At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 642 enrolled
Drug / intervention
MCI-196 +1 moredrug
Likely dose
MCI-196 3gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multi-centre, Double-blind, Randomised, Placebo-controlled Multiple Fixed-dose Study of MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia (Incorporating Two Parallel High Dose Groups)
In Brief
A Phase 3 clinical trial evaluating MCI-196 and Placebo for Chronic Kidney Disease and 3 related conditions. Completed, enrolled 642 participants across 73 sites in 8 countries.
Detailed Summary
This is a phase III multi-centre study in two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease, Dialysis, Hyperphosphatemia, Dyslipidemia
CountriesHungary, Italy, Malaysia, North Macedonia, Poland, Russia, Serbia, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2007
Enrollment StartDec 2007
Primary CompletionNov 2009
TodayJul 2026
First PostedOct 11, 2007
Enrollment StartDec 1, 2007
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 18.7 years ago
Interventions
MCI-196drug
3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study
Placebodrug
3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study