Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365437
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-10
Brief Title:
A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation
Sponsor:
ITB-Med LLC
Organization:
ITB-Med LLC
Study Overview
Official Title:
A 12-Month Randomized Controlled Open-Label Dose Escalation Study Evaluating Safety Tolerability Pharmacokinetics PK and Pharmacodynamics PD of an Anti-CD2 Monoclonal Antibody TCD601Siplizumab Compared to Anti-thymocyte Globulin rATG as Induction Therapy in de Novo Renal Transplant Recipients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
The purpose of this study is to investigate the safety tolerability pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients
Detailed Description:
None
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