graft function adapted tacrolimus therapy after liver transplantation (GRAFTT)

Phase 4

Recruiting

• Conditions: livertransplantation; K72.9; Hepatic failure, unspecified

• Registration Number: DRKS00003551
• Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Inclusion criteria
-Patients intended for orthotopic deceased-
donor LT
- Recipient age =18 yrs.
- Capability to understand the purpose and
the risk of the study
- Written informed consent prior LT

Exclusion Criteria

- Participation in other clinical trials during <28 days before LT
- any organ transplantation before enrollment, High-urgent transplantation, split liver LT, living donor LT, combined multi-organ transplantation, AB0 incompatible grafts, retransplantation
- Recipients with malignant tumors beside HCC respecting the Milan criteria or liver metastasis
-Target trough levels of tacrolimus differing from 10-15 ng/mL in the first 14 days after LTx)
- planned use of other immunosuppressive drugs including ciclosporine A, sirolimus, everolimus, azathioprine in the first 14 days after LTx

- patients with known intolerance of tacrolimus
- patients with a history of substance or drug abuse
- patients with psychiatric disorders or any forms of substance abuse not capable of understanding the purpose and risks of the study
- subjects known to be HIV positive- pregnant woman or breastfeeding mother

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of patients suffering from either toxic or insufficient tacrolimus whole blood trough levels during the initial 14 days after liver transplantation<br>(twice levels of <5 ng/mL during post-transplant days 1-14 or one levels >20 ng/mL during post-transplant days 1-14)<br>

Secondary Outcome Measures

Name	Time	Method
1.) Tacrolimus whole blood trough level during post-transplant days 1-14<br><br>2.) Total cumulative incidence of inadequate tacrolimus whole blood trough levels during post-transplant days 1-14 (<5 ng/mL or >20 ng/mL)<br><br>3.) Creatinine serum levels (day 1-14 after transplantation)<br><br>4.) Incidence of Adverse effects:<br>a.) acute renal failure (days 1-14)<br>b.) chronic renal insufficiency (until 1 year after transplantation)<br>c) Neurological effects including <br> encephalopathy, seizures or coma (days 1- 14)<br>5.) graft rejection (time frame: 1 year)<br>6.) Rejection free time interval (time frame: 1 year)<br>7.) Assessment of graft and patient survival (time frame: 1 year)<br>