Steroid-Avoidance Immunosuppression Regimen in Live-Donor Renal Allotransplant Recipients: A Prospective, Randomized, Controlled Study

Abstract

Objectives: Steroids have occupied a major role in renal transplantation for more than 4 decades. However, chronic use of steroids is associated with numerous comorbidities. We sought to elucidate the safety and efficacy of a steroid-free immuno­suppression regimen in live-donor renal transplant recipients.

Patients and Methods: One hundred patients were randomized to receive tacrolimus, mycophenolate mofetil, basiliximab induction, and steroids only for 3 days (experimental group, n=50 patients) or tacrolimus, mycophenolate mofetil, basiliximab induction, and steroid maintenance (control group, n=50 patients,). The median follow-up was 12 months.

Results: Patient and graft survival rates were 100% in both groups. The rate of biopsy-proven acute rejection was 16% in both groups. For patients in the control group, the mean serum creatinine level was 111.22 µmol /L compared with 110.39 µmol/L in patients in the experimental group. Post­transplant hypertension was encountered in 4% of the patients in the experimental group compared with 24% of the patients in the control group (P = .0009). Post­transplant diabetes mellitus was detected in 4% of the patients in the experimental group compared with 16% of the patients in the control group (P = .037). Posttransplant weight gain was reported in 6% of the patients in the experimental group compared with 15% of the patients in the control group (P = .001). The chronic allograft damage indexes of biopsy specimens at 1-year follow-up were comparable in both groups (2.48 vs 2.28, respectively) (P = .16).

Conclusions: In living-donor renal transplant recipients with low immunologic risk, steroid avoidance (using basiliximab induction, tacrolimus, mycophenolate mofetil maintenance, and 3 days’ steroid treatment) is feasible, safe, and carries with it fewer morbidities compared with the same immuno­suppressive protocol with steroid maintenance. Longer follow-ups are required to prove the safety of this regimen.