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 Warsaw

Status: Unknown

Conditions: Liver Transplant Rejection; Immunosuppression

Treatments: Drug: Advagraf; Drug: Envarsus

Study type: Interventional

Funder types: Other

Identifiers

NCT03603548

WarsawMUAdvEnv

Details and patient eligibility

About

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)

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Advagraf

Active Comparator group

Treatment:

Drug: Advagraf

Envarsus

Experimental group

Treatment:

Drug: Envarsus