CompletedNot Applicable

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

Spain236 participantsStarted 2019-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Between 15 and 45 days after kidney transplantation

Trial details

NCT IDNCT07621835

SponsorMaimónides Biomedical Research Institute of Córdoba

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More CMV Specific Immune Response trials