Planned Randomized Conversion From Tacrolimus to Sirolimus-Based Immunosuppressive Regimen in de Novo Kidney Transplant Recipients

• Main Author: Tedesco-Silva Junior, Hélio [UNIFESP]
• Publication Date: 2013
• Other Authors: Felipe, Claudia Rosso [UNIFESP], Garcia, V. D., Neto, E. D., Filho, M. A., Contieri, F. L. C., Carvalho, D. D. B. M. de, Pestana, Jose Osmar Medina [UNIFESP]
• Format: Article
• Language: eng
• Source: Repositório Institucional da UNIFESP
• Download full: http://repositorio.unifesp.br/handle/11600/37009; http://dx.doi.org/10.1111/ajt.12481
• topic: Conversion; kidney transplantation; sirolimus; tacrolimus

Planned conversion from tacrolimus to sirolimus was evaluated in de novo kidney transplant recipients. in this multicenter, randomized, open-label study, 297 patients were initially treated with tacrolimus, mycophenolate sodium and prednisone. of the 283 patients reaching 3 months, 97 were converted to sirolimus (SRL), 107 were maintained on tacrolimus (TAC) and 79 were patients receiving TAC without criteria to undergo intervention at month 3 (TACex). the primary objective was to show superior estimated glomerular filtration rate (eGFR) in the SRL group at month 24. of the 258 patients who completed 24 months, 91 (94%) were in the SRL group, 101 (94%) in the TAC group and 66 (84%) in the TACex group. in the intention-to-treat population there were no differences in eGFR (66.225.3 vs. 70.7 +/- 25.1, p=0.817) or in the severity of chronic sclerosing lesions scores in 24-month protocol biopsies. Higher mean urinary protein-to-creatinine ratio (0.36 +/- 0.69 vs. 0.15 +/- 0.53, p=0.03) and higher incidence of treated acute rejection between months 3-24 (13.4% vs. 4.7%, p=0.047) were observed in SRL compared to TAC group. in this population planned conversion from TAC to SRL 3 months after kidney transplantation was not associated with improved renal function at 24 months.