Early steroid withdrawal in renal transplantation with tacrolimus dual therapy: A pilot study

Background. With tacrolimus-based immunosuppression, it appears safe to withdraw steroids 3 to 6 months after renal transplantation. We hypothesized whether steroids could also be safely withdrawn early after transplantation. Methods. Sixty-two patients (first or second transplant, with no previous immunological failure, and current panel reactive human leucocyte antigen [HLA] antibodies [PRA]<50%), treated with tacrolimus, were prospectively randomized to stop steroids (10 mg prednisolone) after day 7 posttransplantation (stop group [STOP], n=28) or to gradually wean off steroids in 3 to 6 months (tapering group [TAP], n=34). Analyses were performed on an intention-to-treat basis. Results. After a median follow-up of 2.7 years, patient and graft survival were 97 and 90% and comparable between both groups (P=0.11 and P=0.13, respectively). The incidence of acute rejection was 29 (STOP) versus 33% (TAP) (P=0.30). The time to the first rejection was a median of 35 days (STOP) versus 11 days (TAP) (P=0.19). The severity of the rejections (1997 Banff classification) was comparable (P=0.57). Creatinine clearance and proteinuria were similar (P>0.70). The incidence of infections was comparable (P>0.10). The incidence of new-onset diabetes mellitus, defined as the use of antidiabetic medication, was 8.0 (STOP) versus 30.3% (TAP) (P=0.04). All cases occurred in the STOP group after 1 year, while all cases occurred in TAP in the first 4 months (P<0.001). Conclusions. Compared with tapering in 3 to 6 months, stopping steroids I week posttransplantation results in comparable patient and graft survival and in a similar incidence of acute rejections. The incidence of new-onset diabetes may be reduced. The immunosuppressive benefit of adding 10 mg prednisolone to tacrolimus seems to be limited.