Clinical Trial

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

Study acronym: PREDICOR
Completed
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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.
Trial Details
NCT Number NCT07621835
Lead Sponsor Maimónides Biomedical Research Institute of Córdoba
Conditions CMV Specific Immune Response, Kidney Transplant, Kidney Transplant Recipient, CMV Reactivation
Enrollment 236 participants
Start Date 2019-01-01
Primary Completion 2025-04-30 (estimated)
Study Completion 2025-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-02