drugset / Trial / NCT01843348
12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2012-12-27
- Primary completion
- 2016-03-23
- Completion
- 2016-03-23
Publications
- Philippe A, Arns W, Ditt V, Hauser IA, Thaiss F, Sommerer C, Suwelack B, Dragun D, Hillen J, Schiedel C, Elsasser A, Nashan B. Impact of everolimus plus calcineurin inhibitor on formation of non-HLA antibodies and graft outcomes in kidney transplant recipients: 12-month results from the ATHENA substudy. Front Transplant. 2023 Nov 21;2:1273890. doi: 10.3389/frtra.2023.1273890. eCollection 2023.
- Sommerer C, Suwelack B, Dragun D, Schenker P, Hauser IA, Nashan B, Thaiss F. Design and rationale of the ATHENA study--A 12-month, multicentre, prospective study evaluating the outcomes of a de novo everolimus-based regimen in combination with reduced cyclosporine or tacrolimus versus a standard regimen in kidney transplant patients: study protocol for a randomised controlled trial. Trials. 2016 Feb 17;17:92. doi: 10.1186/s13063-016-1220-9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclosporin A | Unknown | — | — |
| Comparator | Enteric Coated Mycophenolate Sodium (EC-MPS) | Unknown | 360 mg | — |
| Subject | Everolimus | Small molecule | 1.5 mg | — |
| Subject | Everolimus | Small molecule | 3 mg | — |
| Comparator | Mycophenolate mofetil (MMF) | Unknown | 500 mg | — |
| Subject | Tacrolimus | Small molecule | — | — |
| Background | Basiliximab | Monoclonal antibody | 20 mg | Intravenous |
| Background | Corticosteroids | Unknown | 5 mg | — |
Indications
No indication recorded.