Azathioprine-cyclosporin A (CyA) double therapy versus CyA alone after the first rejection episode in kidney-transplanted patients under CyA. A randomized study.

A controlled trial was carried out in 78 kidney transplant recipients under cyclosporin A (CyA) monotherapy who had experienced a first rejection episode. Thirty-nine were randomly selected to receive azathioprine (AZA; 2 mg/kg per day) in combination with CyA (group AZA+), while the others continued to receive CyA alone (group AZA-). Four of the patients in the study died; three were in group AZA+ and the cause of their deaths was cardiovascular. Graft survival rates were 97% at 6, 12, and 24 months postrejection in group AZA+ as compared to 97%, 90%, and 81%, respectively, in group AZA- (P less than 0.05 at 12 and 24 months). Significantly more patients were free of rejection with the double therapy than with CyA monotherapy (75% vs 51% at 12 months; P less than 0.05). In spite of the addition of a second immunosuppressive drug, the CyA dosages given and the CyA trough blood levels maintained were similar in the two groups. Serum creatinine was similar in patients with and without AZA. Infectious complications were also similar in both groups. A significant macrocytosis was the only side effect of AZA therapy. On the whole, these data show the benefit of CyA-AZA double therapy in the prevention of rejection recurrence without exposing patients to either increased risk of infection or serious side effects of AZA. Whether this double therapy should be systematically administered to all recipients or only after a first rejection episode is discussed.

RCT Entities:   Population Interventions Outcomes