Monitoring safety profile of the addiction of everolimus to the immunosuppression based in tacrolimus, mycophenolate mofetil and prednisone in HLA sensitized kidney transplant recipients

• Grant number: 20/07714-2
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Effective date (Start): September 01, 2020
• Effective date (End): August 31, 2021
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Principal Investigator: Elias David-Neto
• Grantee: Samara Silva do Carmo
• Host Institution: Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil
• Associated research grant: 17/19339-9 - A prospective, single center, randomized study comparing the efficacy and safety of the addition of everolimus to tacrolimus/mycophenolate mofetil/predinisone in kidney transplanted recipients HLA-sensitized, AP.TEM

Abstract

Kidney transplant (KTx) recipients with HLA sensitization have high risk of graft rejection. In order to improve the results of these KTx, a prospective and randomized study aimed to analyze a possible benefit of the addition of everolimus (EVR) to the immunosuppression based on tacrolimus (TAC), mycophenolate mofetil (MMF) and prednisone (PRED) is currently ongoing in the institution. However, the safety profile of this new immunosuppression association is unknown. This project aims to analyze the safety profile of the use of EVR in association with TAC, MMF, PRED in sensitized kidney transplant recipients.Safety profile assessment will be performed by monitoring the incidence of serious or not serious adverse events (AE), and also the changes in laboratory variables including blood and urinary biochemical and hematologic analysis in patients of the study (TAC/MMF/PRED/EVR, n=10) and control (TAC/MMF/PRED n=10) groups. These information will be obtained through elective medical visits and follow-up of the electronic records. The AE will have a specific term and subsequently will be grouped according to the organic system to which they belong, according to predetermined standardization. Such AE will also be classified according to their degree in mild, moderate, severe, very severe and associated with death. Continuous variables will be presented as means and compared by the ANOVA method, and categorical variables will be presented as medians and compared by the chi- square test.