NCT05632523

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Transplant
• Conversion

Interventions

Type	Name	Description
OTHER	Blood sample	Blood samples are taken at each visit to the day hospital for a programmed belatacept perfusion
OTHER	urinary sample	Urinary samples are taken at each visit to the day hospital for a programmed belatacept perfusion

Timeline

• Start date: 2023-12-13
• Primary completion: 2024-11-06
• Completion: 2024-11-06
• First posted: 2022-11-30
• Last updated: 2025-08-11

Locations

1 site across 1 country: France