Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Prednison · 1 trial · 2 indications
Occurrence or not of treatment failure in each patient. Treatment failure was defined as a composite endpoint of biopsy-proven acute rejection (a biopsy graded IA, IB, IIA, IIB or III according to Banff '97 grading with 2007 update), graft loss, death or lost to follow-up occurring after randomization (V5) and within M12 (V9).
| Arm | Type | Description |
|---|---|---|
| Group A -Once-a-day regimen | EXPERIMENTAL | Everolimus: in patients randomized to Group A before Amendment 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12. Cyclosporine: in patients randomized to Group A before Amendment 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL. Prednisone: In patients randomized to Group A before Amendment 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning. |
| Group B - Steroid Withdrawal group | EXPERIMENTAL | Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12. Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12. Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks. |
| Group C - Standard twice-a-day group | ACTIVE_COMPARATOR | Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12. Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12. Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning. |
| Not Randomized Population (NRP) | EXPERIMENTAL | NRP defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as "not randomized patients" (NRP) and described with respect to baseline characteristics, treatment and outcome variables. |
| Name | Type | Description |
|---|---|---|
| everolimus | DRUG | Everolimus (Certican®) was provided in blisters containing tablets of 0.25 mg and 0.75 mg. Everolimus was initiated within 48 hours after graft reperfusion and it was administered orally. |
| cyclosporine | DRUG | Cyclosporine for microemulsion (CsA, Sandimmun® Neoral®) was coadministered with everolimus at the same time of the day. CsA was available in alu-alu blisters containing soft gelatine capsules of 100 mg, 50 mg, 25 mg and 10 mg. Oral solution, as bottles containing 50 mL of solution (100 mg/mL) has been provided and used in case the drug had been administered to patients by nasogastric tube immediately after transplant. |
| Prednison (continuous steroids) | DRUG | continuous steroids |
Inclusion criteria: * recipients of 1st or 2nd single kidney transplant * donor age \>14 years * females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at Baseline (Visit 2), and are required to practice an approved method of birth control for the d...
Prednison is an investigational small molecule being studied for use in de Novo Kidney Transplant Recipients, a condition related to renal transplantation. It is being evaluated as part of a once-a-day regimen in combination with everolimus and low dose cyclosporine, with or without steroid withdrawal, in a Phase 3 clinical trial.
Prednison is a corticosteroid, a class of drugs that work by suppressing the immune system to prevent organ rejection. In the context of kidney transplantation, it is used to reduce the activity of the immune system so the recipient's body does not attack the transplanted kidney.
Prednison is being developed by Novartis AG, a multinational pharmaceutical company. The company is listed on the stock exchange under the ticker symbol NVS.
Prednison is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and efficacy in de Novo Kidney Transplant Recipients.
Prednison is being studied in a Phase 3 clinical trial with the identifier NCT01023815. This completed trial enrolled 330 participants in Italy and evaluated a once-a-day regimen with everolimus, low dose cyclosporine and steroids, comparing it to steroid withdrawal or a twice-a-day regimen.
Prednison is a name that may be confused with prednisone, a commonly used corticosteroid. However, the information provided does not indicate that Prednison is the same as prednisone. It is an investigational drug being developed by Novartis for use in kidney transplant recipients.