Head to Head Comparison of Myfortic vs. Cellcept in the Treatment of Kidney Transplant Recipients Using Our Current Center Standardized Concomitant Immunosuppressive Protocol
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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Observation of G.I. toxicity (nausea, vomiting, or diarrhea). One year patient and graft survival after initiation of study agent.Incidence of biopsy-proven acute rejection (vide infra). 4. Incidence of chronic allograft nephropathy (vide infra).
George W Burke, M.D.
University of Miami
United States: Institutional Review Board
|University Of Miami Miller School Of Medicine||Miami, Florida 33010|