TACROLIMUS for Liver transplantation

Inclusion criteria

• {"criterion_text":"- 1.\tMale and female patients, aged 18 and older\n- 2.\tRecipients of a first liver allograft from a deceased donor\n- 3.\tTransplanted for less than four weeks at enrolment\n- 4.\tWithout inter-current progressive life-threatening or graft-threatening disease\n- 5.\tHaving signed a written informed consent for their participation in the study.\n- 6.\tAffiliated to, or beneficiary of, a social security regimen"}

Exclusion criteria

• {"criterion_text":"- 1.\tRecipients of a split-liver transplantation\n- 9.\tWomen of childbearing potential without any effective contraceptive method (according to the guidelines of CTFG, Clinical Trial Facilitation Group, related to contraception and pregnancy test in clinical trials) or not practicing sexual abstinence during treatment by CELLCEPT and for 6 weeks after the end of CELLCEPT administration\n- 10.\tSexually active men or their female partner without any effective contraception during treatment by CELLCEPT and for at least 90 days after the end of CELLCEPT administration\n- 6.\tPatients treated with HIV or HCV protease inhibitors\n- 11.\tPatients incapable of understanding the purposes and risks of the study, who cannot give written informed consent, or who are unwilling to comply with the study protocol.\n- 12.\tPatients already enrolled in another clinical study evaluating drugs or therapeutic strategies.\n- 2.\tRecipients of any transplanted organ other than the liver\n- 3.\tPatient who has undergone colon resection\n- 4.\tPatients under legal protection (guardianship, curatorship)\n- 5.\tPatient presenting any contra-indication to tacrolimus or to MMF according to the summary of product characteristics (SmPC) of ENVARSUS®, ADVAGRAF® and CELLCEPT®.\n- 7.\tPatients in whom everolimus-based CNI minimization is anticipated\n- 8.\tPregnant or lactating women without efficient contraceptive method (based on declaration)"}

Primary endpoints

• {"endpoint_text":"- The primary outcome will be a composite endpoint, named “treatment failure”, defined by the occurrence of any of the following events during the first 6 months (2nd objective) or during the first 18 months (1st objective) after transplantation: • Patient death, • Graft loss, • Biopsy-proven acute rejection, with a rejection activity index score ≥4 according to the Banff criteria","definition_or_measurement_approach":"Composite endpoint 'treatment failure' defined as occurrence of any of: patient death; graft loss; biopsy-proven acute rejection with rejection activity index score ≥4 according to Banff criteria. Measured as incidence within first 6 months (for 2nd objective) and within first 18 months (for 1st objective) after transplantation."}

Secondary endpoints

• {"endpoint_text":"- Comparison, between patients on XR-tacrolimus and patients on LCP-tacrolimus, at M18 post-transplantation a. The proportion of deaths b. The proportion of graft losses c. The proportion of biopsy-proven acute rejection with an activity score ≥4\n- Comparison, between patients the four arms, at M6 andM18 post-transplantation, of: a. The proportion of deaths b. The proportion of graft losses c. The proportion of biopsy-proven acute rejection with an activity score ≥4\n- Comparison, between patients on XR-tacrolimus and patients on LCP-tacrolimus, at M18 post-transplantation, of: a. The proportion of non-adherent patients b. Mean PCS-QOL and MCS-QOL\n- Comparison, between patients on XR-tacrolimus and patients on LCP-tacrolimus, at M18 post-transplantation, of the incidence of adverse events of interest\n- Comparison, between patients on MMF BID and patients on MMF QD , at M18 post-transplantation, of: a.\tThe proportion of non-adherent patients b.\tMean PCS-QOL and MCS-QOL c.\tThe incidence of adverse events of interest\n- Comparison, between the four arms and at each post-transplantation period, of: a. Mean tacrolimus and MPA AUC0-24h, b. Mean tacrolimus C0/dose and AUC0-24h/dose, c. Mean MPA AUC0-24h/dose.","definition_or_measurement_approach":"Secondary endpoints are comparative proportions, incidences and pharmacokinetic measures assessed at month 6 and month 18 (M6, M18) post-transplantation. Includes proportions of death, graft loss, biopsy-proven acute rejection (activity score ≥4), adherence measures (non-adherent proportion), QOL scores (PCS-QOL, MCS-QOL), incidence of predefined adverse events, and PK parameters (AUC0-24h, C0/dose, AUC0-24h/dose for tacrolimus and MPA)."}

France

Earliest CTIS Part Ii Submission Date

02-05-2024

Latest Decision Or Authorization Date

09-04-2026

Processing Time Days

707

Number Of Sites

18

Number Of Participants

200

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Limoges

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"TRAJAN SCIENTIFIC AND MEDICAL","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"CHIESI","duties_or_roles":"Source of monetary support","organisation_type":""}