Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00154284 | Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients | PHASE3 | COMPLETED | 114 | — | — | Jul 1, 2005 | Jul 1, 2008 | Aug 9, 2018 | - | — |
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 ...