Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Steroid · 1 trial · 1 indication
Nankivell's formula for calculated GFR is shown below: GFR \[mL/min\] = 6.7/C + W/4 - UREA/2 - 100/H2+ 35 (25 for females). Where W is body weight at specific visit \[kg\], H is height at specific visit \[m\], C is the serum concentration of creatinine \[mmol/L\], and UREA is the serum concentration of urea \[mmol/L\]. UREA was calculated from blood urea nitrogen (BUN) lab data by: UREA = 2.1441\*BUN. If a GFR value from Nankivell formula was less than 10 \[mL/min\], then the value was assigned as 10 \[mL/min\].
| Arm | Type | Description |
|---|---|---|
| Everolimus (Certican) with Cyclosporine (Neoral) Continuation | ACTIVE_COMPARATOR | Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice. |
| Everolimus (Certican) with Cyclosporine (Neoral) Withdrawal | EXPERIMENTAL | Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice. |
| Name | Type | Description |
|---|---|---|
| Everolimus (Certican) | DRUG | - |
| Cyclosporine (Neoral) | DRUG | - |
| Steroid | DRUG | Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice. |
| Basiliximab (Simulect) | DRUG | - |
Inclusion Criteria: * Recipients of a first renal transplant from a primary cadaveric or non-HLA identical living related donor. * Renal cold ischemic time \< 36 hours. * Age of donor \< 65 years. Exclusion Criteria: * Patients who have received an investigational drug within 4 weeks of baseline ...
Steroid is a small molecule being developed by Novartis AG for use in organ transplantation and renal transplantation. It is currently in Phase 3 clinical development as an investigational therapy for patients receiving kidney transplants.
Steroid is being developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 3 clinical development for organ transplantation and renal transplantation.
Steroid is in Phase 3 clinical development. It is an investigational small molecule being studied for use in organ transplantation and renal transplantation. The drug has not been approved by regulatory authorities and remains in clinical trials.
Steroid has one completed Phase 3 clinical trial, identified as NCT00154284. This trial studied everolimus in a cyclosporine microemulsion-free regimen compared to a low-dose cyclosporine microemulsion regimen in de novo kidney transplant patients, enrolling 114 participants.
The clinical trial for Steroid, NCT00154284, evaluates everolimus in a cyclosporine-free regimen. The drug name Steroid is used in the context of this trial, which compares everolimus-based therapy to a low-dose cyclosporine regimen in kidney transplant patients.