Early Pharmacological and Immune Monitoring After Conversion to Belatacept in Renal Transplant Patients (EPIMAC-BELA)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Conversion; Renal Transplant

Treatments: Other: Blood sample; Other: urinary sample

Study type: Observational

Funder types: Other

Identifiers

NCT05632523

DR210053

Details and patient eligibility

About

Single-center, prospective, translational, clinical-biological, multidisciplinary study

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

adult patients with renal transplant

Description:

Conversion from anticalcineurin to belatacept

Treatment:

Other: urinary sample

Other: Blood sample