SAN FRANCISCO, May 07, 2007 /PRNewswire/ -- Interim results from a multicenter trial investigating a novel kidney-sparing treatment protocol using CellCept(R) (mycophenolate mofetil) were presented at the American Transplant Congress. This and other Spare the Nephron (STN) trials in kidney and liver transplant recipients examine ways to prevent rejection without damaging kidneys.
As transplant patients are living longer, doctors are finding that older therapies such as steroids and calcineurin inhibitors (CNIs) can cause impairment of kidney function and damage to the blood vessels and filtering capacity of the kidneys.(1)(2) The STN trials are being conducted at more than 35 transplant centers in the United States and Canada and use CellCept and other immunosuppressants in combinations that reduce or eliminate the use of steroids and CNIs.
"Our goal for the Spare the Nephron trial in kidney transplant recipients is to determine the safest and most effective immunosuppressive therapy regimen that avoids the nephrotoxic effects of CNIs while preventing rejection," said Matthew Weir, M.D., professor and director of the division of nephrology at the University of Maryland School of Medicine. "The preliminary study results are very encouraging."
Dr. Weir reported that first-year results in kidney transplant recipients demonstrated that patients on CellCept and sirolimus maintenance therapy showed improvements in glomerular filtration rate (GFR) of their kidneys without increasing rejection rates.
A total of 208 of 305 kidney transplant patients completed 12 months of follow-up in this open-label, prospective, randomized, multicenter study. Patients initially treated with CellCept and a CNI were randomized to receive CellCept and sirolimus or to continue their current treatment regimen of CellCept and a CNI. Efficacy endpoints included the proportions of patients experiencing acute reject ion, graft loss, death, and the percent change in measured GFR.
After 12 months of follow-up, investigators found acute rejection in 6.1% of patients in the CellCept and sirolimus group, compared to 7.3% of patients in the CellCept and CNI group. Graft loss was experienced by 2.0% of patients in the CellCept and sirolimus group, compared to 3.6% of patients in the CellCept and CNI group.
None of the patients in the CellCept and sirolimus group died, while one patient death was remotely related to the CellCept and CNI group. Patients in the CellCept and sirolimus group had a median 18.5% increase from baseline in GFR, compared to a median 4.4% decrease in the CellCept and CNI group. Safety outcomes were similar in both groups.
Optimizing use of immunosuppressants for achieving long-term success is the primary focus of these clinical trials. Kidney STN, liver STN and OptiCept are all studying CellCept with the goal of reducing CNI associated nephrotoxicity therapy to prolong graft and patient survival. Final results of this study, which will be available later this year, will provide more definitive conclusions about the long-term effect of these regimens on renal function.
CellCept is an immunosuppressant or anti-rejection drug approved for use in combination with other immunosuppressive drugs (cyclosporine and corticosteroids) for the prevention of rejection in patients receiving kidney, heart and liver transplants.
There are no adequate and well-controlled studies in pregnant women. As CellCept has been shown to have teratogenic effects in animals at subclinical doses on a body surface area basis, it may cause fetal harm when administered to a pregnant woman. CellCept should not be used in pregnant women unless the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within one week prior to beginning therapy even where there has been a history of infertility, unless due to hysterectomy.
Women of childbearing potential must use effective contraception before beginning CellCept therapy, during therapy and for six weeks following discontinuation of therapy. Two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method. If pregnancy occurs during treatment, the physician and patient should discuss the desirability of continuing the pregnancy (see complete product information).
Adverse events reported in >30% of renal, cardiac or liver transplant patients receiving CellCept (in combination with cyclosporine and corticosteroids) were pain, fever, headache, asthenia, anemia, leucopenia (patients should be monitored for neutropenia; dosing should be interrupted or the dose reduced if neutropenia develops), thrombocytopenia, leukocytosis, urinary tract infection, hypertension, hypotension, peripheral edema, hypercholesteremia, hypokalemia, hyperglycemia, creatinine, BUN and cough increased, hypomagnesemia, diarrhea, constipation, nausea, vomiting, respiratory infection, dyspnea, lung disorder, pleural effusion, tremor and insomnia.
Patients receiving immunosuppressant regimens are at increased risk of developing lymphomas and other malignancies, particularly of the skin.
Warning: Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of renal, cardiac or hepatic transplant patients should use CellCept. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years in the U.S., Roche has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2006, Roche was named one of the Top 20 Employers (Science magazine), ranked the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers, and in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or www.roche.us.
All trademarks used or mentioned in this release are protected by law. (1) Bennett WM. Insights into chronic cyclosporine nephrotoxicity. Int J Clin Pharmacol Ther 1996;34:515-9. (2) Bennett WM, DeMattos A, Meyer MM, Andoh T, Barry JM. Chronic cyclosporine nephropathy: the Achilles' heel of immunosuppressive therapy. Kidney Int 1996;50:1089-100.
CONTACT: Christopher Vancheri of Roche, +1-973-562-2203, or cell,+1-973-262-1175, , or Nichole Rothkopf ofKetchum, +1-646-935-3940, or cell, +1-646-942-0418,, for Roche Christopher.Vancheri@roche.com Nichole.Rothkopf@ketchum.com
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