Primary Outcome Measures:
- Incidence and severity of GI adverse events of Myfortic at 3 months [ Time Frame: 2, 6 and 12 weeks ] [ Designated as safety issue: Yes ]
- assessment of GI tolerability using a GI symptom rating scale 2 weeks, 6 weeks, and 3 months after initiation of the drug [ Time Frame: 2, 6 and 12 weeks ] [ Designated as safety issue: No ]
- incidence of biopsy-proven acute cellular rejection during the study period [ Time Frame: 2, 6 and 12 weeks ] [ Designated as safety issue: Yes ]
- incidence of graft loss or death during the study period [ Time Frame: 2, 6 and 12 weeks ] [ Designated as safety issue: Yes ]
- assessment of renal- and neurotoxic-sparing effects during the study period [ Time Frame: 2, 6 and 12 weeks ] [ Designated as safety issue: Yes ]
- assessment of neurotoxic-sparing effects during the study period [ Time Frame: 2, 6 and 12 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Incidence and severity of leukopenia during the study period [ Time Frame: 2, 6 and 12 weeks ] [ Designated as safety issue: Yes ]
- incidence of cytomegalovirus infection or disease during the study period [ Time Frame: 2, 6 and 12 weeks ] [ Designated as safety issue: Yes ]
Intervention Details:
Drug: Myfortic
Myfortic 360mg or 720 mg BID for 90 days
Drug: CellCept
CellCept 500mg or 1000mg BID for 90 days
This is a prospective, randomized, double-blinded, single center, safety and efficacy study comparing Myfortic with CellCept used after liver transplantation. Patients with biopsy-proven acute cellular rejection, renal insufficiency (i.e. acute or chronic renal failure requiring hemodialysis or patients with creatinine clearance < 50 ml/min), or calcineurin inhibitor-induced neurotoxicity (defined as the presence of neurologic symptoms such as tremors, altered mental status, seizures, etc) will be randomized to start on either Myfortic (720 mg po bid) or CellCept (1 gm po bid). In those patients with calcineurin-induced neurotoxicity or nephrotoxicity, tacrolimus or cyclosporine doses will also be reduced to maintain serum trough levels of 4-8 mg/dl or 100-200 mg/dl, respectively.
Comparison: Thirty patients will be enrolled and randomized in this two-armed, double-blinded study— half of the patients will receive Myfortic and the other half, CellCept.