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

Recruiting

• Conditions: Renal Transplant; Conversion
• Interventions: Other: Blood sample; Other: urinary sample

• Registration Number: NCT05632523
• Lead Sponsor: University Hospital, Tours

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.

Study Timeline

• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-18
• Study First Posted: 2022-11-30
• Study Start: 2023-12-13
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
adult patients with renal transplant	Blood sample	Conversion from anticalcineurin to belatacept
adult patients with renal transplant	urinary sample	Conversion from anticalcineurin to belatacept

Primary Outcome Measures

Name	Time	Method
Lymphocyte subpopulations in blood before freezing	Month 6	Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood after freezing	Month 6	Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine before freezing.	Month 6	Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine after freezing.	Month 6	Variability in absolute counts and relative proportions immunological analyses in flow cytometry

Secondary Outcome Measures

Name	Time	Method
residual concentrations of belatacept	Month 6	pharmacological analyses by mass spectrometry

Trial Locations

Locations (1)

University hospital; 🇫🇷 Tours, France