A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
Tracking Information
Start Date ICMJE | November 2007 |
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Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: December 26, 2007) | The long-term safety and tolerability profile of MCI-196 in subjects with CKD on dialysis with hyperphosphatemia [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE (submitted: October 10, 2007) | The long-term safety and tolerability profile of MCI-196 in subjects with CKD on dialysis with hyperphosphatemia [ Time Frame: 52 weeks ] |
Change History | Complete list of historical versions of study NCT00542815 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: December 26, 2007) | The long-term efficacy and safety, with regard to both hyperphosphatemia and dyslipidemia, of MCI-196. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ] |
Original Secondary Outcome Measures ICMJE (submitted: October 10, 2007) | The long-term efficacy and safety, with regard to both hyperphosphatemia and dyslipidemia, of MCI-196. [ Time Frame: 52 weeks ] |
Descriptive Information
Brief Title ICMJE | A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia |
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Official Title ICMJE | 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 |
Brief Summary | This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07, E08 and E09 studies will allow exposure to MCI-196 for up to 52 weeks |
Detailed Description | Following completion of one of the Phase III studies (E07, E08 or E09) eligible patients will receive either MCI-196 for up to 52 weeks. The study is in two periods. The initial period allows flexible dosing for a period of 8 weeks. This will allow subjects to achieve individually optimised doses. After 8 weeks, subjects will continue flexible dosing with MCI-196 but with titration intervals every 4 weeks instead of every 2 weeks. Subjects previously exposed to MCI-196 will end the study at Week 40. |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Recruitment Status ICMJE | Recruiting | ||||
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Estimated Enrollment ICMJE | 800 | ||||
Estimated Completion Date | August 2010 | ||||
Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
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Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Austria, Czech Republic, France, Germany, Hungary, Italy, Macedonia, The Former Yugoslav Republic of, Malaysia, Poland, Russian Federation, Serbia, South Africa, Spain, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00542815 | ||||
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Responsible Party | Study Project Manager, Mitsubishi Tanabe Pharma Corporation | ||||
Study ID Numbers ICMJE | MCI-196-E10 | ||||
Study Sponsor ICMJE | Mitsubishi Tanabe Pharma Corporation | ||||
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Investigators ICMJE |
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Information Provided By | Mitsubishi Tanabe Pharma Corporation |
Source: http://clinicaltrials.gov/