Clinical trial shows drug may offer a new option to prevent rejection of transplant...( can lead to the loss of the transplant...),Health

A total of 221 kidney transplant patients participated in the study. Of those, 148 received LEA29Y and 73 took cyclosporine as part of their maintenance treatment regimen. All patients also were treated with mycophenolate mofetil, corticosteroids and basiliximab -- standard immunosuppressive treatments used to help prevent rejection and maintain transplanted organ function.

The study compared the incidence of biopsy-proven acute kidney rejection at six months. The rates of acute rejection were similar in both patient groups: 19 percent of LEA29Y patients had acute rejection compared to 18 percent of patients receiving cyclosporine. The difference was not statistically significant.

Acute rejection episodes usually are reversible. In this study, only three percent of the LEA29Y patients and four percent of those receiving standard therapy lost their transplanted kidneys within six months of transplant.

At the American Transplant Congress, Vincenti will present the six-month safety and efficacy data. Additional data from the same study regarding kidney function, blood pressure and cholesterol level will be presented at the Congress by B. Nashan of the Klinik fur Viszeral und Transplantation Chirurgie in Germany.

The function of the transplanted kidney observed in patients who received LEA29Y was better than the function in those receiving cyclosporine. The glomerular filtration rate (GFR) -- a measure of the kidney's ability to filter waste -- was significantly better at six months in LEA29Y patients compared to cyclosporine patients. Patients treated with LEA29Y also had significantly lower levels of total cholesterol than patients treated with cyclosporine. In addition, trends toward lower blood pressure and less use of anti-hypertensive medication were observed in LEA29Y treated patients. The rates of discontinua
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Contact: Janet Basu
jbasu@pubaff.ucsf.edu
415-476-2557
University of California - San Francisco
17-May-2004