Ignite Creation Date:
2024-05-06 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03663335
Status:
COMPLETED
Last Update Posted:
2022-06-13
First Post:
2018-06-04
Brief Title:
Study of Efficacy Safety Tolerability Pharmacokinetic PK and Pharmacodynamic PD of an Anti-CD40 Monoclonal Antibody CFZ533 in Kidney Transplant Recipients
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Partially-blinded Active-controlled Multicenter Randomized Study Evaluating Efficacy Safety Tolerability Pharmacokinetic PK and Pharmacodynamic PD of an Anti-CD40 Monoclonal Antibody CFZ533 in de Novo and Maintenance Kidney Transplant Recipients CIRRUS I
Status:
COMPLETED
Status Verified Date:
2022-06
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:
CIRRUS I
Brief Summary:
The purpose of this study is to investigate the safety efficacy pharmacokinetics PK and pharmacodynamics PD of three CFZ533 dose regimens in kidney transplant recipients
This study will allow assessment of the ability of CFZ533 to replace Calcineurin inhibitors CNIs in terms of anti-rejection efficacy while providing better renal function with a better safety and tolerability profile Results of this study will be used to inform the CFZ533 dose and regimen selection for investigation in later phases of clinical development
This study will allow assessment of the ability of CFZ533 to replace Calcineurin inhibitors CNIs in terms of anti-rejection efficacy while providing better renal function with a better safety and tolerability profile Results of this study will be used to inform the CFZ533 dose and regimen selection for investigation in later phases of clinical development
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-003607-22 | EUDRACT_NUMBER | None | None |
| CCFZ533A2201 | OTHER | None | None |
| 03663335 | OTHER | Clinicaltrialsgov | None |