Ignite Creation Date:
2025-12-18 @ 8:21 AM
Ignite Modification Date:
2025-12-18 @ 8:21 AM
Study NCT ID:
NCT05632523
Status:
None
Last Update Posted:
2025-08-11 00:00:00
First Post:
2022-11-07 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Pharmacological and Immune Monitoring After Conversion to Belatacept in Renal Transplant Patients
Sponsor:
None
Organization:
Study Overview
Official Title:
Surveillance Pharmacologique et Immunitaire précoce après Conversion au Belatacept Chez Les Patients Ayant Subi Une Transplantation rénale : étude Pilote
Status:
None
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPIMAC-BELA
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: