At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 116 enrolled
Drug / intervention
MCI-196drug
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-center, 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 for Chronic Kidney Disease and 2 related conditions. Completed, enrolled 116 participants across 21 sites in 2 countries.
Detailed Summary
The primary objective of this study is to demonstrate the long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia. The secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease, Dialysis, Hyperphosphatemia
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2008
Enrollment StartDec 2008
Primary CompletionAug 2010
TodayJul 2026
First PostedOct 15, 2008
Enrollment StartDec 1, 2008
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.7 years ago
Interventions
MCI-196drug
3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose