Clinical trial NCT05632523: Early Pharmacological and Immune Monitoring After Conversion to Belatacept in Renal Transplant Patients
Official title: Surveillance Pharmacologique et Immunitaire précoce après Conversion au Belatacept Chez Les Patients Ayant Subi Une Transplantation rénale : étude Pilote
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Transplant
Conversion
Keywords: Blood sample
Urinary sample
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with renal transplant, converted from an anticalcineurin to belatacept at the Tours CHRU.

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.

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

Primary outcomes:
measure: Lymphocyte subpopulations in blood before freezing
timeFrame: Day 0
measure: Lymphocyte subpopulations in blood before freezing
timeFrame: Day 14
measure: Lymphocyte subpopulations in blood before freezing
timeFrame: Day 28
measure: Lymphocyte subpopulations in blood before freezing
timeFrame: Day 42
measure: Lymphocyte subpopulations in blood before freezing
timeFrame: Month 2
measure: Lymphocyte subpopulations in blood before freezing
timeFrame: Month 3
measure: Lymphocyte subpopulations in blood before freezing
timeFrame: Month 4
measure: Lymphocyte subpopulations in blood before freezing
timeFrame: Month 5
measure: Lymphocyte subpopulations in blood before freezing
timeFrame: Month 6
measure: Lymphocyte subpopulations in blood after freezing
timeFrame: Day 0
measure: Lymphocyte subpopulations in blood after freezing
timeFrame: Day 14
measure: Lymphocyte subpopulations in blood after freezing
timeFrame: Day 28
measure: Lymphocyte subpopulations in blood after freezing
timeFrame: Day 42
measure: Lymphocyte subpopulations in blood after freezing
timeFrame: Month 2
measure: Lymphocyte subpopulations in blood after freezing
timeFrame: Month 3
measure: Lymphocyte subpopulations in blood after freezing
timeFrame: Month 4
measure: Lymphocyte subpopulations in blood after freezing
timeFrame: Month 5
measure: Lymphocyte subpopulations in blood after freezing
timeFrame: Month 6
measure: Lymphocyte subpopulations in urine before freezing.
timeFrame: Day 0
measure: Lymphocyte subpopulations in urine before freezing.
timeFrame: Day 14
measure: Lymphocyte subpopulations in urine before freezing.
timeFrame: Day 28
measure: Lymphocyte subpopulations in urine before freezing.
timeFrame: Day 42
measure: Lymphocyte subpopulations in urine before freezing.
timeFrame: Month 2
measure: Lymphocyte subpopulations in urine before freezing.
timeFrame: Month 3
measure: Lymphocyte subpopulations in urine before freezing.
timeFrame: Month 4
measure: Lymphocyte subpopulations in urine before freezing.
timeFrame: Month 5
measure: Lymphocyte subpopulations in urine before freezing.
timeFrame: Month 6
measure: Lymphocyte subpopulations in urine after freezing.
timeFrame: Day 0
measure: Lymphocyte subpopulations in urine after freezing.
timeFrame: Day 14
measure: Lymphocyte subpopulations in urine after freezing.
timeFrame: Day 28
measure: Lymphocyte subpopulations in urine after freezing.
timeFrame: Day 42
measure: Lymphocyte subpopulations in urine after freezing.
timeFrame: Month 2
measure: Lymphocyte subpopulations in urine after freezing.
timeFrame: Month 3
measure: Lymphocyte subpopulations in urine after freezing.
timeFrame: Month 4
measure: Lymphocyte subpopulations in urine after freezing.
timeFrame: Month 5
measure: Lymphocyte subpopulations in urine after freezing.
timeFrame: Month 6
Secondary outcomes:
measure: residual concentrations of belatacept
timeFrame: Day 0
measure: residual concentrations of belatacept
timeFrame: Day 14
measure: residual concentrations of belatacept
timeFrame: Day 28
measure: residual concentrations of belatacept
timeFrame: Day 42
measure: residual concentrations of belatacept
timeFrame: Month 2
measure: residual concentrations of belatacept
timeFrame: Month 3
measure: residual concentrations of belatacept
timeFrame: Month 4
measure: residual concentrations of belatacept
timeFrame: Month 5
measure: residual concentrations of belatacept
timeFrame: Month 6
Other outcomes:
Locations:
city: Tours
country: France
facility: University hospital
Study officials:
affiliation: University Hospital, Tours
name: Philippe GATAULT
role: PRINCIPAL_INVESTIGATOR
References: