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Single-center, prospective, translational, clinical-biological, multidisciplinary study
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adult patients with renal transplant | Conversion from anticalcineurin to belatacept |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Other | Blood samples are taken at each visit to the day hospital for a programmed belatacept perfusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lymphocyte subpopulations in blood before freezing | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Day 0 |
| Lymphocyte subpopulations in blood before freezing | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Day 14 |
| Lymphocyte subpopulations in blood before freezing | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Day 28 |
| Lymphocyte subpopulations in blood before freezing | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Day 42 |
| Lymphocyte subpopulations in blood before freezing | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 2 |
| Lymphocyte subpopulations in blood before freezing | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 3 |
| Lymphocyte subpopulations in blood before freezing | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| residual concentrations of belatacept | pharmacological analyses by mass spectrometry | Day 0 |
| residual concentrations of belatacept | pharmacological analyses by mass spectrometry |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with renal transplant, converted from an anticalcineurin to belatacept at the Tours CHRU.
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| Name | Affiliation | Role |
|---|---|---|
| Philippe GATAULT | University Hospital, Tours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital | Tours | 37000 | France |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood and urinary
| urinary sample | Other | Urinary samples are taken at each visit to the day hospital for a programmed belatacept perfusion |
|
| Lymphocyte subpopulations in blood before freezing | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 5 |
| Lymphocyte subpopulations in blood before freezing | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 6 |
| Lymphocyte subpopulations in blood after freezing | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Day 0 |
| Lymphocyte subpopulations in blood after freezing | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Day 14 |
| Lymphocyte subpopulations in blood after freezing | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Day 28 |
| Lymphocyte subpopulations in blood after freezing | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Day 42 |
| Lymphocyte subpopulations in blood after freezing | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 2 |
| Lymphocyte subpopulations in blood after freezing | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 3 |
| Lymphocyte subpopulations in blood after freezing | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 4 |
| Lymphocyte subpopulations in blood after freezing | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 5 |
| Lymphocyte subpopulations in blood after freezing | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 6 |
| Lymphocyte subpopulations in urine before freezing. | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Day 0 |
| Lymphocyte subpopulations in urine before freezing. | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Day 14 |
| Lymphocyte subpopulations in urine before freezing. | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Day 28 |
| Lymphocyte subpopulations in urine before freezing. | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Day 42 |
| Lymphocyte subpopulations in urine before freezing. | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 2 |
| Lymphocyte subpopulations in urine before freezing. | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 3 |
| Lymphocyte subpopulations in urine before freezing. | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 4 |
| Lymphocyte subpopulations in urine before freezing. | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 5 |
| Lymphocyte subpopulations in urine before freezing. | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 6 |
| Lymphocyte subpopulations in urine after freezing. | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Day 0 |
| Lymphocyte subpopulations in urine after freezing. | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Day 14 |
| Lymphocyte subpopulations in urine after freezing. | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Day 28 |
| Lymphocyte subpopulations in urine after freezing. | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Day 42 |
| Lymphocyte subpopulations in urine after freezing. | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 2 |
| Lymphocyte subpopulations in urine after freezing. | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 3 |
| Lymphocyte subpopulations in urine after freezing. | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 4 |
| Lymphocyte subpopulations in urine after freezing. | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 5 |
| Lymphocyte subpopulations in urine after freezing. | Variability in absolute counts and relative proportions immunological analyses in flow cytometry | Month 6 |
| Day 14 |
| residual concentrations of belatacept | pharmacological analyses by mass spectrometry | Day 28 |
| residual concentrations of belatacept | pharmacological analyses by mass spectrometry | Day 42 |
| residual concentrations of belatacept | pharmacological analyses by mass spectrometry | Month 2 |
| residual concentrations of belatacept | pharmacological analyses by mass spectrometry | Month 3 |
| residual concentrations of belatacept | pharmacological analyses by mass spectrometry | Month 4 |
| residual concentrations of belatacept | pharmacological analyses by mass spectrometry | Month 5 |
| residual concentrations of belatacept | pharmacological analyses by mass spectrometry | Month 6 |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |