Renal TransplantEPIMAC-BELANCT05632523
Early Pharmacological and Immune Monitoring After Conversion to Belatacept in Renal Transplant Patients
An observational study of Renal Transplant and Conversion, run by University Hospital, Tours at 1 site in France.
Trial summary
Single-center, prospective, translational, clinical-biological, multidisciplinary study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant, Conversion
- What is being tested?
- Blood sample and urinary sample
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2023to 6 Nov 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with renal transplant, converted from an anticalcineurin to belatacept at the Tours CHRU.
Who may be able to join
- Age ≥ 18 years
- Renal transplant patient
- Patient converted from an anticalcineurin to belatacept
Who cannot join
- Opposition to data processing
- Hemoglobin < 9g/dL
- Patient under judicial protection
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surveillance Pharmacologique et Immunitaire précoce après Conversion au Belatacept Chez Les Patients Ayant Subi Une Transplantation rénale : étude Pilote
Single-center, prospective, translational, clinical-biological, multidisciplinary study
Read the detailed description
All patients starting belatacept will be informed about non-interventional study and will be included unless they do not accept (non-opposition, consent is not required). Patients will be included and followed up during the 6 first months, i.e. 9 infusions. Blood samples (3 heparinized tubes of 7ml + 1 dry tube without separator gel of 5ml, i.e. 26ml maximum per sample) and urine samples will be harvested before each perfusions and in case of rejection. Clinical and biological data will be collected in an electronic CRF.
- Conditions
- Renal Transplant, Conversion
- Being tested
- Blood sample, urinary sample
- Keywords
- Blood sample, Urinary sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Blood samples are taken at each visit to the day hospital for a programmed belatacept perfusion
urinary sampleOther
Urinary samples are taken at each visit to the day hospital for a programmed belatacept perfusion
| Study group | Role | What they receive |
|---|---|---|
| adult patients with renal transplant | Conversion from anticalcineurin to belatacept Receives: Other: Blood sample; Other: urinary sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphocyte subpopulations in blood before freezing
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Day 0
Lymphocyte subpopulations in blood before freezing
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Day 14
Lymphocyte subpopulations in blood before freezing
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Day 28
Lymphocyte subpopulations in blood before freezing
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Day 42
Lymphocyte subpopulations in blood before freezing
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 2
Lymphocyte subpopulations in blood before freezing
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 3
Lymphocyte subpopulations in blood before freezing
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 4
Lymphocyte subpopulations in blood before freezing
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 5
Lymphocyte subpopulations in blood before freezing
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 6
Lymphocyte subpopulations in blood after freezing
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Day 0
Lymphocyte subpopulations in blood after freezing
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Day 14
Lymphocyte subpopulations in blood after freezing
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Day 28
Lymphocyte subpopulations in blood after freezing
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Day 42
Lymphocyte subpopulations in blood after freezing
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 2
Lymphocyte subpopulations in blood after freezing
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 3
Lymphocyte subpopulations in blood after freezing
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 4
Lymphocyte subpopulations in blood after freezing
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 5
Lymphocyte subpopulations in blood after freezing
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 6
Lymphocyte subpopulations in urine before freezing.
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Day 0
Lymphocyte subpopulations in urine before freezing.
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Day 14
Lymphocyte subpopulations in urine before freezing.
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Day 28
Lymphocyte subpopulations in urine before freezing.
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Day 42
Lymphocyte subpopulations in urine before freezing.
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 2
Lymphocyte subpopulations in urine before freezing.
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 3
Lymphocyte subpopulations in urine before freezing.
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 4
Lymphocyte subpopulations in urine before freezing.
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 5
Lymphocyte subpopulations in urine before freezing.
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 6
Lymphocyte subpopulations in urine after freezing.
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Day 0
Lymphocyte subpopulations in urine after freezing.
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Day 14
Lymphocyte subpopulations in urine after freezing.
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Day 28
Lymphocyte subpopulations in urine after freezing.
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Day 42
Lymphocyte subpopulations in urine after freezing.
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 2
Lymphocyte subpopulations in urine after freezing.
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 3
Lymphocyte subpopulations in urine after freezing.
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 4
Lymphocyte subpopulations in urine after freezing.
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 5
Lymphocyte subpopulations in urine after freezing.
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Measured: Month 6
Secondary outcomes (9)
residual concentrations of belatacept
pharmacological analyses by mass spectrometry
Measured: Day 0
residual concentrations of belatacept
pharmacological analyses by mass spectrometry
Measured: Day 14
residual concentrations of belatacept
pharmacological analyses by mass spectrometry
Measured: Day 28
residual concentrations of belatacept
pharmacological analyses by mass spectrometry
Measured: Day 42
residual concentrations of belatacept
pharmacological analyses by mass spectrometry
Measured: Month 2
residual concentrations of belatacept
pharmacological analyses by mass spectrometry
Measured: Month 3
residual concentrations of belatacept
pharmacological analyses by mass spectrometry
Measured: Month 4
residual concentrations of belatacept
pharmacological analyses by mass spectrometry
Measured: Month 5
residual concentrations of belatacept
pharmacological analyses by mass spectrometry
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start13 Dec 2023
- Primary completion6 Nov 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe GATAULT, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632523
- Sponsor's protocol ID
- DR210053
- Acronym
- EPIMAC-BELA
- Status last verified
- Aug 2025
- First submitted
- 7 Nov 2022
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance Pharmacologique et Immunitaire précoce après Conversion au Belatacept Chez Les Patients Ayant Subi Une Transplantation rénale : étude Pilote
- ClinicalTrials.gov ID
- NCT05632523
- Acronym / sponsor ID
- EPIMAC-BELA / DR210053
- Conditions
- Renal Transplant, Conversion
- Keywords
- Blood sample, Urinary sample
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 30 Nov 2022 (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.
Single-center, prospective, translational, clinical-biological, multidisciplinary study
Detailed description
All patients starting belatacept will be informed about non-interventional study and will be included unless they do not accept (non-opposition, consent is not required). Patients will be included and followed up during the 6 first months, i.e. 9 infusions. Blood samples (3 heparinized tubes of 7ml + 1 dry tube without separator gel of 5ml, i.e. 26ml maximum per sample) and urine samples will be harvested before each perfusions and in case of rejection. Clinical and biological data will be collected in an electronic CRF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients with renal transplant | – | Other: Blood sample, Other: urinary sampleConversion from anticalcineurin to belatacept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with renal transplant, converted from an anticalcineurin to belatacept at the Tours CHRU.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Renal transplant patient
- Patient converted from an anticalcineurin to belatacept
Key exclusion criteria (4 listed)
- Opposition to data processing
- Hemoglobin < 9g/dL
- Patient under judicial protection
- Pregnant or breastfeeding woman
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 sampleBlood samples are taken at each visit to the day hospital for a programmed belatacept perfusion | Other | adult patients with renal transplant |
| urinary sampleUrinary samples are taken at each visit to the day hospital for a programmed belatacept perfusion | Other | adult patients with renal transplant |
Primary outcome
Lymphocyte subpopulations in blood before freezing
Time frame: Day 0
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood before freezing
Time frame: Day 14
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood before freezing
Time frame: Day 28
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood before freezing
Time frame: Day 42
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood before freezing
Time frame: Month 2
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood before freezing
Time frame: Month 3
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood before freezing
Time frame: Month 4
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood before freezing
Time frame: Month 5
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood before freezing
Time frame: Month 6
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood after freezing
Time frame: Day 0
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood after freezing
Time frame: Day 14
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood after freezing
Time frame: Day 28
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood after freezing
Time frame: Day 42
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood after freezing
Time frame: Month 2
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood after freezing
Time frame: Month 3
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood after freezing
Time frame: Month 4
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood after freezing
Time frame: Month 5
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood after freezing
Time frame: Month 6
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine before freezing.
Time frame: Day 0
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine before freezing.
Time frame: Day 14
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine before freezing.
Time frame: Day 28
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine before freezing.
Time frame: Day 42
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine before freezing.
Time frame: Month 2
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine before freezing.
Time frame: Month 3
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine before freezing.
Time frame: Month 4
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine before freezing.
Time frame: Month 5
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine before freezing.
Time frame: Month 6
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine after freezing.
Time frame: Day 0
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine after freezing.
Time frame: Day 14
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine after freezing.
Time frame: Day 28
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine after freezing.
Time frame: Day 42
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine after freezing.
Time frame: Month 2
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine after freezing.
Time frame: Month 3
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine after freezing.
Time frame: Month 4
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine after freezing.
Time frame: Month 5
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine after freezing.
Time frame: Month 6
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
9 secondary outcomes
residual concentrations of belatacept
Time frame: Day 0
residual concentrations of belatacept
Time frame: Day 14
residual concentrations of belatacept
Time frame: Day 28
residual concentrations of belatacept
Time frame: Day 42
residual concentrations of belatacept
Time frame: Month 2
residual concentrations of belatacept
Time frame: Month 3
residual concentrations of belatacept
Time frame: Month 4
residual concentrations of belatacept
Time frame: Month 5
residual concentrations of belatacept
Time frame: Month 6
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 11 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Philippe GATAULT principal investigator
University Hospital, Tours
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 Renal Transplant and Conversion, run by University Hospital, Tours 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 3 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: finished, as of the sponsor's last update on 11 Aug 2025. 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?
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?
Lymphocyte subpopulations in blood before freezing (time frame: Day 0). The study lists 36 primary outcomes in all. 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 11 Aug 2025.