title: Long-term efficacy and safety of a calcineurin inhibitor-free regimen in live-donor renal transplant recipients.
abstract: Calcineurin inhibitor (CNI) nephrotoxicity is a major concern after renal transplantation. To investigate the safety and efficacy of a CNI-free immunosuppressive regimen, 132 live-donor renal transplant recipients were included in a prospective, randomized controlled trial. All patients received induction therapy with basiliximab and steroids. The patients were randomized to a maintenance immunosuppression regimen that included steroids, sirolimus, and either low-dose tacrolimus or mycophenolate mofetil (MMF). Over a mean follow-up period of approximately 5 yr, patient and graft survival did not significantly differ between the two maintenance regimens. Patient survival was 93.8% and 98.5% in the tacrolimus/sirolimus and MMF/sirolimus groups, respectively, and graft survival was 83% and 88%, respectively. However, the MMF/sirolimus group had significantly better renal function, calculated by Cockcroft-Gault, from the second year post-transplant until the last follow-up. In addition, this group was less likely to require a change in their primary immunosuppression regimen than the tacrolimus/sirolimus group (20.8% versus 53.8%, P = 0.001). The safety profile was similar between groups. In summary, after long-term follow-up, a CNI-free maintenance regimen consisting of sirolimus, MMF, and steroids was both safe and efficacious among low to moderate immunologic risk renal transplant recipients.
authors.affiliation: Urology and Nephrology Center, Mansoura University, Al-gomhoria Street, Mansoura, Egypt. afhamdy@yahoo.com
authors.forename: Ahmed F
authors.initials: AF
authors.lastname: Hamdy
authors.forename: Mohamed A
authors.initials: MA
authors.lastname: Bakr
authors.forename: Mohamed A
authors.initials: MA
authors.lastname: Ghoneim
mesh_terms: D048868:Adaptor Proteins, Signal Transducing; D019703:Calcineurin; D005500:Follow-Up Studies; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation; D019520:Living Donors; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011446:Prospective Studies; D020123:Sirolimus / Q000627:therapeutic use*; D016559:Tacrolimus / Q000627:therapeutic use*; D013997:Time Factors
chemical_list: D048868:Adaptor Proteins, Signal Transducing; C491861:CABIN1 protein, human; D007166:Immunosuppressive Agents; D019703:Calcineurin; D009173:Mycophenolic Acid; D020123:Sirolimus; D016559:Tacrolimus