Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Steroids · 1 trial · 1 indication
Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)
Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)
| Arm | Type | Description |
|---|---|---|
| Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS) | ACTIVE_COMPARATOR | Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids |
| Everolimus + Cyclosporine | ACTIVE_COMPARATOR | Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids |
| Name | Type | Description |
|---|---|---|
| Everolimus + Cyclosporine | DRUG | - |
| Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS) | DRUG | - |
| Steroids | DRUG | - |
Inclusion criteria: * Patients who participated in and completed study CRAD001A2420 Exclusion criteria: * Premature study or study treatment discontinuation in CRAD001A2420 study. * Acute rejection within the 3 months prior to inclusion Other protocol-defined inclusion/exclusion criteria may app...
Steroids is a small molecule being studied for use in renal transplantation. It is currently in Phase 3 clinical development, with one completed trial involving 30 adult patients in France. The drug is being evaluated as part of maintenance therapy for renal transplant recipients.
Steroids is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical research on this small molecule for renal transplantation. The drug is currently in Phase 3 development, though the specific trial has been completed.
Steroids is in Phase 3 clinical development for renal transplantation. The Phase 3 trial, NCT00425308, has been completed. This was an active-controlled, randomized study that enrolled 30 adult patients in France. The drug remains investigational and is not yet approved.
Steroids has one completed Phase 3 clinical trial, NCT00425308, titled 'Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.' The trial enrolled 30 patients in France and was active-controlled.
Steroids is not the same as everolimus. The clinical trial NCT00425308 evaluates everolimus in combination with either cyclosporine microemulsion or enteric-coated mycophenolate sodium. Steroids is the drug being studied, while everolimus is a comparator or combination agent in the trial.