Date: Tuesday, May 5, 2015
Session Time: 5:30pm-6:30pm
Presentation Time: 5:30pm-6:30pm
Location: Exhibit Hall E
Purpose: To evaluate the long-term efficacy and safety of everolimus (EVR) plus reduced cyclosporine (rCsA) compared to mycophenolate mofetil (MMF) plus standard cyclosporine at 24 months in living-donor kidney transplant recipients (KTxR).
Methods: A1202 core study was a 12-month, multi-center, open-label, randomized, non-inferiority study designed to investigate the efficacy and safety of concentration-controlled EVR (1.5 mg starting dose with target trough level 3-8 ng/mL) plus rCsA dose versus MMF (2g) with standard CsA dose in de novo kidney transplant recipients (KTxR) in Japan. The 24-month study was an extension to the 12-month core study. The primary objective was to compare the renal function between the two treatment groups at 24 months post kidney transplantation. The secondary objectives were efficacy failure rates [composite of treated biopsy-proven acute rejection (BPAR), graft loss, death or loss to follow-up], and safety endpoints (incidence of SAE's and AE's) at Month 24. Here, we did a retrospective sub-analysis of data from A1202 study (including 12 months core and extension study results until 24 months) in living-donor KTxR.
Results: The composite efficacy failure event rates (incidence of treated BPAR, graft loss, death or loss to follow-up) were comparable for both treatment groups (8.2% EVR vs. 10.2% MMF). There were no episodes of antibody mediated rejection over 24 months in either treatment group. The EVR group showed a numerically higher calculated GFR (MDRD) than MMF group (median values, EVR: 58.40 vs. MMF: 54.50 mL/min/1.73 m2; p=0.149) at Month 24. The adverse events (AEs) were generally mild to moderate in severity and comparable between the two groups. A higher proportion of recipients in MMF group (32%) had serious viral infections than EVR group (14%) while hyperlipidemia AEs were more frequently reported (72% EVR vs. 48% MMF) for the EVR group.
Conclusion: In living-donor KtxR, the incidence of composite efficacy failure event rates and the numerically higher renal function (calculated GFR) were in favor of EVR than MMF group with comparable safety findings for both the treatment groups over 24 months.
To cite this abstract in AMA style:Watarai Y, Akutsu N, Saito K, Nakagawa Y, Kamisawa O, Kenmochi T. Everolimus Plus Reduced-Exposure Calcineurin Inhibitor Versus Mycophenolate Mofetil Plus Standard-Exposure Calcineurin Inhibitor: 2-Year Results in Living Donor Kidney Transplant Recipients [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/everolimus-plus-reduced-exposure-calcineurin-inhibitor-versus-mycophenolate-mofetil-plus-standard-exposure-calcineurin-inhibitor-2-year-results-in-living-donor-kidney-transplant-recipients/. Accessed January 23, 2020.
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