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Hypothesis: Valganciclovir prophylaxis can be discontinued before 3 months in CMV-seropositive renal transplant recipients receiving induction thymoglobulin 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hosìtal Universitario Reina Sofia
Córdoba, Spain
Start Date
August 23, 2016
Primary Completion Date
October 21, 2019
Completion Date
October 21, 2019
Last Updated
February 2, 2021
150
ACTUAL participants
New profilaxis
DRUG
Profilaxis recommended
DRUG
Lead Sponsor
Maimónides Biomedical Research Institute of Córdoba
NCT04542733
NCT05224583
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