Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Everolimus 0.25 · 1 trial · 1 indication
A graft core biopsy was performed on all suspected acute rejection episodes within 48 hours. Biopsies were read by the local pathologist according to the 1997 Banff criteria. A biopsy-proven acute rejection was be defined as a biopsy graded IA, IB, IIA, IIB, or III.
Renal function was assessed by measuring serum creatinine and by computing creatinine clearance using the formula of Cockcroft-Gault.
| Arm | Type | Description |
|---|---|---|
| Upper everolimus blood target + very low dose cyclosporine | EXPERIMENTAL | Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study. |
| Standard everolimus blood target + low dose cyclosporine | ACTIVE_COMPARATOR | Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study. |
| Name | Type | Description |
|---|---|---|
| Everolimus 0.25 and 0.75 mg tablets | DRUG | The dose of everolimus for each patient was adjusted to achieve the target everolimus blood level range. Everolimus blood trough level was measured 5 days after any dose adjustment to verify that the blood level was within the desired target level range. |
| Cyclosporine very low dose (150-300 ng/mL) microemulsion | DRUG | The dose of cyclosporine for each patient was adjusted to achieve the target cyclosporine blood level. Cyclosporine dose adjustments were based on drug blood level determined from whole blood samples taken 2 hours (± 10 min) after the morning dose. |
| Cyclosporine low dose (350-500 ng/mL) microemulsion | DRUG | The dose of cyclosporine for each patient was adjusted to achieve the target cyclosporine blood level. Cyclosporine dose adjustments were based on drug blood level determined from whole blood samples taken 2 hours (± 10 min) after the morning dose. |
Inclusion Criteria: * Patients with functioning graft who had completed the 6-month treatment period of core study * Patients who were receiving treatment with either everolimus and cyclosporin at the end of the core study * Patients who signed the informed consent of the present study extension E...
Everolimus 0.25 and 0.75 mg tablets are used in transplantation infection, specifically in de novo renal transplant recipients. The formulation is studied in combination with cyclosporine microemulsion to prevent organ rejection and manage infection risk after kidney transplantation. It is a small molecule immunosuppressant developed by Novartis AG.
Everolimus 0.25 and 0.75 mg tablets target FKBP1A. The drug acts as an inhibitor of this target, which is part of the immunophilin family involved in immunosuppressive signaling. By binding to FKBP1A, everolimus interferes with pathways that drive T-cell activation and proliferation, reducing immune responses against transplanted organs.
Everolimus 0.25 and 0.75 mg tablets are developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor responsible for the clinical development of this formulation in transplantation.
Everolimus 0.25 and 0.75 mg tablets are in Phase 3 clinical development. The drug is investigational and has been evaluated in a completed Phase 3 trial. It is not described as approved for any indication in the available development information.
Everolimus 0.25 and 0.75 mg tablets have been studied in one Phase 3 clinical trial, NCT01276457, titled Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients. The trial is completed, enrolled 223 participants, was randomized, and used an active-controlled design without double blinding.