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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01843348 | 12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients | PHASE3 | COMPLETED | 612 | — | — | Dec 27, 2012 | Mar 23, 2016 | May 1, 2017 | 27 | France, Germany |
To demonstrate non-inferiority in renal function assessed by glomerular filtration rate (Nankivell formula) in at least one of the Certican® treatment regimens compared to the standard regimen group at month 12 post-transplantation in renal transplant patients. Nankivell formula: GFR = 6.7/Scr + BW/4 - Surea/2 - 100/(height)² + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The eGFR is expressed in mL/min per 1.73m². If a patient was on dialysis at the time of urea or creatinine assessment, the eGFR was set to 0. Analysis set = per protocol set
| Arm | Type | Description |
|---|---|---|
| TAC+MPA | ACTIVE_COMPARATOR | - |
| TAC+Certican | EXPERIMENTAL | - |
| CycA+Certican | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Everolimus | DRUG | - |
| Tacrolimus | DRUG | Capsules: 0.5 mg, 1 mg or 5 mg. Dosing schedule: transplant to month 2: 4-8ng/ml, month 3 to month 12 3-5 ng/ml according to standard blood levels |
| Cyclosporin A | DRUG | Capsules: 10 mg, 25 mg, 50 mg or 100 mg. Transplantation to month 2: 75 - 125 ng/ml, month 3 to month 12: 50 - 100 ng/ml |
| Enteric Coated Mycophenolate Sodium (EC-MPS) | DRUG | Tablets: 180 mg or 360 mg. Dosing: duration of study 360 mg bid and no less than 360 mg daily dose |
| Mycophenolate mofetil (MMF) | DRUG | Capsules: 250 or 500 mg. Dosing: duration of study 500 mg bid and no less than 500 mg total daily dose |
| Corticosteroids | DRUG | A minimum dose of 5 mg prednisolon or equivalent |
| Simulect | DRUG | Lyophilisate in vials with ampoules of sterile water for injection (5 mL), one vial containing 20 mg lyophilisate given intravenously on the day of transplantation and on day four post-transplantation. |
Inclusion Criteria: * Patient who had received a primary or secondary kidney transplant * Patients who were willing and from whom written informed consent was obtained * kidney allograft with a cold ischemia time (CIT) \< 30 hours * negative pregnancy test prior to study enrollment Exclusion Crite...