At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 632 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, Multicentre, Open Label, Flexible Dose, Long Term Safety Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
In Brief
A Phase 3 clinical trial evaluating MCI-196 and Another Phosphate binder (Sevelamer) for Chronic Kidney Disease and 2 related conditions. Completed, enrolled 632 participants across 115 sites in 15 countries.
Detailed Summary
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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease, Dialysis, Hyperphosphatemia
CountriesAustria, Czechia, France, Germany, Hungary, Italy, Malaysia, North Macedonia, Poland, Russia, Serbia, South Africa, Spain, Ukraine, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2007
Enrollment StartNov 2007
Primary CompletionAug 2010
TodayJul 2026
First PostedOct 12, 2007
Enrollment StartNov 1, 2007
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.7 years ago
Interventions
MCI-196drug
3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose
Another Phosphate binder (Sevelamer)drug
Current approved dosing recommendations for 12 weeks