Immunosuppression post liver transplantation MedDRA version: 21.0 Level: LLT Classification code 10024716 Term: Liver transplantation System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Envarsus 0.75 mg
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: TACROLIMUS
CAS Number: 104987-11-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
University Hospital Schleswig-Holstein (UKSH)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether once-daily formulation of tacrolimus (Envarsus®) improves subjective impression of attention and memory performance compared to twice-daily formulation of tacrolimus [time frame: 6 months].;Secondary Objective: (1) To determine whether once-daily formulation of tacrolimus improves cognitive functions compared to twice-daily formulation [time frame: 6 and 12 months]. (2) To determine whether once-daily formulation of tacrolimus improves quality of life (QoL) compared to twice-daily formulation [time frame: 6 and 12 months]. (3) To determine whether once-daily formulation of tacrolimus improves everyday executive function compared to twice-daily formulation [time frame 6 and 12 months]. (4) To assess the impact on safety-parameters including AEs, clinical significant liver and kidney function. (5) To investigate whether there is a change in Tacrolimus trough levels over time within the groups. (6) To assess the correlation between Tacrolimus trough levels and cognitive functions at each time point separated for both study arms.;Primary end point(s): 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).;Timepoint(s) of evaluation of this end point: Change between screening and Visit 4 (month 6) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Cognitive function is assessed using the: 1. Trail Making Test – TMT 2. Adaptive Digit Ordering Test – DOT-A 3. Digit Symbol Test – DST 4. Regensburg Stream of Speech Test – RWT 5. Victoria Stroop Test – VST - Quality of life (QoL) is measured using the SF36 - Everyday executive function is measured by BAFQ ;Timepoint(s) of evaluation of this end point: Cognitive function will be assessed at visit 3 (month 6) and visit 5 (month 12) Quality of life (QoL) will be assessed at visit 3 (month 6) and visit 5 (month 12) Everyday executive function is measured at visit 3 (month 6) and visit 5 (month 12) | — |
Countries
Germany
Contacts
Public ContactSection ClinicalTransplantation
University Hospital Schleswig-Holstein (UKSH)
Outcome results
None listed