At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 245 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 3, Randomized, Double-Blind, Placebo-Controlled, Multi-center, Withdrawal Study Comparing MCI-196 v.s Placebo Following A 12-Week Dose Titration Period With MCI-196 in Stage V Subjects on Dialysis With Hyperphosphatemia
In Brief
A Phase 3 clinical trial evaluating MCI-196 and Placebo for Chronic Kidney Disease and 2 related conditions. Completed, enrolled 245 participants across 39 sites in 2 countries.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease, Dialysis, Hyperphosphatemia
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2007
Enrollment StartSep 2007
Primary CompletionSep 2009
TodayJul 2026
First PostedJul 25, 2007
Enrollment StartSep 1, 2007
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 18.9 years ago
Interventions
MCI-196drug
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose (Open-label) and 4 weeks of double blind
Placebodrug
3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind