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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)

1. juni 2026 opdateret af: Maimónides Biomedical Research Institute of Córdoba

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

236

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
      • Córdoba, Spanien, 14004
        • Hospital Universitario Reina Sofia

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

N/A

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Risk factors associated with a non-reactive or indeterminate QF-CMV
Tidsramme: Between 15 and 45 days after kidney transplantation
Absence of CMV-specific cellular immune response assessed by early QuantiFERON-CMV testing
Between 15 and 45 days after kidney transplantation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2019

Primær færdiggørelse (Faktiske)

30. april 2025

Studieafslutning (Faktiske)

30. april 2025

Datoer for studieregistrering

Først indsendt

25. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • FCO-PRE-2025-05

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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