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

Not Applicable

• Conditions: Immunosuppression; Liver Transplant Rejection
• Interventions: Drug: Envarsus; Drug: Advagraf

• Registration Number: NCT03603548
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-07
• Study Start: 2018-07-09
• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-07-19
• Last Update Submitted: 2018-07-19
• Study First Posted: 2018-07-27
• Last Update Posted: 2018-07-27
• Primary Completion: 2023-07-09
• Study Completion: 2023-07-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Envarsus	Envarsus	-
Advagraf	Advagraf	-

Primary Outcome Measures

Name	Time	Method
acute rejection	12 months
chronic rejection	5 years
tremor	12 months
de novo diabetes	5 years

Trial Locations

Locations (1)

Warsaw Medical University; 🇵🇱 Warsaw, Poland