Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321074
Status:
COMPLETED
Last Update Posted:
2014-08-26
First Post:
2006-05-01
Brief Title:
Tacrolimus and Daclizumab Versus Tacrolimus and Steroids in Liver Recipients Receiving Sub-optimal Grafts
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
AN OPEN MULTICENTRE RANDOMISED PARALLEL GROUP CLINICAL STUDY TO COMPARE SAFETY AND EFFICACY OF TACROLIMUS FK506 WITH MONOCLONAL ANTI-IL2R ANTIBODIES DACLIZUMAB VS TACROLIMUS FK506 WITH STEROIDS AND EVALUATE PHARMACOKINETICS IN LIVER ALLOGRAFT RECIPIENTS RECEIVING SUBOPTIMAL LIVERS
Status:
COMPLETED
Status Verified Date:
2014-08
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:
PANTERA
Brief Summary:
The purpose of the study is to compare the safety and efficacy of two different tacrolimus based immunosuppressive regimens one in combination with daclizumab the other in combination with steroids in recipients of suboptimal livers
Pharmacokinetics of tacrolimus and bile composition will be measured in a subgroup of patients
Pharmacokinetics of tacrolimus and bile composition will be measured in a subgroup of patients
Detailed Description:
Open multicentre 11 randomised parallel group phase III study to compare safety and efficacy of tacrolimus FK506 with monoclonal anti-IL2R antibodies daclizumab vs tacrolimus FK506 with steroids and evaluate pharmacokinetics in liver allograft recipients receiving suboptimal livers
Patients receiving primary suboptimal liver allograft transplantation from donors 65 years andor liver macrosteatosis 15 will be randomised to one of the following treatment arms
Group I steroid bolus intraoperative monoclonal anti-IL2R antibodies daclizumab induction tacrolimus Group II steroid bolus intraoperative tacrolimus steroids
Patients receiving primary suboptimal liver allograft transplantation from donors 65 years andor liver macrosteatosis 15 will be randomised to one of the following treatment arms
Group I steroid bolus intraoperative monoclonal anti-IL2R antibodies daclizumab induction tacrolimus Group II steroid bolus intraoperative tacrolimus steroids
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