NCT05632523 - Early Pharmacological and Immune Monitoring After Conversion to Belatacept in Renal Transplant Patients | Crick | Crick

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

N/ACompletedNCT05632523

University Hospital, Tours10 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

10

Conditions

Renal Transplant Conversion

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University hospital

Tours, France

Outcomes

Primary Outcomes

Lymphocyte subpopulations in blood before freezing

Variability in absolute counts and relative proportions immunological analyses in flow cytometry

Time frame: Day 0

Lymphocyte subpopulations in blood before freezing

Variability in absolute counts and relative proportions immunological analyses in flow cytometry

Time frame: Day 14

Lymphocyte subpopulations in blood before freezing

Variability in absolute counts and relative proportions immunological analyses in flow cytometry

Time frame: Day 28

Lymphocyte subpopulations in blood before freezing

Variability in absolute counts and relative proportions immunological analyses in flow cytometry

Time frame: Day 42

Lymphocyte subpopulations in blood before freezing

Variability in absolute counts and relative proportions immunological analyses in flow cytometry

Time frame: Month 2

Lymphocyte subpopulations in blood before freezing

Variability in absolute counts and relative proportions immunological analyses in flow cytometry

Time frame: Month 3

Lymphocyte subpopulations in blood before freezing

Variability in absolute counts and relative proportions immunological analyses in flow cytometry

Time frame: Month 4

Lymphocyte subpopulations in blood before freezing

Variability in absolute counts and relative proportions immunological analyses in flow cytometry

Data from ClinicalTrials.gov

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