2-Year Results on Renal Function and Safety for Everolimus plus Reduced-Exposure Calcineurin Inhibitor in Living Donor Kidney Transplant Recipients
1Division of Renal and Transplantation, Jichi Medical University, Shimotsuke, Japan
2Transplant Surgery, Nagoya Daini Red Cross Hospital, Nagoya, Japan
3Surgery, Kidney Center, Tokyo Women's University, Tokyo, Japan
4Medical Division, Novartis Pharma K.K., Tokyo, Japan.
Meeting: 2015 American Transplant Congress
Abstract number: D134
Keywords: Immunosuppression, Kidney transplantation
Session Information
Date: Tuesday, May 5, 2015
Session Name: Poster Session D: Kidney Immunosuppression: Drug Minimization
Session Time: 5:30pm-6:30pm
Presentation Time: 5:30pm-6:30pm
Location: Exhibit Hall E
Purpose: The long-term effects of everolimus (EVR) with reduced cyclosporine (rCsA) exposure over 24 months on renal function and safety (viral infection) were assessed in kidney transplant recipients (KTxR) receiving allografts from living donors.
Methods: A1202 core study was a 12-month, multicenter, randomized, open-label, non-inferiority study designed to investigate the efficacy and safety of concentration-controlled EVR (1.5 mg/day starting dose, target trough level 3-8 ng/mL) with rCsA exposure versus mycophenolate mofetil (MMF; 2g) with standard CsA exposure in de novo KTxR in Japan. The 24-month study was an extension to the 12-month core study. Here, a retrospective analysis on living donor population from the A1202 study (including 12 months core and extension study results until 24 months) was done and included a further sub-analysis based on the donor age (<50 vs. ≥50 years) to describe the renal function parameter.
Results: At Month 24, the EVR group showed a numerically higher calculated GFR (cGFR, mL/min/1.73 m2) than MMF group (median values, EVR: 58.40 vs. MMF: 54.50; p=0.149). Further, better renal function was observed in EVR group for donor age <50 years (median cGFR: EVR: 78.6 vs. MMF: 53.5) while the MMF group showed a marginal improvement in the median cGFR than EVR group (EVR: 51.8 vs. MMF: 54.5) for donor age ≥50 years. No deaths were reported during the study. Similar incidence of SAEs (60%) were reported for each treatment group and the adverse events (>85%) were mild to moderate in severity in either group. A higher proportion of recipients in MMF group had serious infections (36% EVR vs. 46% MMF) including serious viral infections (14% EVR vs. 32% MMF) with more MMF recipients being CMV test positive (4% EVR vs. 16% MMF). Further, increased blood creatinine was reported for MMF recipients (4% EVR vs. 12% MMF) although slightly higher incidences of proteinuria (10% EVR vs. 4% MMF) were observed in EVR recipients.
Conclusion: The long-term results over 24 months in living donor KTxR demonstrated a numerically higher renal function (cGFR) and less serious infections in EVR group compared to MMF group.
To cite this abstract in AMA style:
Yagisawa T, Ishikawa N, Goto N, Nakajima I, Kamisawa O, Fuchinoue S. 2-Year Results on Renal Function and Safety for Everolimus plus Reduced-Exposure Calcineurin Inhibitor in Living Donor Kidney Transplant Recipients [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/2-year-results-on-renal-function-and-safety-for-everolimus-plus-reduced-exposure-calcineurin-inhibitor-in-living-donor-kidney-transplant-recipients/. Accessed August 25, 2019.« Back to 2015 American Transplant Congress