Planned randomized conversion from tacrolimus to sirolimus-based immunosuppressive regimen in de novo kidney transplant recipients

Silva H.T.; Felipe C.R.; Garcia V.D.; Neto E.D.; Filho M.A.; Contieri F.L.C.; De Carvalho D.D.B.M.; Pestana J.O.M.

Planned randomized conversion from tacrolimus to sirolimus-based immunosuppressive regimen in de novo kidney transplant recipients

Tipo

Artigo

Data de publicação

2013

Periódico

American Journal of Transplantation

Citações (Scopus)

40

Autores

Silva H.T.
Felipe C.R.
Garcia V.D.
Neto E.D.
Filho M.A.
Contieri F.L.C.
De Carvalho D.D.B.M.
Pestana J.O.M.

Resumo

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 (66.2 ± 25.3 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. In this multicenter, randomized, open-label study, the authors show that planned conversion from tacrolimus to sirolimus 3 months after kidney transplantation was not associated with improved renal function or histological structure at 24 months. © Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.