Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-04 @ 5:57 PM
Study NCT ID:
NCT01666951
Status:
COMPLETED
Last Update Posted:
2015-07-07
First Post:
2012-08-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant
Sponsor:
Veloxis Pharmaceuticals
Organization:
Study Overview
Official Title:
Ph 2 Double-blind, Double-dummy, Multicenter, Prospective, Rand Study of PK of LCP-Tacro™ Tablets Once Daily, Compared to Prograf® Caps, Twice Daily, for Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2015-06
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:
None
Brief Summary:
The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation.
Detailed Description:
This is a 2-arm , parallel group, prospective, double-blind, double-dummy, multicenter,clinical trial to evaluate the pharmacokinetics of LCP-Tacro tablets once daily in comparison to Prograf capsules twice-daily after kidney transplantation.
Study Oversight
Has Oversight DMC:
False
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?: