Ignite Creation Date:
2024-05-06 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03644485
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2018-08-22
Brief Title:
Clinical Outcome of Delayed or Standard Prograf Together With Induction Therapy Followed by Conversion to Advagraf in Donation After Cardiac or Circulatory Death DCD Kidney Transplant Recipients
Sponsor:
Astellas Pharma China Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
Clinical Outcome of Delayed or Standard Prograf Together With Induction Therapy Followed by Conversion to Advagraf in Donation After Cardiac or Circulatory Death DCD Kidney Transplant Recipients A Randomized Open-label Multicenter Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-12
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 confirm non-inferiority of delayed Prograf treatment to standard Prograf treatment in the incidence of delayed graft function DGF within 1 week between the 2 immunosuppressive IS treatment groups delayed or standard Prograf together with induction therapy and then convert to Advagraf usage in donation after cardiac or circulatory death DCD kidney transplant recipients
This study will also compare the clinical outcome within 6 month post-transplant between the 2 IS treatment groups and compare the safety throughout study period between the 2 IS treatment groups
This study will also compare the clinical outcome within 6 month post-transplant between the 2 IS treatment groups and compare the safety throughout study period between the 2 IS treatment groups
Detailed Description:
None
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