A 52-Week, Multicenter, Prospective, Observational, Non-Interventional, Open-Label Study to Assess the Effectiveness, Safety and Tolerability of Everolimus in Kidney Transplant Patients in Taiwan

S.-M. Wang,¹ P.-C. Lee,² J.-D. Lian,³ K.-H. Shu,⁴ S.-T. Wu,⁵ H.-C. Chen,⁶ C.-C. Huang,⁷ M.-S. Wu,⁸ Y.-C. Tian,⁹ Y.-J. Chiang,¹⁰ Y.-T. Chen,¹¹ H.-P. Wang.¹²

¹National Taiwan University Hospital, Taipei, Taiwan
²National Cheng Kung University Hospital, Tainan, Taiwan
³Chung Shan Medical University Hospital, Taichung, Taiwan
⁴Taichung Veteran's General Hospital, Taichung, Taiwan
⁵TriService General Hospital, Taipei, Taiwan
⁶Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
⁷China Medical University Hospital, Taichung, Taiwan
⁸Taipei Medical University Hospital, Taipei, Taiwan
⁹ChangGung Memorial Hospital–Taipei, Taipei, Taiwan
¹⁰ChangGung Memorial Hospital–LinKou, Taoyuan, Taiwan
¹¹ChangGung Memorial Hospital-Kaohsiung, Kaohsiung, Taiwan
¹²E-Da Hospital, Kaohsiung, Taiwan.

Meeting: 2015 American Transplant Congress

Abstract number: D142

Keywords: Calcineurin, Glomerular filtration rate (GFR), Renal function

Session Information

Session Name: Poster Session D: Kidney Immunosuppression: Drug Minimization

Session Type: Poster Session

Date: Tuesday, May 5, 2015

Session Time: 5:30pm-6:30pm

Presentation Time: 5:30pm-6:30pm

Location: Exhibit Hall E

The study aimed to assess the clinical safety and tolerability of everolimus (EVR) in Taiwan kidney transplant patients.

This study enrolled 203 kidney transplant recipients, between 2011 and 2014, who administered EVR and followed up at weeks 12, 24, and 52. Among them, 131 cases completed the study. EVR was added within 12 months post-transplantation in 73 cases; others after 12 months. The immunosuppressant dosing, renal function and adverse events were recorded.

The average age of 203 patients was 50.2 years old. The overall average EVR trough level was maintained at 3.4 ng/mL at week 52. Calcineurin inhibitor was used in 80.8% of patients (61.1% was tacrolimus based), and 45.3% patients used IMPDH inhibitor. Tacrolimus trough level reduced from 7.9 to 4.3ng/mL after administering EVR. Estimated glomerular filtration rate (eGFR, MDRD) significantly increased from 54.7 to 61.7mL/min/1.73m² at week 52 (p=0.002). There were 8 (3.9%) biopsy-proven acute rejections (BPAR), 5 with Banff classification higher than IIa. There were 3 graft losses and 4 deaths which were not related to EVR. Oral ulcer (22.7%), edema (4.4%) and urinary tract infection (3.4%) were the most reported adverse events related to EVR. There were 3 CMV infections, 1 CMV disease, and 1 BKV nephropathy reported, all were not suspected as related to EVR.

The current regimen exhibited low rates of BPAR, graft loss, and death. No unexpected drug-related adverse events were detected and no other safety concerns were seen after 52 weeks of EVR treatment. In conclusion, everolimus is generally an efficacious, safe and well tolerated immunosuppressive therapy for kidney transplant recipients in Taiwan.

To cite this abstract in AMA style:

Wang S-M, Lee P-C, Lian J-D, Shu K-H, Wu S-T, Chen H-C, Huang C-C, Wu M-S, Tian Y-C, Chiang Y-J, Chen Y-T, Wang H-P. A 52-Week, Multicenter, Prospective, Observational, Non-Interventional, Open-Label Study to Assess the Effectiveness, Safety and Tolerability of Everolimus in Kidney Transplant Patients in Taiwan [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/a-52-week-multicenter-prospective-observational-non-interventional-open-label-study-to-assess-the-effectiveness-safety-and-tolerability-of-everolimus-in-kidney-transplant-patients-in-taiwan/. Accessed November 21, 2024.

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