12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients (ATHENA)
12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients (ATHENA)
This study was designed to evaluate the renal function comparing Certican based immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a standard treatment with Mycophenolic Acid and Tacrolimus in de novo renal transplant recipients.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 612 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 12 Month, Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Certican® Based Regimen Either in Combination With Cyclosporin A or Tacrolimus
Actual Study Start Date: December 27, 2012
Actual Primary Completion Date: March 23, 2016
Actual Study Completion Date: March 23, 2016
Arm:
- Active Comparator: TAC+MPA
- Experimental: TAC+Certican
- Experimental: CycA+Certican
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 612 |
| Study start date | 27 December 2012 |
| Estimated primary completion date | 23 March 2016 |