Immunosuppression Clinical Trial
Official title:
A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic in Liver Transplant Recipients
The objective of this study is to compare the safety and efficacy of Myfortic with CellCept in liver transplant patients. Myfortic and CellCept are both immunosuppressive (anti-rejection) drugs. CellCept is commonly used after liver transplantation but gastrointestinal (GI) side effects are very common, sometimes necessitating in its discontinuation. Myfortic is a new drug similar to CellCept, except it is enteric-coated. Our hypothesis is that Myfortic has less GI side effects than CellCept and also has comparable effectiveness to CellCept.
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.
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