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Sponsored by: |
Mitsubishi Tanabe Pharma Corporation |
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Information provided by: | Mitsubishi Tanabe Pharma Corporation |
ClinicalTrials.gov Identifier: | NCT00772382 |
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.
Condition | Intervention | Phase |
---|---|---|
Chronic Kidney Disease Dialysis Hyperphosphatemia |
Drug: MCI-196 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 100 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
MCI-196: Experimental |
Drug: MCI-196
3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Information at Mitsubishi Pharma America | MCI-196_A06@m-pharma.com |
United States, California | |
Los Angeles, California, United States | |
United States, Indiana | |
Evansville, Indiana, United States | |
United States, Louisiana | |
New Orleans, Louisiana, United States | |
United States, New York | |
Northport, New York, United States | |
United States, North Carolina | |
Durham, North Carolina, United States | |
United States, Vermont | |
Burlington, Vermont, United States | |
Canada, Ontario | |
Toronto, Ontario, Canada |
Principal Investigator: | Professor | Information at Mitsubishi Pharma America |
Responsible Party: | Mitsubishi Tanabe Pharma Corporation ( Study Project Manager ) |
Study ID Numbers: | MCI-196-A06 |
Study First Received: | October 10, 2008 |
Last Updated: | October 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00772382 |
Health Authority: | United States: Food and Drug Administration |
Chronic Kidney Disease Dialysis Hyperphosphatemia Phosphate binder |
Renal Insufficiency Metabolic Diseases Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Hyperphosphatemia Kidney Diseases Metabolic disorder Kidney Failure |
Phosphorus Metabolism Disorders |