Status:
ACTIVE_NOT_RECRUITING
Bioavailability and Practicability of Envarsus Versus Advagraf in Liver Transplant Recipients
Lead Sponsor:
Edward Geissler
Collaborating Sponsors:
Chiesi Pharmaceuticals GmbH
Excelya
Conditions:
Prophylaxis Against Liver Transplant Rejection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Trial participants are randomised within 14 days after liver transplantation surgery in a 1:1 ratio to two alternative treatment arms containing either Envarsus® (test arm) or Advagraf® (comparator ar...
Eligibility Criteria
Inclusion
- Signed and dated written informed consent
- Adult (≥18 years old) male or female
- Recipient of a whole liver transplant from a deceased donor or a split liver transplant from a deceased or living donor
- ABO blood type compatible with the organ donor
- Able to swallow an oral formulation of tacrolimus in tablet or capsule form
Exclusion
- Multi-organ transplantation
- Any previous organ allograft transplantation
- Biopsy-proven acute rejection that is ongoing at the time of randomisation
- Occurrence of post-transplant thrombosis, occlusion or stent placement in any major hepatic arteries, hepatic veins, portal vein or inferior vena cava
- History of extra-hepatic malignancy that could not be curatively treated
- Hepatocellular carcinoma with extra-hepatic spread or macrovascular invasion
- Uncontrolled systemic infection
- Requirement of life support measures such as ventilation or vasopressor agents (\>20 µg/kg body weight/h) at the time of randomisation
- Known contraindication or hypersensitivity to tacrolimus, and/or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics of both Envarsus® and Advagraf®, and/or to any other macrolides
- Ongoing, planned or foreseeable use of cyclosporine or any tacrolimus preparation other than Envarsus® or Advagraf® (except for immediate-release formulations administered before randomisation)
- Any prolonged-release tacrolimus treatment prior to randomisation
- Pregnant or nursing (lactating) female, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test
- Female of child-bearing potential, defined as physiologically capable of becoming pregnant, unless using a reliable method of contraception
- Participation in another interventional clinical trial during the time period from randomisation to study end, if the trial is testing an Investigational Medicinal Product or if the intervention and/or follow-up requirements of the trial impede or interfere with either the objectives of EnGraft or the treatment / follow-up requirements of EnGraft
- Any condition or factor which, in the judgement of the investigator, would place the subject at undue risk, invalidate communication with the investigator or study team, or hamper compliance with the trial protocol or follow-up schedule
- Inability to freely give informed consent (e.g. individuals under legal guardianship)
Key Trial Info
Start Date :
December 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2026
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT04720326
Start Date
December 23 2020
End Date
October 1 2026
Last Update
April 6 2025
Active Locations (15)
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1
University Hospital Aachen
Aachen, Germany, 52074
2
Charite - University Medicine Berlin
Berlin, Germany, 13353
3
University Hospital Essen
Essen, Germany, 45147
4
University Hospital Frankfurt
Frankfurt, Germany, 60590