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.

Kidney Transplant Infection Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03123627
• Other study ID #: TIMOVAL
• Status: Completed
• Phase: Phase 3
• Start date: August 23, 2016
• Est. completion date: October 21, 2019

Study information

• Verified date: January 2021
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 21, 2019
• Est. primary completion date: October 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant Infection

Intervention

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.
• 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 ?> 0.2 interferon by CD8 + T cells stimulated by CMV-specific CMV antigens (QF reagent).

Locations

Country	Name	City	State
Spain	Hosìtal Universitario Reina Sofia	Córdoba

Sponsors (1)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CMV disease at 12 months after transplantation	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	12 months
Secondary	Percentage of patients who recover CMV-specific CD8+ T-cell immunity in the posttransplantation period after receiving thymoglobulin induction therapy and valganciclovir prophylaxis	CMV-specific CD8+ T-cell immunity will be defined using the QF-CMV technique as IFN-? 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)	12 months
Secondary	Incidence of CMV replication	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)	12 months