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Title: Planned Randomized Conversion From Tacrolimus to Sirolimus-Based Immunosuppressive Regimen in de Novo Kidney Transplant Recipients
Authors: Tedesco-Silva Junior, Hélio [UNIFESP]
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]
Universidade Federal de São Paulo (UNIFESP)
Santa Casa de Misericordia
Universidade de São Paulo (USP)
Inst Urol & Nefrol
Hosp Univ Evangel Curitiba
Bonsucesso Gen Hosp
Keywords: Conversion
kidney transplantation
Issue Date: 1-Dec-2013
Publisher: Wiley-Blackwell
Citation: American Journal of Transplantation. Hoboken: Wiley-Blackwell, v. 13, n. 12, p. 3155-3163, 2013.
Abstract: 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.
ISSN: 1600-6135
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