Comparison of Safety and Efficacy of Two Variants of Prolonged - Released Tacrolimus (Advagraf vs. Envarsus ) in Patients After Liver Transplantation : Single Center Randomised Control Trial

Medical University of Warsaw200 enrolled

Overview

Adult patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after orthotropic liver transplantation (OLTx) on prolonged released Tacrolimus variant in 1:1 ratio ( Advagraf vs. Envarsus)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Liver Transplant Rejection Immunosuppression

Interventions

EnvarsusDRUG

Patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after OLTx on prolonged released Tacrolimus variant in 1:1 ratio ( Advagraf vs. Envarsus)

AdvagrafDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: adults 18- 70 after liver transplantation due to liver cirrhosis primary liver transplantation Exclusion Criteria: liver transplantation due to liver cirrhosis and hepatocellular carcinoma (HCC) retransplantation renal impairment Parkinson disease

Locations (1)

Warsaw Medical University

Warsaw, Poland

RECRUITING

Outcomes

Primary Outcomes

acute rejection

Time frame: 12 months

chronic rejection

Time frame: 5 years

tremor

Time frame: 12 months

de novo diabetes

Time frame: 5 years

Data from ClinicalTrials.gov

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