Long-term results of a randomized study comparing three immunosuppressive schedules with cyclosporine in cadaveric kidney transplantation

In this randomized controlled trial started in October 1990, 354 cadaveric kidney transplant recipients were assigned to receive either cyclosporine ( CsA) monotherapy (115 patients), CsA + steroids (117 patients), or CsA + st eroids + azathioprine (122 patients). The median follow-up was 85.1 mo. Thi rty-one deaths occurred (infection, 12; cardiovascular disease, 11; neoplas ia, 4; and others, 4), and 65 grafts were lost, mostly due to acute (15) or chronic rejection (50). The cumulative graft half-life was 18.1 yr. Accord ing to the "intention-to-treat," the 9-yr actuarial patient and graft survi val were 94.0% and 73.3%, respectively, in monotherapy. 87.3% and 65.9% in dual therapy, and 87% and 72.2% in triple therapy (P=0.647). At the last fo llow-up, the percentage of patients who remained with the original treatmen t was 51.2% in monotherapy, 81.7% in dual therapy, and 63.3% in triple ther apy. At the seventh year, the mean creatinine clearances were 54.9 +/- 17.6 ml/min in monotherapy, 57.9 +/- 23.4 in dual therapy, and 60.6 +/- 20.7 in triple therapy (P=0.375). Cataracts (P=0.000), osteoporosis (P=0.000). and cardiovascular complications (P=0.000) were more frequent in dual or tripl e therapy than in monotherapy. Actuarial graft survival at 9 yr in patients on monotherapy who had to have steroids added was similar to that of the o ther two groups (62.2% versus 69.3%, P=0.134). In conclusion, actuarial pat ient and graft survivals did not differ among the three schemes. The long-t erm renal function and survival were not affected in the patients on monoth erapy who needed the addition of steroids. Monotherapy was associated with a lower incidence of extrarenal complications than the other two regimens.