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Cyclosporin A · 1 trial · 2 indications
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...
Cyclosporin A is an investigational small molecule being studied for use in kidney transplantation. It is being evaluated as part of a treatment regimen for patients undergoing de novo kidney transplantation, which refers to patients receiving a kidney transplant for the first time.
Cyclosporin A is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the drug's safety and efficacy in the kidney transplantation setting.
Cyclosporin A is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to determine its safety and effectiveness for use in kidney transplantation.
Cyclosporin A is being studied in a Phase 3 clinical trial identified as NCT01843348, titled "12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients." This completed trial enrolled 612 participants across France and Germany, with participants aged 18 years and older.
No, Cyclosporin A is not the same as everolimus. In the Phase 3 clinical trial NCT01843348, Cyclosporin A is part of the standard regimen being compared against everolimus. The trial is designed to evaluate the two different treatment approaches in de novo kidney transplant patients.
The Phase 3 study for Cyclosporin A, NCT01843348, was a randomized, active-controlled trial. It was not double-blinded, meaning participants and investigators knew which treatment was being administered. The study compared Cyclosporin A-based standard therapy against an everolimus-based regimen in kidney transplant recipients.