods. The initial period allows flexible dosing for a period of 8 weeks. This will allow subjects to achieve individually optimised doses. After 8 weeks, subjects will continue flexible dosing with MCI-196 but with titration intervals every 4 weeks instead of every 2 weeks. Subjects previously exposed to MCI-196 will end the study at Week 40.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: MCI-196 intervention 2: Another Phosphate binder (Sevelamer)
Intervention descriptions: intervention 1: 3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose intervention 2: Current approved dosing recommendations for 12 weeks

Protocol document: