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.

Maimónides Biomedical Research Institute of Córdoba

Status and phase: Completed; Phase 3

Conditions: Kidney Transplant Infection

Treatments: Drug: Profilaxis recommended; Drug: New profilaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT03123627

TIMOVAL

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

New profilaxis

Experimental group

Description:

Prophylaxis is discontinued when the patient developed CMV-specific cellular immunity.

Treatment:

Drug: New profilaxis

Profilaxis recommended by TTS

Active Comparator group

Description:

Valganciclovir prophylaxis until day +90 as recommended by the International Consensus document of the TTS.

Treatment:

Drug: Profilaxis recommended