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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03603548

Enrollment

200

Registered

2018-07-27

Start date

2018-07-09

Completion date

2023-07-09

Last updated

2018-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunosuppression, Liver Transplant Rejection

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)

Interventions

DRUGEnvarsus

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)

DRUGAdvagraf

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
acute rejection	12 months
chronic rejection	5 years
tremor	12 months
de novo diabetes	5 years

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026