Graft Versus Host Disease
Conditions
Keywords
disease-related problem/condition, graft versus host disease, rare disease
Brief summary
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.
Detailed description
PROTOCOL OUTLINE: 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.
Interventions
DRUGmycophenolate mofetil
Sponsors
University of North Carolina
National Center for Research Resources (NCRR)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- 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 --Prior/Concurrent Therapy-- * No concurrent bile acid sequestrants * No mycophenolate mofetil as part of rescue therapy regimen * No concurrent albumin replacement therapy --Patient Characteristics-- Renal: Urine output at least 500 mL/day OR Creatinine less than 2.5 mg/dL Other: * 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
Countries
United States
Outcome results
None listed