/A

Conditions: graft function adapted tacrolimus therapy after liver transplantation
MedDRA version: 14.1Level: LLTClassification code 10024716Term: Liver transplantationSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2011-004944-23-DE

Lead Sponsor: Charité Universitätsmedizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 210

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: number of patients suffering from either toxic or insufficient tacrolimus whole blood troungh level durind the initial 14 days after liver transplantation;Secondary Objective: • Tacrolimus whole blood trough level during post-transplant days 1-14 and week 12<br>• Total cumulative incidence of inadequate tacrolimus whole blood trough levels during post-transplant days 1-14 (<5 ng/mL or >20 ng/mL)<br>• Creatinine serum levels (time frame: post-transplant days 1-14, week 12)<br>• Adverse effects of Prograf®/ Advagraf® (time frame: 12 weeks)<br>o Increase of serum creatinine >50%<br>o Renal failure requiring pharmacological intervention and/ or hemodialysis <br>o Neurological effects including encephalopathy, seizures or coma<br>• Incidence of acute graft rejection (time frame: 12 weeks)<br>• Rejection free time interval (acute cellular rejection) after LT (time frame: 12 weeks)<br>• Assessment of graft survival (time frame: 12 weeks)<br>;Primary end point(s):

Secondary Outcome Measures