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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Incidence of CMV disease at 12 months after transplantation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
New profilaxis
Prophylaxis is discontinued when the patient developed CMV-specific cellular immunity.
Intervention: New profilaxis (Drug)
Profilaxis recommended by TTS
Valganciclovir prophylaxis until day +90 as recommended by the International Consensus document of the TTS.
Intervention: Profilaxis recommended (Drug)
Outcomes
Primary Outcomes
Incidence of CMV disease at 12 months after transplantation
Time Frame: 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 Outcomes
- Incidence of CMV replication(12 months)
- 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)