OBJECTIVES: I. Determine the effects of bile externalization and antibiotic gut
sterilization on the pharmacokinetics of mycophenolate mofetil in patients who have
undergone orthotopic liver transplantation.
II. Correlate serum concentrations of mycophenolic acid with inosine monophosphate
dehydrogenase activity in these patients.
Patients begin a mycophenolate mofetil (MMF)-containing regimen within the first 5 days
after transplantation. Patients have blood drawn on postoperative days 7, 21, 42, 70, 98,
126, and 154. Urine is collected on postoperative days 7, 21, and 42. Patients with T-tube
bile externalization also have bile collected on postoperative day 7.
PROTOCOL ENTRY CRITERIA:
Orthotopic liver or kidney transplant recipients who started on a mycophenolate
mofetil-containing immunosuppressive regimen within 5 days after transplant
Kidney transplant recipients will serve as study controls
- No concurrent bile acid sequestrants
- No mycophenolate mofetil as part of rescue therapy regimen
- No concurrent albumin replacement therapy
Renal: Urine output at least 500 mL/day OR Creatinine less than 2.5 mg/dL
- Not pregnant
- No mental incompetency
- No prisoners or parolees HIV negative
- No active infection defined as: Temperature above 101 F with WBC greater than
12,000/mm3 and left shift OR Two or more positive cultures of a single isolated
organism from blood, urine, or sputum