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

NCT ID: NCT03603548

Last Updated: 2018-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-09

Study Completion Date

2023-07-09

Brief Summary

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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

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Conditions

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Liver Transplant Rejection Immunosuppression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Advagraf

Group Type ACTIVE_COMPARATOR

Advagraf

Intervention Type 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)

Envarsus

Group Type EXPERIMENTAL

Envarsus

Intervention Type 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)

Interventions

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Envarsus

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)

Intervention Type DRUG

Advagraf

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)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Warsaw Medical University

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Facility Contacts

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Magdalena Arłukowicz- Grabowska, MD

Role: primary

00 48 599 1662

Other Identifiers

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WarsawMUAdvEnv

Identifier Type: -

Identifier Source: org_study_id

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