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

NCT03603548 — Not applicable, Unknown, 200 participants, Medical University of Warsaw

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Registry	NCT03603548
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, single group, masking: none, treatment
Enrollment	200 (Estimated)
Sponsor	Medical University of Warsaw (Other)
Conditions	Liver Transplant Rejection, Immunosuppression
Interventions	Envarsus, Advagraf (Drug)
Dates	start 2018-07-09, primary completion 2023-07-09 (estimated), completion 2023-07-09 (estimated), first posted 2018-07-27, last updated 2018-07-27
Locations	1 site in Poland

-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)

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+Arms and interventions

Arm	Type	Interventions	Description
Advagraf	Active comparator	Drug: Advagraf
Envarsus	Experimental	Drug: Envarsus

Envarsus (Drug): 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)
Advagraf (Drug): 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)

+Outcome measures

Primary outcomes

acute rejection [12 months]
chronic rejection [5 years]
tremor [12 months]
de novo diabetes [5 years]

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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)

Facility	City	Country	Status
Warsaw Medical University	Warsaw	Poland	Recruiting

My Notes

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