The Establishment of Multiple Point Prediction Model About Tacrolimus Metabolic Differences Based on Genetic Network After Liver Transplantation and the Application of Multicenter

Shanghai Jiao Tong University

Status: Unknown

Conditions: Cirrhosis, Liver

Treatments: Drug: Tacrolimus（FK506）

Study type: Interventional

Funder types: Other

Identifiers

NCT02752529

PZhihai

Details and patient eligibility

About

Combined with the clinical data of FK506 and the database of GO and Kyoto Encyclopedia of Genes and Genomes（KEGG）, the investigators aim to carry out the bioinformatic analysis and build a muti-locus genetic model, then muti-center assess the predictive accuracy of FK506 metabolic differences.

Enrollment: 415 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of end-tage liver diseases
• 18 years old or above
• Han nationality
• Therapeutic regimen：TAC

Exclusion criteria

• Less than 18 years old
• Other races
• Therapeutic regimen：cyclosporine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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415 participants in 2 patient groups

Tacrolimus/dose1

Experimental group

Description:

Tacrolimus 5mg tablet and dosage based on Co once/twice a day for 7 days

Treatment:

Drug: Tacrolimus（FK506）

Tacrolimus/dose2

Active Comparator group

Description:

Tacrolimus 5mg tablet and dosage based on Co once/twice a day for 7 days

Treatment:

Drug: Tacrolimus（FK506）