Study on the Effects of Tacrolimus and Mycophenolate Mofetil in Patients After Liver Transplantation

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What is this study about?

This clinical trial is focused on studying the effects of certain medications in patients who have undergone a liver transplantation. The medications being tested are Envarsus, Advagraf, and CellCept. These drugs are known as immunosuppressants, which help prevent the body from rejecting the new liver. The study aims to evaluate the benefits of taking these medications as a single daily dose over the first year after the transplant.

The trial will compare two different forms of the drug tacrolimus, which are Envarsus and Advagraf, to see if they are equally effective in preventing treatment failure. Treatment failure is defined as any of the following events: patient death, loss of the transplanted liver, or acute rejection of the liver, which is confirmed by a biopsy. The study will also compare the effects of taking CellCept once a day versus twice a day.

Participants in the study will be monitored for up to 18 months after their liver transplant. The study will look at various outcomes, including the proportion of deaths, loss of the transplanted liver, and cases of acute rejection. It will also assess the quality of life and any side effects experienced by the participants. The goal is to determine the most effective and safe way to administer these immunosuppressive drugs to liver transplant recipients.

1 joining the study

Upon joining the study, the patient will be enrolled as a liver transplant recipient. The study focuses on evaluating the benefits of administering immunosuppressive drugs as single daily doses over the first year after transplantation.

2 initial medication administration

The patient will begin taking Envarsus and Advagraf, which are forms of tacrolimus, a medication used to prevent organ rejection. These are prolonged-release tablets and capsules taken orally once daily.

The patient will also take CellCept, which contains mycophenolate mofetil, another medication to prevent rejection. This is available in film-coated tablets and capsules, also taken orally.

3 medication dosage and frequency

The specific dosage of Envarsus and Advagraf will vary, with available strengths including 0.5 mg, 0.75 mg, 1 mg, 3 mg, and 5 mg for Advagraf, and 0.75 mg, 1 mg, and 4 mg for Envarsus.

For CellCept, the available strengths are 250 mg and 500 mg. The frequency of administration is once daily for all medications.

4 monitoring and evaluation

Throughout the study, the patient will be monitored for treatment effectiveness and any potential side effects. The primary focus is on preventing treatment failure, which includes patient death, graft loss, or acute rejection.

The study will compare the effectiveness of different dosing strategies, including once daily (QD) versus twice daily (BID) administration of mycophenolate mofetil.

5 study duration

The study will last for 18 months post-transplantation, with evaluations at 6 months and 18 months to assess the outcomes of the treatment strategies.

Who Can Join the Study?

Male and female patients, aged 18 and older.
Recipients of a first liver allograft from a deceased donor. An allograft is a transplanted organ or tissue from a donor.
Transplanted for less than four weeks at enrollment.
Without any current progressive life-threatening or graft-threatening disease. This means the patient should not have any serious illness that could endanger their life or the transplanted organ.
Having signed a written informed consent for their participation in the study. This means the patient agrees to join the study after understanding all the details.
Affiliated to, or beneficiary of, a social security regimen. This means the patient should be part of a social security system or have similar benefits.

Who Cannot Join the Study?

Patients who have not received a liver transplant.
Patients who are younger than 18 years old.
Patients who are older than 65 years old.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hopital Beaujon	Clichy	France
Hospital Paul Brousse	Villejuif	France
Hôpital Pontchaillou-CHU Rennes	Rennes	France
Cqhouc Hldhvjuonli El Uyjqvpgcrhodh Dq Lvsxajd	Limoges	France
Cduuha Hsvczaqhibl Umpjjnqhoytow Dr Dfzvs	Dijon	France
Aflptrnigp Psppfxjm Hwircrff Dg Mlgpddxpe	Marseille	France
Btarqgds Uaogngkgkv Hiumqlia Cyrbrc	Besançon	France
Cptkbr Hqbkjbemuke Rdudrflo Uypvxqageownd Da Twpet	Tours	France
Ced Ctnsx Rkvrpybdqwl	Lyon	France
Hjkuezlp Unheilpyxvkkdu Sizudcpnkc &jgfunc Hsktdya dd Hsztxktoogc	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	02.09.2024

Trial locations

Investigated drugs:

ENVARSUS® is a medication used in liver transplant patients to help prevent the body from rejecting the new liver. It is an immunosuppressive drug, which means it works by suppressing the immune system to prevent it from attacking the transplanted organ. In this trial, it is being evaluated to see if it can be effectively administered once daily.

MMF (Mycophenolate Mofetil) is another immunosuppressive medication used to prevent organ rejection in liver transplant patients. It is being studied to determine if taking it once daily is as effective as taking it twice daily in preventing treatment failure.

ADVAGRAF® is an extended-release form of tacrolimus, another immunosuppressive drug used in liver transplant patients. This trial is comparing its effectiveness when taken once daily to that of ENVARSUS® to see if they are equivalent in preventing treatment failure.

Investigated diseases:

Liver transplant

Liver Transplantation – Liver transplantation is a surgical procedure that involves replacing a diseased liver with a healthy liver from a donor. This procedure is typically considered when the liver no longer functions properly due to conditions such as cirrhosis, liver cancer, or acute liver failure. After the transplant, the recipient’s body may recognize the new liver as foreign and attempt to reject it, which is why immunosuppressive medications are necessary to prevent rejection. Over time, the body may adapt to the new liver, but ongoing monitoring and medication adjustments are often required. The success of the transplant can be influenced by factors such as the recipient’s overall health, the condition of the donor liver, and adherence to medical advice.

Trial ID:

2023-506601-19-00

Protocol code:

87RI23_0031

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Tacrolimus and Mycophenolate Mofetil in Patients After Liver Transplantation

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