Ignite Creation Date:
2024-05-06 @ 2:08 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04224350
Status:
UNKNOWN
Last Update Posted:
2020-01-13
First Post:
2020-01-08
Brief Title:
Study to Evaluate the Efficacy and Safety of Tacrolimus in Kidney Transplant Recipients BLOSSOM
Sponsor:
Chong Kun Dang Pharmaceutical
Organization:
Chong Kun Dang Pharmaceutical
Study Overview
Official Title:
Multi Center Randomized Open-label Phase IV Study to Compare the Efficacy and Safety After Conversion to TacroBell SR Capsule or TacroBell Capsule in Renal Transplant Patients Undergoing Maintenance Therapy With Reference Tacrolimus
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
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 efficacy and Safety after conversion to TacroBell SR cap or TacroBell cap in patients who in renal transplant patients undergoing maintenance therapy with Reference Tacrolimus
Detailed Description:
This study is a multi-center Randomized Open-label and phase IV clinical trial that evaluates the efficacy and safety after conversion to TacroBell SR cap or TacroBell cap administration for 24 weeks in renal transplant patients undergoing maintenance therapy with Reference Tacrolimus
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