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.
Visão geral do estudo
Status
Descrição detalhada
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).
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Córdoba, Espanha, 14004
- Hospital Universitario Reina Sofia
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Risk factors associated with a non-reactive or indeterminate QF-CMV
Prazo: Between 15 and 45 days after kidney transplantation
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Absence of CMV-specific cellular immune response assessed by early QuantiFERON-CMV testing
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Between 15 and 45 days after kidney transplantation
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- FCO-PRE-2025-05
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