Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Basiliximab · 4 trials · 3 indications
Change in renal function was measured by change in glomerular filtration rate (GFR). GFR calculated using the abbreviated modification of diet in renal disease (aMDRD) formula. GFR in mL/min/1.73m\^2 for men of non-black ethnicity: 186 \* \[C/88\]\^-1.154 \* \[A\]\^-0.023\*G\*R ; C = serum creatinine (in μmol/L); A = Age (in years). G = 0.742 when the patient is a women; Otherwise G=1 R= 1.21 when the patient was of black ethnicity; Otherwise R = 1 Baseline was Day 28 visit.
This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.
Graft loss is defined as being listed for a re-transplantation. The analysis was based on the locally performed biopsy assessments. Generally, patients not experiencing a relevant event (i.e., acute rejection, graft loss or death) were censored with the last visit date.
| Arm | Type | Description |
|---|---|---|
| Tacrolimus | ACTIVE_COMPARATOR | From transplantation to randomization: Basiliximab (40mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids |
| Everolimus (RAD001) | EXPERIMENTAL | From transplantation to randomization: Basiliximab (40mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest). |
| Everolimus | EXPERIMENTAL | Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice |
| Calcineurin Inhibitor (CNI) | ACTIVE_COMPARATOR | Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice |
| With Intraoperative Steroids | EXPERIMENTAL | Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft. |
| Without Intraoperative Steroids | ACTIVE_COMPARATOR | No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection. |
| Name | Type | Description |
|---|---|---|
| tacrolimus | DRUG | Arm 1 : tacrolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to month 6 post-transplantation. Arm 2 : tacolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to 16 weeks post-transplantation at the latest. |
| everolimus | DRUG | Arm 1: no everolimus Arm 2: everolimus (C0 6-10 ng/ml) from randomization to month 6 post-transplantation |
| Basiliximab | DRUG | Basiliximab was supplied to the participating centers as marketed, i.e. in packs containing one vial of 20-mg powder, and water for injection (WFI). 20 mg at D0 and D4 |
| Mycophenolic Acid | DRUG | Dose of 1440 mg/day from transplantation to month 6 post- transplantation |
| Corticosteroids | DRUG | Administration of oral corticosteroid therapy was at the discretion of the centers according to their usual practice |
| CNI | DRUG | Patients who met the screening eligibility received CNI-based immunosuppressive therapy for 1 month. Then at week 4 (or week 8 at maximum), patients randomized to the CNI arm continued on CNI-based immunosuppressive therapy. |
| Cyclosporine/cyclosporine microemulsion | DRUG | Cyclosporine/cyclosporine microemulsion had to be started with 100 mg/m²/day intravenous (i.v) (2x4h) for 7 days and was to be continued i.v. or orally from day 8 onwards as per center practice. During the 6 months treatment period Cyclosporine doses had to be adjusted according to Cyclosporine A (CsA)-trough levels. |
| Steroid | DRUG | Intravenous prednisolone (loading dose: 300 mg/m2, maximum 500 mg) had to be administered intraoperatively only in treatment arm 1 (day 0). The first dose of steroids in treatment arm 2 (day 0) had to be administered within 8 hours after reperfusion of the graft. Beginning from day 1 to day 6 doses of 15 mg/m2/day had to be given intravenously (i.v.) in both treatment arms. Then, the steroid doses (oral prednisone or its equivalent) were to be decreased from 10 mg/m²/day orally (day 7-13), to 7.5 mg/m²/day orally (day 14-30), to 4 mg/m²/day orally (until end of month 2), to 2.5 mg/m²/day orally (until end of month 3) and to 1 mg/m²/day orally (until end of month 6). |
Key Inclusion Criteria: * Man or woman aged 18 years or greater, recipient of a primary liver transplant from a deceased donor with whole or split liver Key Exclusion Criteria: * Patient recipient of multiple solid organ or islet cell tissue transplants, or have previously received an organ or ti...
Basiliximab is used in liver transplantation to prevent organ rejection. It is an investigational small molecule being studied in Phase 3 clinical trials for patients undergoing liver transplants, including pediatric and adult recipients. The drug is evaluated for its efficacy and safety in combination with other immunosuppressive therapies.
Basiliximab targets the interleukin-2 receptor alpha chain, also known as CD25, on activated T lymphocytes. By binding to this receptor, it inhibits interleukin-2-mediated T cell activation, which is a key pathway in the immune response that leads to organ rejection after transplantation.
Basiliximab is developed by Novartis AG, a multinational pharmaceutical company. Novartis is publicly traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's use in liver transplant patients.
Basiliximab is in Phase 3 clinical development for liver transplantation. It is an investigational drug and has not been approved by regulatory authorities for this indication. The Phase 3 trials have been completed, and the drug is not currently in active clinical trials.
Basiliximab has been studied in three completed Phase 3 clinical trials for liver transplantation. These include NCT00149890 in pediatric de novo liver transplant recipients, NCT00238901 in hepatitis C virus positive patients, and NCT00378014 for preservation of renal function in liver transplant recipients.
Basiliximab is also known by the brand name Simulect. It is a monoclonal antibody that targets the interleukin-2 receptor alpha chain. In the context of liver transplantation, it is being studied as an immunosuppressive agent to prevent acute organ rejection.