Early Pharmacological and Immune Monitoring After Conversion to Belatacept in Renal Transplant Patients

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Surveillance Pharmacologique et Immunitaire précoce après Conversion au Belatacept Chez Les Patients Ayant Subi Une Transplantation rénale : étude Pilote

Conditions
-----------------
Renal Transplant, Conversion

Intervention / Treatment
-----------------
* Other: Blood sample
* Other: urinary sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Renal transplant patient Patient converted from an anticalcineurin to belatacept Exclusion Criteria: Opposition to data processing Hemoglobin < 9g/dL Patient under judicial protection Pregnant or breastfeeding woman

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| adult patients with renal transplant<br>Conversion from anticalcineurin to belatacept | Other: Blood sample<br>* Blood samples are taken at each visit to the day hospital for a programmed belatacept perfusion<br>Other: urinary sample<br>* Urinary samples are taken at each visit to the day hospital for a programmed belatacept perfusion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| residual concentrations of belatacept | pharmacological analyses by mass spectrometry | Day 0 | 
| residual concentrations of belatacept | pharmacological analyses by mass spectrometry | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood sample, Urinary sample