Cognitive function after liver transplantation comparing Tacrolimus formulations

Phase 1

• Conditions: Immunosuppression post liver transplantation; MedDRA version: 21.0Level: LLTClassification code 10024716Term: Liver transplantationSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2018-004043-23-DE
• Lead Sponsor: niversity Hospital Schleswig-Holstein (UKSH)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-15
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

- Written informed consent
- Age 20 to 70 years
- After 12 months post liver transplantation
- Immunosuppression with a twice daily formulation of Tacrolimus
- Application of the same active tacrolimus twice daily formulation =3 months
- At least mild cognitive impairment (TMT: at least one standard deviation above the age-specific mean for TMT Test B)

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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Dialysis treatment during the previous 30 days
- Deafness and/or blindness
- Pregnancy/breastfeeding mothers
- Current participation in another study
- Every other aspect that, in the eye of investigator, makes the patient unable to comply with study procedures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified