Table 3 Objectives of the ATHENA study
Primary objective | |
• | To demonstrate non-inferiority in renal function (estimated GFR by the Nankivell formula) in at least one of the everolimus arms compared with the standard regimen at month 12 post transplantation |
Key secondary objectives | |
• | To assess the incidence of treatment failure (composite of biopsy-proven acute rejection, graft loss, or death) at month 12 post transplantation |
Other secondary objectives | |
To evaluate the following: | |
• | GFR by different formulae (CKD-EPI, Cockcroft-Gault and MDRD) |
• | Incidence of individual efficacy endpoints: biopsy-proven acute rejection, graft loss, and death |
• | Incidence and severity of viral infections (CMV, BKV) |
• | Incidence and duration of delayed graft function |
• | Incidence of slow graft function defined as serum creatinine >3.0 mg/dL at day 5 |
• | Incidence of wound healing complications related to the surgery and the duration of healing |
• | Overall safety and tolerability (incidence of AEs and serious AEs, infections, discontinuation due to AEs, and laboratory abnormalities) at month 12 post transplantation |
Exploratory objectives | |
• | To compare HLA- and non-HLA antibody evolution at baseline and month 12 post transplantation |
• | To evaluate left ventricular hypertrophy (assessed by LV mass index) and diastolic dysfunction |
• | The incidence of donor-specific antibodies by treatment group, and its association with acute rejection |
• | Analysis of general immunomodulatory effects on lymphocyte subpopulations and on the incidence and antigen-specific immune control of CMV infections |