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Hypothesis:Valganciclovir prophylaxis can be discontinued before 3 months in CMV-seropositive renal transplant recipients receiving induction timogloblina when developing CMV-specific cellular immunity after transplantation.
Objective Meet the efficacy and safety of valganciclovir prophylaxis suspend in CMV-seropositive kidney transplant recipients with CD8 + cellular immunity CMV-specific transplant, receiving Thymoglobulin induction and maintain cellular immunity-specific CD8 + CMV after transplantation.
Design: noninferiority clinical trial (study A) in CMV-seropositive kidney transplant recipients with CMV-specific cellular immunity pretransplant (Quantiferon reactive CMV) received induction with thymoglobulin
Patients meeting inclusion criteria will be randomized to:
- Control Arm: valganciclovir prophylaxis until day +90 as recommended by the International Consensus document of the TTS (Transplantation 2013:96:333-360).
- Experimental arm: prophylaxis with valganciclovir and determination of CMV-specific cellular immunity day +15, +30, +45 and +60. Prophylaxis was discontinued when the patient developed CMV-specific cellular immunity. Patients who did not develop CMV specific immunity continue prophylaxis until day +90.
Analysis: The incidence of CMV disease according to the strategy used was calculated using Kaplan-Meier curves that were compared using the log-rank test.
Efficacy/Safety of Valganciclovir Prophylaxis Suspend in CMV-seropositive Kidney Transplant Recipients With CD8 + Cellular Immunity CMV-specific Transplant
New profilaxis, Profilaxis recommended
Hosìtal Universitario Reina Sofia
Maimónides Biomedical Research Institute of Córdoba
Published on BioPortfolio: 2017-04-24T07:46:58-0400
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