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.

PHASE3CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

August 23, 2016

Primary Completion Date

October 21, 2019

Study Completion Date

October 21, 2019

Conditions
Kidney Transplant Infection
Interventions
DRUG

New profilaxis

Primary endpoint: incidence of CMV disease at 12 months after transplantation. Study the predictive value of the assay of CD8 + T cell immunity specific for defined CMV-patients in which they can stop prophylaxis. The definition of CMV disease was based on those recommended by the American Society of Trasnplantation for use in clinical trials (Humar A. Am J Transplant 2006; 6:262-74) criteria.

DRUG

Profilaxis recommended

Secondary end points: percentage of patients developing T cell immunity in CMV-specific transplantation after receiving timoglubulina induction and valganciclovir prophylaxis. T cell development inmnunidad CD8 + CMV-specific is defined as production of γ\> 0.2 interferon by CD8 + T cells stimulated by CMV-specific CMV antigens (QF reagent).

Trial Locations (1)

14004

Hosìtal Universitario Reina Sofia, Córdoba

All Listed Sponsors
lead

Maimónides Biomedical Research Institute of Córdoba

OTHER