Ignite Creation Date:
2024-07-17 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461546
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-11
Brief Title:
Imlifidase in Living Donor Renal Transplantation Highly Sensitized Recipients
Sponsor:
Fundacion Clinic per a la Recerca Biomédica
Organization:
Fundacion Clinic per a la Recerca Biomédica
Study Overview
Official Title:
Imlifidase in Living Donor Renal Transplantation Highly Sensitized Recipients LIVEDES
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
LIVEDES
Brief Summary:
This is a Phase II pilot prospective unicentric trial to evaluate Imlifidase could improve the transplantability of the highly sensitized patients with good outcomes respect to survival and functionality of the graft
Detailed Description:
The patients between 18 and 65 years will be flow cytometry crossmatch FC-XM positive against an available living donor The imlifidase treatment will turn the crossmatch test negative prior to transplantation A second dose of imlifidase can be given within 24 hours if the first dose is considered not to have sufficient effect If a second dose is given a confirmatory FCXM test will be performed pre-second imlifidase dosing and between 2-6 hours following the second dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-513607-14-00 | CTIS | None | None |