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.

Phase 3

Completed

• Conditions: Kidney Transplant Infection
• Interventions: Drug: New profilaxis; Drug: Profilaxis recommended

• Registration Number: NCT03123627
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-23
• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-21
• Primary Completion: 2019-10-21
• Study Completion: 2019-10-21
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New profilaxis	New profilaxis	Prophylaxis is discontinued when the patient developed CMV-specific cellular immunity.
Profilaxis recommended by TTS	Profilaxis recommended	Valganciclovir prophylaxis until day +90 as recommended by the International Consensus document of the TTS.

Primary Outcome Measures

Name	Time	Method
Incidence of CMV disease at 12 months after transplantation	12 months	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 criteria for use in clinical trials

Secondary Outcome Measures

Name	Time	Method
Incidence of CMV replication	12 months	CMV replication was defined as \>1500 IU/mL in plasma or \>5000 IU/mL in whole blood. CMV replication was considered asymptomatic when it was not accompanied by CMV disease (CMV syndrome or CMV disease)
Percentage of patients who recover CMV-specific CD8+ T-cell immunity in the posttransplantation period after receiving thymoglobulin induction therapy and valganciclovir prophylaxis	12 months	CMV-specific CD8+ T-cell immunity will be defined using the QF-CMV technique as IFN-γ production equal to or greater than 0.2 IU/mL following stimulation of CD8+ T cells by CMV antigens (QF-CMV "Reactive").CMV replication was considered asymptomatic when it was not accompanied by CMV disease (CMV syndrome or CMV disease)

Trial Locations

Locations (1)

Hosìtal Universitario Reina Sofia; 🇪🇸 Córdoba, Spain