Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270634
Status:
COMPLETED
Last Update Posted:
2013-02-12
First Post:
2005-12-23
Brief Title:
Study of ISA247 Voclosporin in De Novo Renal Transplantation
Sponsor:
Aurinia Pharmaceuticals Inc
Organization:
Aurinia Pharmaceuticals Inc
Study Overview
Official Title:
A Phase IIb Randomized Multicenter Open-Label Concentration Controlled Safety Study of ISA247 Voclosporin and Tacrolimus Prograf in De Novo Renal Transplant Patients
Status:
COMPLETED
Status Verified Date:
2013-02
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:
PROMISE
Brief Summary:
This study will see if voclosporin is safe and effective in preventing kidney transplant rejection
Detailed Description:
Prograf tacrolimus is associated with numerous side effects including neurotoxicity nephrotoxicity polyoma nephropathy QT prolongation and New Onset Diabetes Mellitus After Transplant NODAT Voclosporin is a novel calcineurin inhibitor intended for use in the prevention of organ graft rejection
Comparisons Voclosporin at 3 dose levels 04 06 and 08 mgkg twice a day compared to tacrolimus
Comparisons Voclosporin at 3 dose levels 04 06 and 08 mgkg twice a day compared to tacrolimus
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