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Also known as Basiliximab, Basiliximab (Simulect)
basiliximab, MMF, cyclosporine, prednisone · 4 trials · 5 indications
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.
Treatment failure is defined as: graft loss, death, or initiation of anti-rejection therapy without prior biopsy-proven rejection (in case of medical contraindication for a biopsy).
Occurence of biopsy-proven acute rejection events at 6-months after transplantation during Period 1 (randomization to induction therapy (Campath-1H and Tacrolimus, or Basiliximab and Tacrolimus))
Estimated glomerular filtration rate (estimated using MDRD formula) at 18-months after maintenance therapy randomization to either Sirolimus or Tacrolimus.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Basiliximab | EXPERIMENTAL | Patients will be on a regimen of Basiliximab, MMF, cyclosporine and steroids |
| Basiliximab-free | ACTIVE_COMPARATOR | Patients will be on a regimen of MMF, cyclosporine and steroids. |
| Alemtuzumab/Sirolimus | EXPERIMENTAL | Induction therapy allocation: Alemtuzumab (Campath-1H). Maintenance therapy allocation (at 6-months post-transplant): Sirolimus |
| Alemtuzumab/Tacrolimus | EXPERIMENTAL | Induction therapy allocation: Alemtuzumab (Campath-1H). Maintenance therapy allocation (at 6-months post-transplant): Tacrolimus |
| Basiliximab/Tacrolimus | ACTIVE_COMPARATOR | Induction therapy allocation: Basiliximab. Maintenance therapy allocation (at 6-months post-transplant): Tacrolimus |
| Basiliximab/Sirolimus | ACTIVE_COMPARATOR | Induction therapy allocation: Basiliximab. Maintenance therapy allocation (at 6-months post-transplant): Sirolimus |
| Name | Type | Description |
|---|---|---|
| Basiliximab | DRUG | Basiliximab (10 mg) was supplied as a lyophilisate in vials with ampoules of sterile water for injection (5 mL) and had to be given of 10 mg (body weight \<35 kg) or 20 mg (body weight ≥35 kg) strength. |
| 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). |
| basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent) | DRUG | - |
| MMF, cyclosporine, steroids | DRUG | - |
| Alemtuzumab | DRUG | Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart |
| Sirolimus | DRUG | Sirolimus: target trough levels 6-12 ng/mL for first 6-months after maintenance therapy randomization, then 5-10 ng/mL |
| Tacrolimus | DRUG | Tacrolimus: target trough levels 5-7 ng/mL after maintenance therapy randomization. |
Inclusion Criteria: * Pediatric patients undergoing primary orthotopic liver transplantation (whole organ or split liver or reduced size) * Cadaveric or living donor (related or unrelated) Exclusion Criteria: * Patients who are recipients of multiple solid organ transplants and/or who have previo...
Basiliximab is used to prevent organ rejection in transplant recipients. It is studied in kidney transplantation, liver transplant, liver transplantation, and pediatric kidney transplantation. It is given as part of immunosuppressive regimens that also include mycophenolate mofetil, cyclosporine, and prednisone or an equivalent steroid.
Basiliximab targets the interleukin-2 receptor subunits IL2RA, IL2RG, and IL2RB. It acts as an inhibitor of this receptor, which is involved in T-cell activation. By binding these targets, basiliximab helps suppress the immune response that can lead to transplant rejection.
Basiliximab is developed by Novartis AG, which trades under the ticker NVS. Novartis is the company responsible for the drug's clinical development in transplant-related indications.
Basiliximab is in Phase 2 development according to the available data, with completed Phase 3 trials also reported. It is an investigational monoclonal antibody and is not described as FDA approved in the supplied information. The drug has been studied in multiple completed trials across kidney and liver transplant settings.
Basiliximab has been studied in completed trials including NCT01120028 in kidney transplantation, NCT00238901 in liver transplant, NCT00228020 in pediatric kidney transplantation, and NCT00149890 in pediatric liver transplantation. These trials enrolled a total of 852, 194, 212, and 77 participants respectively.
Yes, basiliximab is also known as Simulect. Other names associated with its treatment regimens include mycophenolate mofetil, cyclosporine, and prednisone or an equivalent steroid. Basiliximab is the active monoclonal antibody, while the other agents are companion immunosuppressants used in combination.