Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UNCCH-GCRC-1404 | |||
| ROCHE-CEL028 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of North Carolina | OTHER |
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mycophenolate mofetil | Drug |
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--
--Patient Characteristics--
Renal: Urine output at least 500 mL/day OR Creatinine less than 2.5 mg/dL
Other:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert E. Dupuis | University of North Carolina | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina School of Medicine | Chapel Hill | North Carolina | 27599-7070 | United States |
Not provided
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D005227 |
| Fatty Acids |
| D008055 | Lipids |