Cognitive function after liver transplantation comparing Tacrolimusformulations

Phase 4

Recruiting

Conditions: Immunosuppression post liver transplantation
Z94.4
Liver transplant status

Registration Number: DRKS00021108

Lead Sponsor: niversitätsklinikum Schleswig-Holstein Campus Kiel

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

Written informed consent
- Age 20 to 75 years
- After 12 months post liver transplantation
- Immunosuppression with a twice daily formulation of Tacrolimus
- Application of the same active tacrolimus twice daily formulation since at least 3 months
- At least mild cognitive impairment

Exclusion Criteria

- Dialysis treatment during the previous 30 days
- Defness and / or blindness
- Pregnancy / breastfeeding mothers
- Current participation in another study
- Every other aspect that, in the eye of the investigator, makes the patient unable to comply with study procedures
- Patients taking medications prohibited by the SmPC of Envarsus® and the currently pre-scribed twice daily formulation

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in subjective impression of quality of life concerning attention / concentration and memory between screening and visit 4 (6 months) using the FEDA (self-report questionnaire on attention and memory).

Secondary Outcome Measures

Name	Time	Method
- Cognitive functioning will be assessed using the:<br>1. Trail Making Test - TMT<br>2. Adaptive Digit Ordering Test - DOT-A<br>3. Digit Symbol Test - DST<br>4. Regensburg Stream of Speech Test - RWT<br>5. Victoria Stroop Test - VST<br><br>- Quality of life (QoL) is measured using the SF36<br>- Everyday executive function is measured by BAFQ<br>