Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06147648
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-27
First Post:
2023-10-12
Brief Title:
Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation
Sponsor:
Beijing Tsinghua Chang Gung Hospital
Organization:
Beijing Tsinghua Chang Gung Hospital
Study Overview
Official Title:
Prospective Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Liver Transplant Recipients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
Tacrolimus is a commonly used immunosuppressant after liver transplantation A once-daily administration of prolonged-release tacrolimus has been found to improve patient compliance and offer good efficacy and safety Moreover there is evidence that this prolonged-release formulation mitigates renal impairment and metabolic syndrome in transplant recipients Foreign studies have confirmed that it is safe and feasible for liver transplant recipients to switch from immediate-release tacrolimus to prolonged-release tacrolimus during the stable period At the same time patients with early conversion are more likely to benefit in terms of graft survival and renal function recovery and the proportion of drug conversion needs to be further explored
This study aims to assess the efficacy and safety of switching from immediate-release tacrolimus to prolonged-release tacrolimus three months after liver transplantation Furthermore it seeks to investigate the impact of this conversion on indicators such as liver function kidney function metabolic disease incidence and infection incidence in patients
This study aims to assess the efficacy and safety of switching from immediate-release tacrolimus to prolonged-release tacrolimus three months after liver transplantation Furthermore it seeks to investigate the impact of this conversion on indicators such as liver function kidney function metabolic disease incidence and infection incidence in patients
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