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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
245
The Change in Serum Phosphorus From Week 12 to Week 16
The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)
Time frame: 4 weeks (Week 12 to Week 16)
Change From Baseline in Serum Phosphorus
Time frame: 12 weeks (Week 0 to Week 12)
Change From Baseline in PTH
Time frame: 12 weeks
Change From Baseline in Calcium
Time frame: 12 weeks
Change From Baseline in Calcium x Phosphorus Ion Product
Time frame: 12 weeks
Change From Baseline in Total Cholesterol
Time frame: 12 weeks
Change From Baseline in LDL Cholesterol
Time frame: 12 weeks
Change From Baseline in HDL Cholesterol
Time frame: 12 weeks
Change From Baseline in VLDL Cholesterol
Time frame: 12 weeks
Change From Baseline in Triglyceride
Time frame: 12 weeks
Incidence of Adverse Events
Time frame: 12 weeks (Week 0-12) and 4 weeks (Week 12-16)
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Glendale, Arizona, United States
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Tempe, Arizona, United States
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Hot Springs, Arkansas, United States
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Paragould, Arkansas, United States
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Pine Bluff, Arkansas, United States
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Fountain Valley, California, United States
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La Mesa, California, United States
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Long Beach, California, United States
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Lynwood, California, United States
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Orange, California, United States
...and 29 more locations