CMV Specific Immune ResponsePREDICORNCT07621835
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
An observational study of CMV Specific Immune Response and Kidney Transplant, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CMV Specific Immune Response, Kidney Transplant, Kidney Transplant Recipient
- How many people
- 236 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
Read the 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).
- Conditions
- CMV Specific Immune Response, Kidney Transplant, Kidney Transplant Recipient, CMV Reactivation
- Keywords
- CMV, Kidney Transplantation, QuantiFERON-CMV, Solid Organ Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Risk factors associated with a non-reactive or indeterminate QF-CMV
Absence of CMV-specific cellular immune response assessed by early QuantiFERON-CMV testing
Measured: Between 15 and 45 days after kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jan 2019
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMV Specific Immune ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621835
- Sponsor's protocol ID
- FCO-PRE-2025-05
- Acronym
- PREDICOR
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07621835
- Acronym / sponsor ID
- PREDICOR / FCO-PRE-2025-05
- Conditions
- CMV Specific Immune Response, Kidney Transplant, Kidney Transplant Recipient, CMV Reactivation
- Keywords
- CMV, Kidney Transplantation, QuantiFERON-CMV, Solid Organ Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk factors associated with a non-reactive or indeterminate QF-CMV
Time frame: Between 15 and 45 days after kidney transplantation
Absence of CMV-specific cellular immune response assessed by early QuantiFERON-CMV testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CMV Specific Immune Response and Kidney Transplant, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors associated with a non-reactive or indeterminate QF-CMV (time frame: Between 15 and 45 days after kidney transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.