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.

January 29, 2021 updated by: Maimónides Biomedical Research Institute of Córdoba

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Córdoba, Spain, 14004
        • Hosìtal Universitario Reina Sofia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: New profilaxis
Prophylaxis is discontinued when the patient developed CMV-specific cellular immunity.
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.
Active Comparator: Profilaxis recommended by TTS
Valganciclovir prophylaxis until day +90 as recommended by the International Consensus document of the TTS.
Drug: 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 γ> 0.2 interferon by CD8 + T cells stimulated by CMV-specific CMV antigens (QF reagent).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients who recover CMV-specific CD8+ T-cell immunity in the posttransplantation period after receiving thymoglobulin induction therapy and valganciclovir prophylaxis
Time Frame: 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)
12 months
Incidence of CMV replication
Time Frame: 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)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2016

Primary Completion (Actual)

October 21, 2019

Study Completion (Actual)

October 21, 2019

Study Registration Dates

First Submitted

April 19, 2017

First Submitted That Met QC Criteria

April 19, 2017

First Posted (Actual)

April 21, 2017

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 29, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TIMOVAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Deidentified participant data.

Who can access the data: Data will be made available only to researchers whose proposed use of the data has been approved by the steering committee.

Types of analyses: Data will be available for a specified purpose to be communicated in writing to Dr Julián Torre-Cisneros or Dr Sara Cantisán.

Mechanisms of data availability: Data will be made available only with a signed data access agreement.

Any additional restrictions: The steering committee has the ultimate decision in approving or denying sample sharing.

IPD Sharing Time Frame

beginning date: 07-01-2021, end date: 30-06-2022

IPD Sharing Access Criteria

Data will be made available after the request is approved by the steering committee (J Torre-Cisneros, A Páez-Vega, S Cantisán).

Requests should be submitted in writing to Dr. Julián Torre-Cisneros (julian.torre.sspa@juntadeandalucia.es) or Dr Sara Cantisán (sacanti@hotmail.com).

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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