Cognitive function after liver transplantation comparing Tacrolimus formulations

Conditions

ICD 10: Z94.4 Liver transplant status

Brief summary

Change in subjective impression of QoL concerning attention/concentration and memory between Screening and visit 3 (6 months) using the FEDA (self-report questionnaire on attention and memory)

Detailed description

Cognitive function is assessed using (I) the Trail Making Test – TMT (time criterion), (II) Adaptive Digit Ordering Test – DOT-A (number of correctly sorted digits), (III) Digit Symbol Test – DST (number of correctly sorted items), (IV) Regensburg Stream of Speech Test – RWT (number of correct items), (V) Victoria Stroop Test – VST (time criterion), Quality of life (QoL) is measured using the SF36 (summary score). QoL will be performed during Screening, after 6 and after 12 months., Everyday executive function is measured by BAFQ (assessment by close relative/partner or care provider). BAFQ will be performed during Screening, after 6 and after 12 months., All (serious) adverse events including clinically significant laboratory parameters and relevant liver and kidney functioning parameters are documented at each visit after baseline.

Related papers

No related papers found yet.

Interventions

DRUGPrograf 0

DRUG5 mg Hartkapseln

DRUGPrograf 1 mg Hartkapseln

DRUGEnvarsus 0.75 mg prolonged-release tablets

DRUGPrograf 5 mg Hartkapseln

DRUGEnvarsus 1 mg prolonged-release tablets

DRUGEnvarsus 4 mg prolonged-release tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in subjective impression of QoL concerning attention/concentration and memory between Screening and visit 3 (6 months) using the FEDA (self-report questionnaire on attention and memory)	—

Secondary

Measure	Time frame
Cognitive function is assessed using (I) the Trail Making Test – TMT (time criterion), (II) Adaptive Digit Ordering Test – DOT-A (number of correctly sorted digits), (III) Digit Symbol Test – DST (number of correctly sorted items), (IV) Regensburg Stream of Speech Test – RWT (number of correct items), (V) Victoria Stroop Test – VST (time criterion), Quality of life (QoL) is measured using the SF36 (summary score). QoL will be performed during Screening, after 6 and after 12 months., Everyday executive function is measured by BAFQ (assessment by close relative/partner or care provider). BAFQ will be performed during Screening, after 6 and after 12 months., All (serious) adverse events including clinically significant laboratory parameters and relevant liver and kidney functioning parameters are documented at each visit after baseline.	—

Measure

Time frame

Cognitive function is assessed using (I) the Trail Making Test – TMT (time criterion), (II) Adaptive Digit Ordering Test – DOT-A (number of correctly sorted digits), (III) Digit Symbol Test – DST (number of correctly sorted items), (IV) Regensburg Stream of Speech Test – RWT (number of correct items), (V) Victoria Stroop Test – VST (time criterion), Quality of life (QoL) is measured using the SF36 (summary score). QoL will be performed during Screening, after 6 and after 12 months., Everyday executive function is measured by BAFQ (assessment by close relative/partner or care provider). BAFQ will be performed during Screening, after 6 and after 12 months., All (serious) adverse events including clinically significant laboratory parameters and relevant liver and kidney functioning parameters are documented at each visit after baseline.

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Countries

Germany

Outcome results

None listed