A randomized clinical trial of cyclosporine in cadaveric renal transplantation.

In a randomized multicenter trial, 209 recipients of cadaveric renal transplants were treated either with cyclosporine and prednisone or with standard therapy that included azathioprine and prednisone. Predicted graft survival at one year was 80.4 per cent in patients receiving cyclosporine and 64.0 per cent in those receiving standard therapy (P = 0.003). Predicted patient survival at one year was 96.6 per cent in patients given cyclosporine and 86.4 per cent in those given standard therapy. A detrimental effect on predicted graft survival at one year was seen in patients treated with cyclosporine if they received kidneys that were perfused by machine for longer than 24 hours (70 vs. 88 per cent, P = 0.005) or if the time used to perform the surgical anastomosis was longer than 45 minutes (60 vs. 89 per cent, P = 0.002). In the group receiving standard therapy, predicted graft survival was better in patients who had had five or more blood transfusions than in those who had had two to four transfusions (77 vs. 55 per cent, P = 0.05). Serum creatinine was 2.6 mg per deciliter in patients receiving cyclosporine 90 days after transplantation and 2.0 mg per deciliter in those receiving standard therapy (P = 0.03). Lymphoma developed in one patient receiving cyclosporine. We conclude that cyclosporine is preferable to azathioprine in preventing renal transplant rejection. Further studies will be required to determine the optimal regimen with this agent.