Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Simulect ® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED), and corticosteroids. The efficacy of Simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated. FDA label
Also known as Basiliximab, Basiliximab (Simulect)
Simulect · 5 trials · 6 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).
CD25 saturation is the percentage of T cells expressing CD25. Mean AUC of CD25 was calculated only for patients who received two Simulect® injections.
CD25 saturation is the percentage of T cells expressing CD25
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. |
| Simulect 40mg + Neoral + Myfortic + steroids | ACTIVE_COMPARATOR | A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids |
| Simulect 80mg + Neoral + Myfortic + steroids | EXPERIMENTAL | A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids |
| Simulect 80mg + Certican + Myfortic + steroids | EXPERIMENTAL | A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids |
| 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 | - |
| Simulect® | DRUG | Simulect® was provided to the study center in its commercial package containing a powder vial with 20 mg of active product and sterile water for injection. The solution should be used immediately after reconstitution. The infusion was prepared by adding at least 50 mL of physiologic or 5% glucose solution to the reconstituted solution (at least 100 mL for 40 mg of Simulect®). Simulect® was transported and kept in a cold environment (2-8°C) as recommended in the summary of product characteristics (SPC). |
| Neoral® | DRUG | Neoral® was provided to the study center in its commercial package as 10, 25, 50 or 100 mg soft capsules in thermoformed blister packs. |
| Certican® | DRUG | Certican® was provided to the study center in its commercial package as 0.75, 0.5 and 0.25 mg tablets in thermoformed blister packs. |
| Myfortic® | DRUG | Myfortic® was administered orally b.i.d. with a 12-hour interval. Tablets could be taken either with or outside meals but consistently throughout the study. To maintain the integrity of the enteric coating, tablets were not to be crushed. Myfortic® treatment was initiated either preoperatively or within 24 hours post transplantation according to local practice in each center. Starting dose was to be 2160 mg/day (1080 mg b.i.d.) for at least 2 weeks and for at most 4 weeks. Patients were then to receive 1440 mg/day (720 mg b.i.d.) until the end of the study. Myfortic® was administered as concomitant treatment to all patients, using the same regimen for all 3 study groups. It was provided to the study center in its commercial package as 180 and 360 mg gastro-resistant tablets. |
| Corticosteroids | DRUG | Corticosteroid i.v. therapy could be administered peri or per operatively according to local practice in each center with the same scheme for each patient in the center. Oral corticotherapy was to be initiated rapidly, within one week following transplantation, with a minimal dose of 20 mg/day. Thereafter, the dose was to be decreased according to local practice but oral corticosteroids were to be continued throughout the study with a minimal dose of 5 mg/day. |
| 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...
Simulect is used in renal transplantation. It is studied in adult low risk de novo renal transplant recipients, where it is given in combination with ciclosporine microemulsion or everolimus. Its therapeutic area is nephrology, and the recorded development stage is Phase 2.
Simulect is developed by Novartis AG, which trades under the ticker NVS. The company is the sponsor associated with the clinical development of the drug in renal transplantation.
Simulect is in Phase 2 development. It is an investigational agent in the recorded clinical program rather than a marketed product, and the single listed trial has been completed. No active trials are currently recorded for it.
Simulect has been studied in one recorded clinical trial, NCT01596062, also called the IDEALE Study. It was a Phase 2, randomized, active controlled trial of basiliximab 40 or 80 mg with ciclosporine microemulsion or everolimus in adult low risk de novo renal transplant recipients in France, and it enrolled 16 participants.
Yes, Simulect is the brand name for basiliximab, and it is also written as Simulect®. Searches for either name refer to the same agent, which is being studied in renal transplantation in combination with ciclosporine microemulsion or everolimus.