Clinical trial NCT03123627: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplant Infection
Keywords: Cytomegalovirus, Seropositive
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Renal transplant CMV-Seropositive
* CD8+ Tcell CMV especific pretransplant (CMV-reactive quantiferon pretrasplant)
* \> 18 years (adult)
* Receiving Thymoglobulin induction therapy
* Receiving Valganciclovir prophylaxis
* Written informed consent for trial entry

Exclusion Criteria:

* Multivisceral transplants including kidney-pancreas.
* HIV-infected Patients
* Patients who can not comply with the monitoring protocol.

Primary outcomes:
measure: Incidence of CMV disease at 12 months after transplantation
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of patients who recover CMV-specific CD8+ T-cell immunity in the posttransplantation period after receiving thymoglobulin induction therapy and valganciclovir prophylaxis
timeFrame: 12 months
measure: Incidence of CMV replication
timeFrame: 12 months
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hosìtal Universitario Reina Sofia
Study officials:
References:
citation: Paez-Vega A, Gutierrez-Gutierrez B, Aguera ML, Facundo C, Redondo-Pachon D, Suner M, Lopez-Oliva MO, Yuste JR, Montejo M, Galeano-Alvarez C, Ruiz-San Millan JC, Los-Arcos I, Hernandez D, Fernandez-Ruiz M, Munoz P, Valle-Arroyo J, Cano A, Rodriguez-Benot A, Crespo M, Rodelo-Haad C, Lobo-Acosta MA, Garrido-Gracia JC, Vidal E, Guirado L, Cantisan S, Torre-Cisneros J; TIMOVAL Study Group. Immunoguided Discontinuation of Prophylaxis for Cytomegalovirus Disease in Kidney Transplant Recipients Treated With Antithymocyte Globulin: A Randomized Clinical Trial. Clin Infect Dis. 2022 Mar 9;74(5):757-765. doi: 10.1093/cid/ciab574.