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European randomised trial of dual versus triple tacrolimus‐based regimens for control of acute rejection in renal allograft recipients

Abstract Two large multicentre studies have shown superiority of tacrolimus‐based immunosuppressive regimens compared with standard cyclosporine‐based therapy in renal transplantation. In these studies, tacrolimus was used in a triple drug regimen of tacrolimus, corticosteroids, and azathioprine. The present study aimed to determine whether a tacrolimus‐based dual regimen achieves a similar efficacy and safety profile compared with conventional triple therapy. In this prospective, open, multicentre trial, 249 patients were randomised to receive either dual therapy (n= 125) of oral tacrolimus (initial daily dose of 0.2 mg/kg) and oral prednisone or additionally, as a triple therapy (n= 124), oral azathioprine. The primary endpoint was the incidence of acute rejection at month 3. In addition, all patients were included into a follow‐up evaluation at 1 year after transplantation. Both treatment groups had similar baseline characteristics. At month 3, patient survival was 97.6% (dual) and 96.7% (triple); graft survival was 92.7% (dual) and 91.7% (triple). The incidence of treated acute rejection confirmed by biopsy was 27.4% (dual) and 24.8% (triple); difference 2.6%, 95% CI [‐9.4%‐12.9%], P= 0.755. The incidence of corticosteroid‐resistant rejection (biopsy‐confirmed) was 9.7% (dual) and 10.7% (triple). The overall adverse events profile was similar; leukopenia (1.6% vs 11.6%, P= 0.002) was more frequent with triple therapy. Between months 4 and 12, six (dual) and eight (triple) patients had a rejection. At month 12, patient survival was 95.6% (dual) and 93.6% (triple): graft survival was 91.8% (dual) and 90.7% (triple). Tacrolimus proved to be efficacious and safe with both dual and triple low‐dose regimens. The addition of azathioprine to a ta‐crolimus/corticosteroid‐based therapy did not result in an increased efficacy.