Ignite Creation Date:
2024-05-06 @ 3:08 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02217410
Status:
COMPLETED
Last Update Posted:
2021-09-28
First Post:
2014-08-07
Brief Title:
CCFZ533X2201 - PoC Study in de Novo Renal Transplantation
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A 12-month Randomized Multiple Dose Open-label Study Evaluating Safety Tolerability PharmacokineticsPharmacodynamics PKPD and Efficacy of an Anti-CD40 Monoclonal Antibody CFZ533 in Combination With Mycophenolate Mofetil MMF and Corticosteroids CS With and Without Tacrolimus Tac in de Novo Renal Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2021-09
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 was to investigate the safety tolerability pharmacokinetics PK and potential for CFZ533 to replace calcineurin inhibitors CNI while providing a similar rate of acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors
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?:
None