Risk Factors Associated With the Absence of CMV-specific Cellular Immune Response in the Early Post-transplant Period in Low-risk CMV-seropositive Kidney Transplant Recipients

NCT07621835 | Completed

• 1 other identifier: FCO-PRE-2025-05
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to identify risk factors associated with the absence of CMV-specific cellular immune response in low-risk CMV-seropositive kidney transplant recipients in the early post-transplant period. The participant population includes adult CMV-seropositive kidney transplant recipients who did not receive antithymocyte globulin (ATG) induction therapy and underwent QuantiFERON-CMV testing within the first 45 days after transplantation. The main question it aims to answer is: \- Is it possible to predict which patients will fail to develop a CMV-specific cellular immune response before day 45 post-transplant in the absence of directly available immune assessment techniques? Researchers will compare patients with reactive QuantiFERON-CMV results to patients with non-reactive or indeterminate results to identify factors associated with the absence of CMV-specific cellular immune response. Participants will have retrospective clinical and laboratory data collected from medical records.

Conditions

CMV Specific Immune Response; Kidney Transplant; Kidney Transplant Recipient; CMV Reactivation

Keywords

CMV; Kidney Transplantation; QuantiFERON-CMV; Solid Organ Transplantation

Outcome Measures

Primary Outcomes (1)

• Risk factors associated with a non-reactive or indeterminate QF-CMV

  Absence of CMV-specific cellular immune response assessed by early QuantiFERON-CMV testing

  Between 15 and 45 days after kidney transplantation

Study Arms (2)

Derivation cohort

The first phase will identify clinical and immunological risk factors associated with a non-reactive or indeterminate QF-CMV test result performed before day 45 post-transplant.

Validation cohort

In the second phase, the risk factors identified in the derivation cohort will be tested in an independent cohort to validate their predictive value for the early absence of CMV-specific cellular immunity.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will conduct a retrospective, observational, multicenter cohort study of CMV-seropositive (R⁺) kidney transplant recipients who did not receive ATG induction, between 1 January, 2019 and 30 April, 2025.

You may qualify if:

• Age \>18 years
• Kidney or pancreas-kidney transplant recipients with positive CMV serology
• QF-CMV test performed on day 45 post-transplant (window period between day 30 and day 60 post-transplant)
• CMV PCR testing performed at least every two weeks during the first three months post-transplant

You may not qualify if:

• HIV-infected patients
• Multivisceral transplant recipients
• Patients scheduled to receive universal prophylaxis despite having a reactive QF-CMV result
• Patients who received ATG induction therapy
• Less than 6 months of post-transplant follow-up

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

HOSPITAL Universitario REINA SOFIA

Córdoba, 14004, Spain

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 2, 2026
• Study Start: January 1, 2019
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

ES (1)