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 (PREDICOR)

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplant; Kidney Transplant Recipient; CMV Specific Immune Response; CMV Reactivation

Detailed Description

Study Hypothesis: In the absence of available techniques to assess CMV-specific cellular immunity, it may be possible to predict which patients will fail to develop a CMV-specific cellular immune response before day 45 post-transplant.

Objective:

Primary objective:

• Derivation Cohort: To evaluate the risk factors associated with a non-reactive or indeterminate QF-CMV result before day 45 post-transplant in CMV-seropositive (R⁺) recipients who did not receive ATG prophylaxis.
• Validation Cohort: To validate these risk factors in an independent validation cohort.

Secondary Objectives:

• To confirm whether patients with a non-reactive or indeterminate QF-CMV result before day 45 post-transplant and without ATG induction develop a higher rate of clinically significant CMV infection compared with those with a reactive QF-CMV result during the first 6 months post-transplant.
• To confirm whether these same patients present a higher rate of viral replication during the first 6 months post-transplant.

Study Population: The study will include adult patients (>18 years) who are CMV-seropositive (R⁺), received a kidney transplant during the study period, did not receive ATG prophylaxis, and underwent QF-CMV testing on day 45 post-transplant (with a window period between day 30 and day 60 post-transplant).

• Study Type: Observational
• Enrollment (Actual): 236

Contacts and Locations

Study Locations

• Spain
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofía

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Maimónides Biomedical Research Institute of Córdoba

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: May 25, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Kidney Transplantation; CMV; Solid Organ Transplantation; QuantiFERON-CMV
• Other Study ID Numbers: FCO-PRE-2025-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No