Kidney TransplantationIMMCMVNCT06976008
CMV-associated Immunomodulation in Renal Transplant Patients
A study testing blood sampling in people with Kidney Transplantation, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
Cytomegalovirus (CMV) infection has been associated with an increased risk of bacterial, fungal and viral infections in solid organ transplant recipients. The purpose of this study to evaluate if the occurrence of CMV viremia modify the ability to develop optimal immune responses against other pathogens in kidney… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Oct 2025to 1 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- st cohort :
- Age > 18 years
- patients with end-stage renal failure programmed for kidney transplantation with a live donor
- nd cohort :
- Age > 18 years
- kidney transplant recipient with CMV viremia
Who cannot join
- Patients under guardianship, curatorship, legal protection.
- For patients with end-stage renal failure scheduled to receive a kidney transplant from a living donor :
- Patients with an active viral (other than CMV), bacterial or fungal infection at the time of inclusion
- patients receiving a desensitization protocol (ABO or anti-HLA)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Renaud Snanoudj, MD, PhD, 0145212721 ext. +33, renaud.snanoudj@aphp.fr
Hôpital européen Georges Pompidou
Paris, 75015
Eric Thervet, M.D., PhD, 0156095700 ext. +33, eric.thervet@aphp.fr
Hôpital Necker-Enfants Malades
Paris, 75015
Alexandra Serris, MD, PhD, +33144381799, alexandra.serris@aphp.fr
Serris
Insitut Pasteur
Paris, 75015
Alexandra Serris, MD, PhD, +33144381799, alexandra.serris@aphp.fr
Serris
About this study
Cytomegalovirus (CMV) infection has been associated with an increased risk of bacterial, fungal and viral infections in solid organ transplant recipients. The purpose of this study to evaluate if the occurrence of CMV viremia modify the ability to develop optimal immune responses against other pathogens in kidney transplant recipients (heterologous immunity). The objective of this project is to identify the immune pathways affected by CMV in the context of immunosuppression associated with kidney transplantation.
Read the detailed description
Cytomegalovirus (CMV) infection remains one of the most frequent and problematic complications of solid organ transplantation. Several epidemiological studies have shown an association between CMV infection and the occurrence of severe bacterial or fungal infections. However, the mechanisms by which CMV increases the risk of heterologous infection are still poorly understood. Several data support a direct or indirect immunomodulatory effect of CMV. Indeed, in healthy subjects, CMV seropositivity has a strong phenotypic and functional impact on adaptive immunity while in solid organ transplant patients, a decrease in the innate response to various antigenic stimuli has been observed during CMV viremia. The hypothesis of the study is that the occurrence of CMV viremia reduces the ability to develop optimal immune responses against other targeted pathogens in kidney transplant recipients (heterologous immunity). The objective of this project is to identify the immune pathways affected by CMV in the context of immunosuppression associated with kidney transplantation.
- Conditions
- Kidney Transplantation
- Being tested
- blood sampling
- Keywords
- Kidney transplant, Solid organ transplantation, Cytomegalovirus infection, Immunomodulatory effect of cytomegalovirus infection, Heterologous infection
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
Blood samples will be taken at different timepoints following CMV viremia to evaluate the impact of CMV viremia over time.
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplant recipients followed since the day of the transplantation | Experimental | Kidney transplant recipients followed since the day of the transplantation Receives: Other: blood sampling |
| kidney transplant recipients with CMV viremia | Experimental | kidney transplant recipients with CMV viremia Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of CMV infection on the heterologous innate immune response in kidney transplant patients
Comparison of the amount of cytokine production after stimulation of innate immune cells with whole microorganisms (E. Coli, Candida, Aspergillus, influenza virus) in solid organ transplant recipients with and without CMV over time.
Measured: 12 months
Secondary outcomes (1)
Impact of CMV infection on the heterologous adaptive immune response in kidney transplant patients
Comparison of the amount of cytokine production after stimulation of adaptative immune cells with a T-cell superantigen and CMV proteins in solid organ transplant recipients with and without CMV over time.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Alexandra Serris, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976008
- Sponsor's protocol ID
- APHP240837
- Other IDs
- ID-RCB Number : 2024-A01039-38
- Acronym
- IMMCMV
- Status last verified
- Sep 2025
- First submitted
- 9 May 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CMV-associated Immunomodulation in Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT06976008
- Acronym / sponsor ID
- IMMCMV / APHP240837
- Conditions
- Kidney Transplantation
- Keywords
- Kidney transplant, Solid organ transplantation, Cytomegalovirus infection, Immunomodulatory effect of cytomegalovirus infection, Heterologous infection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 16 May 2025 (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.
Cytomegalovirus (CMV) infection has been associated with an increased risk of bacterial, fungal and viral infections in solid organ transplant recipients. The purpose of this study to evaluate if the occurrence of CMV viremia modify the ability to develop optimal immune responses against other pathogens in kidney transplant recipients (heterologous immunity). The objective of this project is to identify the immune pathways affected by CMV in the context of immunosuppression associated with kidney transplantation.
Detailed description
Cytomegalovirus (CMV) infection remains one of the most frequent and problematic complications of solid organ transplantation. Several epidemiological studies have shown an association between CMV infection and the occurrence of severe bacterial or fungal infections. However, the mechanisms by which CMV increases the risk of heterologous infection are still poorly understood. Several data support a direct or indirect immunomodulatory effect of CMV. Indeed, in healthy subjects, CMV seropositivity has a strong phenotypic and functional impact on adaptive immunity while in solid organ transplant patients, a decrease in the innate response to various antigenic stimuli has been observed during CMV viremia. The hypothesis of the study is that the occurrence of CMV viremia reduces the ability to develop optimal immune responses against other targeted pathogens in kidney transplant recipients (heterologous immunity). The objective of this project is to identify the immune pathways affected by CMV in the context of immunosuppression associated with kidney transplantation.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant recipients followed since the day of the transplantation | Experimental | Other: blood samplingKidney transplant recipients followed since the day of the transplantation |
| kidney transplant recipients with CMV viremia | Experimental | Other: blood samplingkidney transplant recipients with CMV viremia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- st cohort :
- nd cohort :
Key exclusion criteria (4 listed)
- Patients under guardianship, curatorship, legal protection.
- For patients with end-stage renal failure scheduled to receive a kidney transplant from a living donor :
- Patients with an active viral (other than CMV), bacterial or fungal infection at the time of inclusion
- patients receiving a desensitization protocol (ABO or anti-HLA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingBlood samples will be taken at different timepoints following CMV viremia to evaluate the impact of CMV viremia over time. | Other | Kidney transplant recipients followed since the day of the transplantation, kidney transplant recipients with CMV viremia |
Primary outcome
Impact of CMV infection on the heterologous innate immune response in kidney transplant patients
Time frame: 12 months
Comparison of the amount of cytokine production after stimulation of innate immune cells with whole microorganisms (E. Coli, Candida, Aspergillus, influenza virus) in solid organ transplant recipients with and without CMV over time.
1 secondary outcome
Impact of CMV infection on the heterologous adaptive immune response in kidney transplant patients
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Alexandra Serris principal investigator
Assistance Publique - Hôpitaux de Paris
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling in people with Kidney Transplantation, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Serris, MD, PhD (0144 381799 ext. +33, alexandra.serris@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of CMV infection on the heterologous innate immune response in kidney transplant patients (time frame: 12 months). 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 12 Sep 2025.