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Minimisation of TAC · 1 trial · 1 indication
Clinical benefit is defined as: • an improvement in 1 or 2 ranges of the eGFR, according to MDRD-4 at Week 52 post-transplant in patients with values of 30-\<45 or 45-\<60 mL/min/1.73 m2 in Week 4. or • stabilisation of eGFR in patients with values ≥60 mL/min/1.73 m2 at Week 4 and maintained at Week 52 post-transplant.
| Arm | Type | Description |
|---|---|---|
| Minimisation of TAC | EXPERIMENTAL | Treatment with rTAC+EVR+corticosteroids |
| TAC + MMF + corticosteroids | ACTIVE_COMPARATOR | Treatment with TAC + MMF + corticosteroids |
| Name | Type | Description |
|---|---|---|
| Minimisation of TAC | DRUG | •EVR: Treatment started at a total daily dose of 2 mg within 24 hours after randomisation. The dose of EVR was adjusted upon reaching trough levels (C-0h) in whole blood of 3-8 ng/mL. The daily dose (in two administrations) of EVR may have been modified to maintain trough levels (C-0h) in whole blood of 3-8 ng/mL until Week 52 post-transplant. •TAC: Once confirmation was obtained, beginning in Week 5, that trough levels (C-0h) in whole blood of EVR were between 3-8 ng/mL, minimisation of TAC began, in order to reach trough levels (C-0h) of TAC in whole blood of ≤5 ng/mL no later than four weeks after randomisation (Week 8), which were levels that should have been maintained until Week 52 post-transplant. •MMF was withdrawn at the same time that EVR was introduced. •oral corticosteroids was administered in accordance with local clinical practice, although a therapeutic strategy free of corticosteroids was permitted |
| TAC + MMF + corticosteroids | DRUG | •Dose of TAC: Trough levels (C-0h) of TAC in whole blood should have been maintained between 6-10 ng/mL until Week 52 post-transplant. •Dose of MMF: Doses of 500-1000 mg/12 hrs was maintained until Week 52. •Corticosteroids: During the study, oral corticosteroids was administered in accordance with local clinical practice, although a therapeutic strategy free of corticosteroids was permitted (e.g. in patients with a history of HCV). It was recommended in any case that corticosteroids not be administered beyond Week 24 post-transplant except in cases of hepatopathy of autoimmune origin. At each centre all patients should have followed the same administration protocol for corticosteroids based on history of HCV. |
Screening Visit - Inclusion Criteria 1. Recipients age 18 or over receiving a first liver transplant from a cadaver donor. 2. Patients diagnosed with HCC must meet the Milan radiological criteria at the time of transplant (1 nodule ≤5 cm in diameter, or 2-3 nodules, all \<3 cm in diameter) - at tim...
Minimisation of TAC is an investigational immunosuppression regimen being studied for use in liver transplant recipients. It involves minimizing tacrolimus exposure while combining it with everolimus, with the goal of assessing the impact on renal function in de novo liver transplant patients over a 12-month follow-up period.
Minimisation of TAC is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate this immunosuppression approach in liver transplant patients.
Minimisation of TAC is in Phase 3 clinical development. It is an investigational regimen that has not been approved by regulatory authorities, and it remains under evaluation in clinical trials to determine its safety and efficacy in liver transplant recipients.
Minimisation of TAC is being evaluated in clinical trial NCT02040584, a Phase 3, multicenter, randomized, open-label, active-controlled study with 12-month follow-up. The trial enrolled 217 participants in Spain and has been completed, assessing an immunosuppression regimen based on tacrolimus minimization combined with everolimus in de novo liver transplant recipients.
Yes, the clinical trial for Minimisation of TAC, NCT02040584, is a randomized, active-controlled study. It is open-label, meaning both researchers and participants know which treatment is being administered, and it is not double-blinded. The study enrolled 217 adult participants of all sexes, aged 18 years and older.