Cyclosporine therapy has long been the mainstay of immunosuppressive treatment in renal transplantation despite its known toxic effect on kidney function, which can cause kidney failure and transplant loss. CellCept, a newer immunosuppressant drug, is non-kidney toxic and the study set out to discover whether the use of CellCept could effectively replace cyclosporine and result in an improved function of the damaged kidney.
Kidney function can be assessed by the rate at which it removes creatinine, a waste product generated from muscle metabolism. In kidney transplant patients treated long-term, on going kidney damage is characterized by progressively increasing serum creatinine levels ("creeping creatinine"). The results of this study presented today show that 58% of patients on CellCept therapy without cyclosporine had a reversal or stabilisation of their kidney function compared to 32% of patients who continued on cyclosporine, as measured by decreasing serum creatinine levels.
CellCept has been shown to have a non-kidney toxicity profile 1 compared to other immunosuppressants and this allows for improved kidney function whilst minimising the risk of organ rejection.
"The results are very encouraging," said key investigator Dr Christopher Dudley, Southmead Hospital, Bristol, England. "We have suspected that continued use of calcineurin inhibitor (CNI) immunosuppressant therapies (such as cyclosporine), in chronically damaged kidneys may contribute to progressive kidney failure."
Dr Dudley continued, "By offering safe strategies to reduce the use of drugs toxic to the kidney the long term survival of the transplanted organ can be improved. These data suggest that CellCept is one such strategy to help patients to retain their transplanted kidneys longer. These are important findings."
Study Details
These results come from an on-going study being conducted amongst 143 patients who have received a kidney transplant but are showing signs of deteriorating kidney function. All the patients were on an immunosuppressant regimen, which included cyclosporine. Following entry in the study patients were randomized to treatment with CellCept and cyclosporine withdrawal (n=73), or to continue treatment with cyclosporine (n=70) over a 34-week period.
Roche in Transplantation
Roche is strongly committed to improving the long-term outcomes of transplantation and enhancing the quality of life of transplant recipients. Roche has developed three innovative therapies that improve graft and post-transplant health: CellCept is the cornerstone of low toxicity immunosuppressant therapies. CellCept is the largest selling branded immunosuppressive in North America, offers both physicians and patients the possibility of an effective long term immunosuppressive regimen with low toxicity, Zenapax prevents the acute rejection of the newly transplanted organ, and Cymevene/Cytovene/Valcyte has been developed for the prevention and treatment of cytomegalovirus, a dangerous viral infection associated with transplantation. Recently, Roche have announced a co-development agreement with Isotechnika for their new medicine, ISATx 247, a potentially more potent and less toxic calcineurin inhibitor. In addition, Roche supports basic research in transplantation with its funding of the independent Roche Organ Transplantation Research Fund (ROTRF), which directly supports innovative research projects attracting new researchers with innovative and novel scientific ideas to meet unmet medical needs in solid organ transplantation.
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche's innovative products and services address needs for the prevention, diagnosis and treatment of disease, thus enhancing people's well being and quality of life.
1. Danowitch G. Transplantation Reviews (2000) 14: 65-81.
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