Background Early conversion from calcineurin inhibitor to mammalian target of rapamycin inhibitor is one of the immunosuppressive strategies that have been investigated to mitigate long-term CNi associated adverse events. This study aims to evaluate the conversion from tacrolimus to sirolimus in de novo kidney transplant recipients. This multicenter, open-label study, planned to enroll 297 patients initially treated with tacrolimus, enteric-coated mycophenolate sodium (1440 mg/day, orally) and prednisone. The primary objective is to show superior glomerular filtration rate in the SRL group at 24 months after transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
Hospital University Evangélico de Curitiba, Curitiba, Parana, Brazil
Curitiba, Paraná, Brazil
Nephrology Service, Bonsucesso General Hospital. Rio de Janeiro, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
Kidney & Pancreas Transplant Unit, Santa Casa de Misericordia, Porto Alegre, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Urologia e Nefrologia & Medical School-FAMERP/HB-FUNFARME, São José do Rio Preto-SP, Brazil
São Jose Do Rio Preto, São Paulo, Brazil
Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
São Paulo, São Paulo, Brazil
Renal Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil.
São Paulo, São Paulo, Brazil
Renal Function calculated using the 4 variable MDRD formula
Time frame: 24 months
Survival free from first treated biopsy confirmed acute rejection episodes (tBCAR) > IA according to Banff 1997 classification.
Time frame: 24 months
Incidence of all treated acute rejections.
Time frame: 24 months
Incidence and severity of all tBCAR.
Time frame: 24 months
Patient and graft survival.
Time frame: 24 months
Incidence of treatment discontinuation
Time frame: 24 months
Incidence of adverse events.
Time frame: 24 months
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