Kidney Transplant InfectionVIRABELNCT05708534
Evolution of CMV Antiviral T-cell Immunity Over the Next Six Months Initiation of Treatment With Belatacept.
An observational study of Kidney Transplant Infection, run by University Hospital, Rouen at 1 site in France.
Trial summary
Belatacept inhibits T cell activation by blocking the costimulatory signal. In kidney transplantation, it limits the use of anticalcineurins while ensuring a satisfactory level of immunosuppression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Infection
- What is being tested?
- Belatacept
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2023to 31 May 2027
- Phase
- Observational
- 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
Study population: Cohort of kidney transplant recipients seropositive for CMV
Who may be able to join
- Renal transplant follow-up at Rouen University Hospital
- Clinico-biological intolerance to anticalcineurins defined by GFR < 25 mL/min and/or water and sodium overload justifying the prescription of loop diuretics and/or post-transplant diabetes and/or resistant hypertension (requiring at least 3 treatments antihypertensives including a thiazide diuretic to reach an objective ≤ 140/90 mmHg).
- Having performed a graft biopsy < 3 months old finding lesions of fibrous endarteritis ≥ 2 or arteriolar hyalinosis ≥ 2
- Having undergone collegial validation for the initiation of treatment with belatacept combined with 3-month anti-CMV prophylaxis with oral Valganciclovir.
- Absence of contraindication to belatacept
- Patient who has never received belatacept
- Having a positive CMV serological status
Who cannot join
- Patient with symptomatic infection
- Pregnant or parturient or breast-feeding woman or lack of proven effective contraception
- Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship
- Patient participating in another therapeutic trial or having participated in another trial within 1 month
Trial locations and contacts
1 site in 1 country.
About this study
Belatacept inhibits T cell activation by blocking the costimulatory signal. In kidney transplantation, it limits the use of anticalcineurins while ensuring a satisfactory level of immunosuppression.
Read the detailed description
The Rouen strategy consists of offering belatacept to kidney transplant patients with clinical and laboratory intolerance to anticalcineurins with histological toxicity. This strategy improves or stabilizes the graft's glomerular filtration rate (GFR) in patients with poor renal function. However, a high incidence of opportunistic infections (12.1%), mainly due to CMV, has been observed in elderly patients with a GFR less than 25 ml/min. Two-thirds of CMV infections occur within one year of belatacept initiation and can be particularly severe and life-threatening for both patients and the graft. These results led to the implementation of systematic 3-month antiviral prophylaxis with valganciclovir upon the introduction of belatacept.
CMV immune control depends primarily on virus-specific effector/memory T cells. The impact of costimulation blockade on certain persistent viral infections has been studied experimentally. It is significant when the infection is established, but appears variable in the chronic phase depending on the virus type. Viral load appears to be a determining factor in the size of the antiviral T cell repertoire and its functions (lymphocyte exhaustion). In the case of CMV, the consequences of blocking costimulation on the specific effector/memory T cell pool are unknown.
The hypothesis of this project is that, under belatacept, the influence of CMV on the immune system induces quantitative changes in the effector/memory T cell pool (inflation or, conversely, contraction) and/or functional exhaustion, likely leading to a loss of control of viral replication. This study therefore proposes to investigate the evolution of the anti-CMV response in terms of amplitude, specificity, and functionality, after the introduction of belatacept in CMV-positive patients.
- Conditions
- Kidney Transplant Infection
- Being tested
- Belatacept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelataceptDrug
Switching from anticalcineurins to belatacept in a cohort of kidney transplant recipients seropositive for CMV
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the quantitative changes in anti-CMV T-lymphocyte immunity to the IE-1 antigen within 6 months of a switch from anticalcineurin treatment to belatacept in a cohort of kidney transplant recipients seropositive for CMV
Number of interferon gamma-producing T lymphocytes in response to the IE-1 antigen determined by ELISPOT at M0, M3 and M6.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start14 Nov 2023
- Primary completion13 May 2026
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708534
- Sponsor's protocol ID
- 2020/0432/OB
- Acronym
- VIRABEL
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2023
- Last updated
- 22 May 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of CMV Antiviral T-cell Immunity Over the Next Six Months Initiation of Treatment With Belatacept.
- ClinicalTrials.gov ID
- NCT05708534
- Acronym / sponsor ID
- VIRABEL / 2020/0432/OB
- Conditions
- Kidney Transplant Infection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 13 May 2026 (actual)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 1 Feb 2023 (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.
Belatacept inhibits T cell activation by blocking the costimulatory signal. In kidney transplantation, it limits the use of anticalcineurins while ensuring a satisfactory level of immunosuppression.
Detailed description
The Rouen strategy consists of offering belatacept to kidney transplant patients with clinical and laboratory intolerance to anticalcineurins with histological toxicity. This strategy improves or stabilizes the graft's glomerular filtration rate (GFR) in patients with poor renal function. However, a high incidence of opportunistic infections (12.1%), mainly due to CMV, has been observed in elderly patients with a GFR less than 25 ml/min. Two-thirds of CMV infections occur within one year of belatacept initiation and can be particularly severe and life-threatening for both patients and the graft. These results led to the implementation of systematic 3-month antiviral prophylaxis with valganciclovir upon the introduction of belatacept.
CMV immune control depends primarily on virus-specific effector/memory T cells. The impact of costimulation blockade on certain persistent viral infections has been studied experimentally. It is significant when the infection is established, but appears variable in the chronic phase depending on the virus type. Viral load appears to be a determining factor in the size of the antiviral T cell repertoire and its functions (lymphocyte exhaustion). In the case of CMV, the consequences of blocking costimulation on the specific effector/memory T cell pool are unknown.
The hypothesis of this project is that, under belatacept, the influence of CMV on the immune system induces quantitative changes in the effector/memory T cell pool (inflation or, conversely, contraction) and/or functional exhaustion, likely leading to a loss of control of viral replication. This study therefore proposes to investigate the evolution of the anti-CMV response in terms of amplitude, specificity, and functionality, after the introduction of belatacept in CMV-positive patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of kidney transplant recipients seropositive for CMV
Key inclusion criteria (7 listed)
- Renal transplant follow-up at Rouen University Hospital
- Clinico-biological intolerance to anticalcineurins defined by GFR < 25 mL/min and/or water and sodium overload justifying the prescription of loop diuretics and/or post-transplant diabetes and/or resistant hypertension (requiring at least 3 treatments antihypertensives including a thiazide diuretic to reach an objective ≤ 140/90 mmHg).
- Having performed a graft biopsy < 3 months old finding lesions of fibrous endarteritis ≥ 2 or arteriolar hyalinosis ≥ 2
- Having undergone collegial validation for the initiation of treatment with belatacept combined with 3-month anti-CMV prophylaxis with oral Valganciclovir.
- Absence of contraindication to belatacept
Key exclusion criteria (4 listed)
- Patient with symptomatic infection
- Pregnant or parturient or breast-feeding woman or lack of proven effective contraception
- Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship
- Patient participating in another therapeutic trial or having participated in another trial within 1 month
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 |
|---|---|---|
| BelataceptSwitching from anticalcineurins to belatacept in a cohort of kidney transplant recipients seropositive for CMV | Drug | – |
Primary outcome
To study the quantitative changes in anti-CMV T-lymphocyte immunity to the IE-1 antigen within 6 months of a switch from anticalcineurin treatment to belatacept in a cohort of kidney transplant recipients seropositive for CMV
Time frame: 6 months
Number of interferon gamma-producing T lymphocytes in response to the IE-1 antigen determined by ELISPOT at M0, M3 and M6.
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 22 May 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 Kidney Transplant Infection, run by University Hospital, Rouen at 1 site 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 7 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: under way, not looking for participants, as of the sponsor's last update on 22 May 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 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?
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?
To study the quantitative changes in anti-CMV T-lymphocyte immunity to the IE-1 antigen within 6 months of a switch from anticalcineurin treatment to belatacept in a cohort of kidney transplant recipients seropositive for CMV (time frame: 6 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 22 May 2026.