Ignite Creation Date:
2024-05-06 @ 12:24 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03749356
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2018-11-14
Brief Title:
Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients
Sponsor:
Chong Kun Dang Pharmaceutical
Organization:
Chong Kun Dang Pharmaceutical
Study Overview
Official Title:
Multi Center Non-comparative Phase IV Study to Evaluate the Efficacy and Safety of Once-Daily Prolonged Release Tacrolimus CapsuleTacroBell SR Cap in Kidney Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2021-01
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:
OPIRUS
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety and of Once-Daily Tacrolimus TacroBell SR Cap in patients who received renal transplantation
Detailed Description:
This study is a multi-center non-comparative and phase IV clinical trial that evaluates the efficacy and safety of combined Once-Daily Tacrolimus TacroBell SR Cap administration for 24 weeks in patients with immunosuppressive therapies after renal transplantation
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