title: De novo everolimus for recipients of kidney transplants from HLA identical donors.
abstract: BACKGROUND
  Kidney transplant recipients from HLA-identical living donor have lower risk of acute rejection and greater graft survival compared to other types of kidney transplantation. Immunosuppressive regimens without calcineurin inhibitors (CNI) can further improve these results by reducing cardiovascular, metabolic and toxic events related to this drug class.
  
  
  OBJECTIVE
  This study aimed to evaluate efficacy and safety of a new immunosuppressive regimen with planned suspension of CNI.
  
  
  METHODS
  This was a prospective, single center and single treatment arm study to evaluate HLA-identical kidney transplant recipients receiving everolimus (EVR), tacrolimus (TAC) and corticosteroids, followed by TAC discontinuation 30 days after transplantation. TAC discontinuation was later postponed to the third month after an interim efficacy analysis.
  
  
  RESULTS
  Thirty-nine patients were included. Although mean TAC and EVR blood concentrations have remained within the proposed therapeutic ranges, five patients had biopsy-proven acute rejection and one patient had an episode of C4D-positive glomerulitis. This result led to the end of the inclusions. Interestingly, the proportion of patients with proteinuria greater than 0.5 g/L has not reached more than 22% of patients in any visit. Adverse events related to EVR use were the most incident in this population: oral ulcers, dyslipidemia and peripheral edema.
  
  
  CONCLUSIONS
  The proposed scheme was not effective for this population, particularly due to a high incidence of acute rejection. Safety profile showed that prolonged exposure to a high concentration of blood EVR increases the incidence of adverse events related to this drug.
authors.affiliation: Hospital do Rim, Fundação Osvaldo Ramos, Universidade Federal de São Paulo, Brazil.
authors.forename: Marina Pontello
authors.initials: MP
authors.lastname: Cristelli
authors.affiliation: Hospital do Rim, Fundação Osvaldo Ramos, Universidade Federal de São Paulo, Brazil.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Ferreira
authors.affiliation: Hospital do Rim, Fundação Osvaldo Ramos, Universidade Federal de São Paulo, Brazil.
authors.forename: Pedro
authors.initials: P
authors.lastname: Hannun
authors.affiliation: Hospital do Rim, Fundação Osvaldo Ramos, Universidade Federal de São Paulo, Brazil.
authors.forename: Claudia
authors.initials: C
authors.lastname: Felipe
authors.affiliation: Hospital do Rim, Fundação Osvaldo Ramos, Universidade Federal de São Paulo, Brazil.
authors.forename: Wilson
authors.initials: W
authors.lastname: Aguiar
authors.affiliation: Hospital do Rim, Fundação Osvaldo Ramos, Universidade Federal de São Paulo, Brazil.
authors.forename: Marcello
authors.initials: M
authors.lastname: Franco
authors.affiliation: Hospital do Rim, Fundação Osvaldo Ramos, Universidade Federal de São Paulo, Brazil.
authors.forename: Hélio
authors.initials: H
authors.lastname: Tedesco-Silva
authors.affiliation: Hospital do Rim, Fundação Osvaldo Ramos, Universidade Federal de São Paulo, Brazil.
authors.forename: José
authors.initials: J
authors.lastname: Medina-Pestana
mesh_terms: D000328:Adult; D000068338:Everolimus / Q000627:therapeutic use*; D005260:Female; D006650:Histocompatibility Testing; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation; D019520:Living Donors; D008297:Male; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus