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
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
632
3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose
Current approved dosing recommendations for 12 weeks
The Change in Serum Phosphorus for MCI-196 and Sevelamer
Change from Baseline to Week 52 (LOCF)
Time frame: 52 weeks (Baseline-52 weeks)
The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer
Percent Change from Baseline to Week 52 (LOCF)
Time frame: 52 weeks (Baseline-52 weeks)
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Graz, Austria
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Frýdek-Místek, Czechia
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Hradec Králové, Czechia
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Ostrava, Czechia
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Prague, Czechia
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Tábor, Czechia
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Ústí nad Labem, Czechia
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Bordeaux, France
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Montpelier, France
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Paris, France
...and 105 more locations