The purpose of this study is to compare the pharmacokinetics of investigational 500 mg mycophenolate mofetil tablets with the approved 250 mg mycophenolate mofetil capsules during 10 days in the period immediately following renal transplantation. Patients with end stage renal disease have a high mortality rate on maintenance hemodialysis. Unfortunately, despite many advances, the mortality rate on dialysis for such patients remains high, making kidney transplantation increasingly the treatment of choice for most patients. The use of enhanced immunosuppression to treat established allograft rejection entails significantly increased risk for the patient in terms of opportunistic infection and the risk of immunosuppression-related malignancy. Inability to reverse rejection episodes leads to graft failure and the requirement for a return to dialysis therapy. Current dosing of mycophenolate mofetil requires patients to take up to 16 capsules per day and the availability of a 500 mg tablet would decrease this by 50%. This may increase patient compliance resulting in lower rejection rates.

Project Start
1997-02-20
Project End
1997-11-30
Budget Start
1996-10-01
Budget End
1997-09-30
Support Year
37
Fiscal Year
1997
Total Cost
Indirect Cost
Name
University of Michigan Ann Arbor
Department
Type
DUNS #
791277940
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109
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