To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.
Evaluate the safety and efficacy of Myfortic in combination with tacrolimus and anti-thymocyte globulin in an early corticosteroid withdrawal protocol. Secondary objective is to determine the pharmacokinetic-pharmacodynamic profile of Myfortic in a corticosteroid withdrawal protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
* Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter * Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).
The Christ Hospital
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Incidence of All Biopsy Proven Acute Rejection.
Treatment efficacy, defined as the incidence of all biopsy proven acute rejection. Biopsy was proven with tissue samples collected on patients with elevated serum creatinine
Time frame: 12 months
Patient and Allograft Survival 12 Months
Patient and allograft survival at 12 months post-transplant. Allograft survival is different from rejection. An allograft can have rejection, but the allograft can still have survival. If an allograft fails and is no longer functioning this would be considered allograft failure and non-survival.
Time frame: 12 months
Renal Function at 12 Months
Renal function measured by serum creatinine (SCr) at 12 months post-transplant
Time frame: 12 months
Incidence of Post Transplant Infections
Incidence of post transplant infections that resulted in hospitalization
Time frame: 12 months
GI Toxicities
Hospitalizations due to Gastrointestinal (GI) toxicities of mycophenolic acid enteric coated (Myfortic)
Time frame: 12 months
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