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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
336
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind
3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
Current approved dosing recommendations for 12 weeks
Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)
ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.
Time frame: week16 minus week12
Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)
ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.
Time frame: week12 minus week0
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Adelaide, Australia
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Nedlands, Australia
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Parkville, Australia
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St Leonards, Australia
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Sydney, Australia
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Woolloongabba, Australia
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Graz, Austria
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Frýdek-Místek, Czechia
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HradecKralove, Czechia
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Ostrava, Czechia
...and 58 more locations