Steroid or tacrolimus withdrawal in renal transplant recipients using sirolimus

• DOI: 10.1007/s11255-011-0001-3
• Publication Date: 2011-07-14T04:34:03Z
• Authors: Tainá Veras de Sa...; Kelly Miyuki Harada; Cláudia Rosso Felipe; Nelson Zocoler Ga...; Edison Luiz Mandi...; Edson Ikehara; Fernando Alfieri; Hélio Tedesco-Sil...; José Osmar Medina...
• Keywords: Adult; Graft Rejection; Immunosuppression Therapy; Male; Sirolimus; Adolescent; Biopsy; Calcineurin Inhibitors; Graft Survival; Anti-Inflammatory Agents; Kaplan-Meier Estimate; Middle Aged; Kidney Transplantation; Methylprednisolone; 3. Good health; 03 medical and health sciences; 0302 clinical medicine; Humans; Prednisone; Drug Therapy, Combination; Female; Immunosuppressive Agents; Aged

Calcineurin inhibitor (CNI) and steroid (ST) withdrawal are strategies under investigation to reduce long-term toxicities associated with current immunosuppressive regimens. We conducted a single center, prospective trial comparing the efficacy and safety of CNI or ST withdrawal in kidney transplant recipients receiving sirolimus-based immunosuppressive regimen.Forty-seven recipients of first renal transplant with non-HLA-identical living donors received sirolimus (SRL), tacrolimus (TAC), and ST without induction therapy and were randomized to undergo ST (TAC/SRL group, n = 24) or TAC (SRL/ST group, n = 21) withdrawal 3 months after transplantation. Primary efficacy and safety endpoints were the incidence of biopsy-confirmed acute rejection (BCAR) and renal function at 12 months.No differences were observed in the incidence of BCAR (4.2% vs. 9.5%), graft (95.8% vs. 95.6%), and patient (95.8% vs. 95.6%) survivals or in renal function (60 ± 11.5 vs. 63.4 ± 10.5 ml/min, P = 0.361). Higher mean cholesterol concentration was observed in the SRL/ST group (191.9 ± 63.3 vs. 241.6 ± 61.5 mg/dl, P = 0.019). Treatment discontinuation due to adverse events occurred in 12.5% of patients in TAC/SRL group and 21.7% in SRL/ST group.Within this short period of observation, our study was unable to detect any significant difference in major transplant outcomes comparing CNI and ST elimination strategies.