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.

NCT03123627 | Completed Phase 3

• 1 other identifier: TIMOVAL
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant Infection

Keywords

Cytomegalovirus, Seropositive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Incidence of CMV replication

  12 months

Study Arms (2)

New profilaxis

EXPERIMENTAL

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

Drug: New profilaxis

Profilaxis recommended by TTS

ACTIVE COMPARATOR

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

Drug: Profilaxis recommended

Interventions

New profilaxis DRUG

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.

New profilaxis

Profilaxis recommended DRUG

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).

Profilaxis recommended by TTS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Multivisceral transplants including kidney-pancreas.
• HIV-infected Patients
• Patients who can not comply with the monitoring protocol.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

Hosìtal Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Related Publications (1)

• Paez-Vega A, Gutierrez-Gutierrez B, Aguera ML, Facundo C, Redondo-Pachon D, Suner M, Lopez-Oliva MO, Yuste JR, Montejo M, Galeano-Alvarez C, Ruiz-San Millan JC, Los-Arcos I, Hernandez D, Fernandez-Ruiz M, Munoz P, Valle-Arroyo J, Cano A, Rodriguez-Benot A, Crespo M, Rodelo-Haad C, Lobo-Acosta MA, Garrido-Gracia JC, Vidal E, Guirado L, Cantisan S, Torre-Cisneros J; TIMOVAL Study Group. Immunoguided Discontinuation of Prophylaxis for Cytomegalovirus Disease in Kidney Transplant Recipients Treated With Antithymocyte Globulin: A Randomized Clinical Trial. Clin Infect Dis. 2022 Mar 9;74(5):757-765. doi: 10.1093/cid/ciab574.

  PMID: 34228099 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 21, 2017
• Study Start: August 23, 2016
• Primary Completion: October 21, 2019
• Study Completion: October 21, 2019
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: beginning date: 07-01-2021, end date: 30-06-2022
• 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).

Locations

ES (1)