Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT04803058
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-08
First Post:
2021-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PERSPECTIVE)
Sponsor:
ITB-Med LLC
Organization:
Study Overview
Official Title:
A Safety and Tolerability Study of TCD601 (Siplizumab), a Human Anti-CD2 Antibody, Combined With Donor Bone Marrow Cell Infusion and Non-Myeloablative Conditioning, Including Fludarabine and Cyclophosphamide, for Tolerance Induction in Living Donor Renal Transplantation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-12
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:
PERSPECTIVE
Brief Summary:
The purpose of this study is to evaluate if TCD601 can induce allogeneic tolerance in living donor renal transplant recipients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: