Mycophenolic acid Observational Renal Transplant Program: A phase IV, non-interventional, multi-center, open-label, prospective, observational study of the safety, effectiveness, tolerability and compliance of immunosuppressive regimens using mycophenolic acid to treat de novo renal transplant patients in routine clinical practice.
The purpose of this study is to compare the short and long term tolerability, safety, effectiveness, and patient compliance of current and newly emerging immunosuppressive regimens used in the management of de novo renal transplant patients in routine clinical practice. The regimens will include MPA (mycophenolic acid) therapies myfortic® (mycophenolate sodium, also known as EC-MPS) and CellCept® (MMF). Approximately 600 de novo (newly transplanted within 2 weeks) renal transplant patients from approximately 30-60 US centers will be enrolled in the study. Observational data will be collected prospectively from baseline for a period of approximately three years at specified intervals that generally follow routine clinic visits post-transplantation.
Primary Investigator: Jon Yamaguchi MD
Sub-Investigator: Antonio Di Carlo MD

A multicenter, randomized, double blind, double dummy controlled study to assess the tolerability of an increased dose of myfortic® after conversion from CellCept® in renal transplant recipients who required CellCept® dose reductions due to gastrointestinal symptoms.
The study will examine if conversion to myfortic® from CellCept® allows an escalated dose of mycophenolic acid (MPA) to be tolerated and maintained in post-renal transplant patients with demonstrated susceptibility to the GI side effect of CellCept. The primary objective of this study is to assess whether conversion to myfortic® permits a dose increase to be tolerated and maintained for 4 weeks in renal transplant patients whose CellCept® dose had been decreased due to GI symptoms. Tolerability will be defined as the overall assessment of improved or no change in the intensity of physician-assessed GI symptoms at end of study. The population will consist of approximately 232 randomized patients aged 18 to 75 who have undergone renal transplantation and are currently on an immunosuppressive regimen that includes CellCept®. These patients will be recruited from the US, Canada, Argentina, Brazil, Germany, Italy, and France, in approximately 40 centers.
Primary Investigator: Antonio Di Carlo MD
Sub-Investigator: Jon Yamaguchi MD

Questions?
Please contact:

Aimee N. Ahari
Clinical Research Coordinator
UVM College of Medicine
Department of Surgery
Telephone: 802-847-3826