A study to compare the bioavailability and practicability of two immunosuppressive drugs (Envarsus® and Advagraf®) containing the same active substance used to prevent graft rejection in patients who have received a liver transplant for the first time.

Phase 1

• Conditions: Prophylaxis of transplant rejection in adult liver allograft recipients; MedDRA version: 21.1Level: LLTClassification code 10050434Term: Prophylaxis against liver transplant rejectionSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2020-000796-20-DE
• Lead Sponsor: niversity Hospital Regensburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-04
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 268

Inclusion Criteria

1. Signed and dated written informed consent
2. Adult ( = 18 years old) male or female
3. Recipient of a whole liver transplant from a deceased donor or a split liver transplant from a deceased or living donor
4. ABO blood type compatible with the organ donor
5. Able to swallow an oral formulation of tacrolimus (tablet / capsule)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 268
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 268

Exclusion Criteria

1. Multi-organ transplantation
2. Any previous organ allograft transplantation
3. Biopsy-proven acute rejection that is ongoing at the time of randomisation
4. Occurrence of post-transplant thrombosis, occlusion or stent placement in any major hepatic arteries, hepatic veins, portal vein or inferior vena cava
5. History of extra-hepatic malignancy that could not be curatively treated
6. Hepatocellular carcinoma with extra-hepatic spread or macrovascular invasion
7. Uncontrolled systemic infection
8. Requirement of life support measures such as ventilation or vasopressor agents (>20 µg/kg BW/h) at the time of randomisation
9. Known contraindication or hypersensitivity to tacrolimus, and/or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics (SmPC) of both Envarsus® and Advagraf®, and/or to any other macrolides
10. Ongoing, planned or foreseeable use of cyclosporine or any tacrolimus preparation other than Envarsus® or Advagraf® (except for immediate-release formulations administered before randomisation)
11. Any prolonged-release tacrolimus treatment prior to randomisation
12. Participation in another interventional clinical trial during the time period from randomisation to study end, if the trial is testing an IMP (AMG study) 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified