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Study Comparing Tacrolimus Formulations for Preventing Liver Transplant Rejection in New Adult Recipients

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What is this study about?

This clinical trial is focused on studying the effectiveness of two medications, Envarsus and Advagraf, in patients who have recently received a liver transplant. The main goal is to see how well these medications work in preventing the body from rejecting the new liver. Both medications contain the active ingredient tacrolimus, which is used to suppress the immune system and help the body accept the transplanted organ. The study will compare the two medications to determine which one is more effective in maintaining the right levels of the drug in the body over time.

Participants in the study will be randomly assigned to receive either Envarsus or Advagraf after their liver transplant. The study will last for up to three years, with regular check-ups to monitor the levels of the medication in the blood and assess the health of the liver. The study will also track any side effects or complications that may arise during the treatment period. The aim is to find out which medication provides better control of drug levels, which can help improve the overall success of the liver transplant.

Throughout the study, participants will take their assigned medication once daily in the form of a prolonged-release tablet or capsule. This means the medication is designed to release slowly into the body over time, helping to maintain a steady level of the drug. The study will also look at how practical and easy it is for patients to take these medications as part of their daily routine. By comparing the two medications, researchers hope to provide valuable information that can help improve treatment options for liver transplant patients in the future.

1 joining the study

Upon joining the study, the patient must provide signed and dated written informed consent.

The patient must be an adult, 18 years or older, and have received a liver transplant from a compatible donor.

The patient must be able to swallow oral formulations of the medication.

2 medication administration

The patient will be randomly assigned to receive either Envarsus or Advagraf, both of which are forms of the medication tacrolimus.

Envarsus is available in 0.75 mg, 1 mg, and 4 mg prolonged-release tablets, while Advagraf is available in 0.5 mg, 1 mg, 3 mg, and 5 mg prolonged-release capsules.

The medication is taken orally once daily.

3 monitoring and adjustments

The patient’s medication dosage may be adjusted based on the concentration of the drug in the blood, known as the C/D ratio (concentration/dose ratio).

This ratio is measured at 12 weeks and may also be assessed at 1, 2, and 3 years.

The number of dose adjustments and the time to reach the target drug level will be recorded.

4 follow-up assessments

The patient will undergo regular assessments to monitor liver function, metabolic profile, and renal function at 12 weeks and at 1, 2, and 3 years.

The incidence of any adverse events, such as infections or new health conditions, will be documented.

The study will also track the occurrence of any rejection episodes, graft failure, or other complications.

5 study completion

The study is expected to conclude by December 31, 2026.

The patient’s participation will be evaluated based on the continuation rate and any reasons for withdrawal from the study.

Who Can Join the Study?

  • Must provide a signed and dated written informed consent, which means you agree to participate in the study after being informed about it.
  • Must be an adult, which means you are 18 years old or older.
  • Must have received a whole liver transplant from a deceased donor or a split liver transplant from either a deceased or living donor.
  • Must have an ABO blood type that is compatible with the organ donor. This means your blood type must match with the donor’s blood type.
  • Must be able to swallow tacrolimus, which is a medication, in the form of a tablet or capsule.

Who Cannot Join the Study?

  • Patients who are not adults cannot participate. This means only individuals who are 18 years or older are eligible.
  • Patients who have not received a liver transplant are excluded. The study is for those who have had a liver transplant.
  • Patients who are not taking tacrolimus, a medication used to prevent organ rejection, are excluded. The study involves comparing two forms of this medication.
  • Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Hochschule Hannover Hanover Germany
University Hospital Jena KöR Jena Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Universitaet Leipzig Leipzig Germany

Other Sites

Site Name City Country Status
Universitaetsklinikum Aachen AöR Aachen Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
Uqiwcqzifx Mkvkglc Cwrucc Hnyjjhxtrczbpkeoz Hamburg Germany
Uvcnvhxectsdtaiolaepf Eofby Aox Essen Germany
Ujgmezexaddieosblqcfy Mkklckyl Afx Munster Germany
Gycqms Uzaqaanrlf Fhrcwquxi Frankfurt Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.12.2020

Trial locations

Investigated drugs:

Envarsus is a medication used to help prevent the body from rejecting a new liver after a transplant. It is a once-daily formulation of tacrolimus, which is an immunosuppressant. This means it helps to lower the body’s immune response to prevent it from attacking the new liver.

Advagraf is another once-daily formulation of tacrolimus, similar to Envarsus. It is also used to prevent organ rejection in liver transplant patients by suppressing the immune system. The study aims to compare the effectiveness and practicality of Envarsus and Advagraf in new liver transplant recipients.

Transplant Rejection – Transplant rejection occurs when the recipient’s immune system identifies the transplanted organ as foreign and attacks it. This immune response can lead to inflammation and damage to the transplanted organ. Rejection can be acute, happening shortly after the transplant, or chronic, developing over a longer period. Symptoms may include fever, pain at the transplant site, and changes in organ function. The severity and progression of rejection can vary, potentially affecting the long-term success of the transplant. Monitoring and managing the immune response is crucial to prevent or minimize rejection.

Trial ID:
2024-518033-28-00
Protocol code:
EnGraft
NCT ID:
NCT04720326
Trial Phase:
Therapeutic confirmatory (Phase III)

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