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Sponsors and Collaborators: |
University of Miami Novartis |
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Information provided by: | University of Miami |
ClinicalTrials.gov Identifier: | NCT00533624 |
The comparison the incidence of G.I. toxicity between Myfortic® vs. Cellcept® in 150 sequential patients, in which 75 will be randomized to Cellcept® and 75 to Myfortic® in first and second living or deceased donor renal transplant recipients.
Condition | Intervention | Phase |
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End Stage Renal Disease |
Drug: Mycophenolate Sodium Delayed Release Tablets Drug: Mycophenolate Mofetil |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Head to Head Comparison of Myfortic vs. Cellcept in the Treatment of Kidney Transplant Recipients Using Our Current Center Standardized Concomitant Immunosuppressive Protocol |
Enrollment: | 150 |
Study Start Date: | December 2004 |
Study Completion Date: | February 2006 |
Arms | Assigned Interventions |
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1: Myfortic: Active Comparator
Myfortic Group: Myfortic® 1,440 mg/day in two divided doses (induced with either the IL-2 receptor inhibitors or thymoglobulin). Tacrolimus will be dosed to 12-hour trough levels of 8-10 ng/ml. Methylprednisolone is to be given as per our center protocols, weaning to dose levels of <0.1 mg/kg by 3-6 months post-operatively.
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Drug: Mycophenolate Sodium Delayed Release Tablets
Myfortic® 1,440 mg/day
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2. Cellcept: Active Comparator
Cellcept® 2,000 mg/day, in divided doses (induced with either the IL-2 receptor inhibitors or thymoglobulin). Tacrolimus will be dosed to 12-hour trough levels of 8-10 ng/ml. Methylprednisolone is to be given as per our center protocols, weaning to dose levels of <0.1 mg/kg by 3-6 months post-operatively. |
Drug: Mycophenolate Mofetil
Cellcept® 2,000 mg/day
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Purpose and Description:
The purpose of the study is to determine if gastrointestinal toxicity of an anti-rejection medication Myfortic® (mycophenolic acid delayed release) is less than equivalent doses of a similar anti-rejection medication Cellcept® (mycophenolate mofetil, MMF) in patients receiving their first or second kidney transplant from cadaver or living donors.
This study consist of two randomized groups, 75 patients given 3 doses of Thymoglobullin (Group I) vs. 75 patients given 3 doses of Thymoglobulin and 2 doses of Basiliximab (Group II).
Our standard maintenance protocol dosing of tacrolimus, IMPDH inhibitor (vide infra) and one week course of corticosteroids.
Patients will be randomized to receive Myfortic® 1,440 mg/day vs. Cellcept® 2,000 mg/day, each in two divided doses (induced with either the IL-2 receptor inhibitors or thymoglobulin). Tacrolimus will be dosed to 12-hour trough levels of 8-10 ng/ml. Methylprednisolone is to be given as per our center protocols, weaning to dose levels of <0.1 mg/kg by 3-6 months post-operatively.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
University of Miami Miller School of Medicine | |
Miami, Florida, United States, 33136 |
Principal Investigator: | George W Burke, M.D. | University of Miami |
Study ID Numbers: | CERL080A-US10 |
Study First Received: | September 19, 2007 |
Last Updated: | September 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00533624 History of Changes |
Health Authority: | United States: Institutional Review Board |
Gastrointestinal toxicity |
Renal Insufficiency Immunologic Factors Urologic Diseases Renal Insufficiency, Chronic Mycophenolate mofetil |
Mycophenolic Acid Kidney Failure, Chronic Kidney Diseases Immunosuppressive Agents Kidney Failure |
Renal Insufficiency Immunologic Factors Urologic Diseases Renal Insufficiency, Chronic Physiological Effects of Drugs Mycophenolate mofetil |
Kidney Failure, Chronic Kidney Diseases Immunosuppressive Agents Pharmacologic Actions Kidney Failure |