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RANDOMIZED CLINICAL TRIAL, OPEN, MULTICENTER PARALLEL, NO SUSPENSION Inferiority Prophylactic Treatment With Valganciclovir IN KIDNEY TRANSPLANT CMV-seropositive CELLULAR IMMUNITY TO DEVELOP CD8 + CMV-SPECIFIC TREATMENT AFTER INDUCTION Thymoglobulin.

2017-04-24 07:46:58 | BioPortfolio

Summary

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.

Study Design

Conditions

Efficacy/Safety of Valganciclovir Prophylaxis Suspend in CMV-seropositive Kidney Transplant Recipients With CD8 + Cellular Immunity CMV-specific Transplant

Intervention

New profilaxis, Profilaxis recommended

Location

Hosìtal Universitario Reina Sofia
Córdoba
Spain
14004

Status

Recruiting

Source

Maimónides Biomedical Research Institute of Córdoba

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-04-24T07:46:58-0400

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