Abstract: FR-PO474
Clinical Study to Assess the Performance of a Novel Dialyzer with Endexo™ in ESRD Subjects
Session Information
- Hemodialysis and Frequent Dialysis - IV
November 08, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 701 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Meyer, Jill M., Balboa Nephrology Medical Group, La Jolla, California, United States
- Steer, Dylan, Balboa Nephrology Medical Group, La Jolla, California, United States
- Weber, Lisa A., Kansas Nephrology Physicians, P.A., Wichita, Kansas, United States
- Zeitone, Abeer A., Fresenius Medical Care North America, Waltham, Massachusetts, United States
- Thakuria, Mayuri, Fresenius Medical Care North America, Waltham, Massachusetts, United States
- Ho, Chiang-Hong, Fresenius Medical Care North America, Waltham, Massachusetts, United States
- Vemula, Sharanya, Fresenius Medical Care North America, Waltham, Massachusetts, United States
- Aslam, Shakil, Fresenius Medical Care North America, Waltham, Massachusetts, United States
- Mullon, Claudy, Fresenius Medical Care North America, Waltham, Massachusetts, United States
- Kossmann, Robert J., Fresenius Medical Care North America, Waltham, Massachusetts, United States
Background
Surface modifying macromolecules (SMM) may improve the hemocompatibility of hemodialyzers in the development of heparin free hemodialysis (HD). The aim of this clinical trial was to assess the performance and safety of a new dialyzer using a novel fluorinated SMM additive (Endexo™) in ESRD Subjects.
Methods
This prospective, sequential, multi-center, open-label study (NCT# 03536663) was designed according to the FDA’s Guidance for the premarket testing of hemodialyzers. Adult subjects, prescribed thrice-weekly HD for at least 180 days, were enrolled at 3 HD clinics in the US. After completing 12 HD sessions (4 weeks) with an Optiflux® F160NR dialyzer (Opti), subjects received 36 HD sessions with the dialyzer with Endexo (EndX). Evaluated parameters included spKt/V, URR, albumin, β2-microglobulin (β2M), complement activation for Opti and EndX, and hemoglobin and platelet count for EndX only.
Results
A total of 23 subjects (60.5±15.1 yr., BW 70.9±17.4 kg, 17 males) were enrolled and 17 subjects completed the study, 6 subjects were withdrawn due to missed visits not related to the dialyzers. Mean treatment times (208 vs. 207 min), blood flow rates (447.7 vs. 447.5 ml/min), dialysate flow rates (698.5 vs. 698.0 ml/min), URR (80%± 8 vs. 80.2%±4.8) and spKt/V (2.0±0.43 vs. 1.9±0.31) were comparable for EndX and Opti, respectively. There was no evidence of overt complement activation as C5a and C3a levels remained unchanged from pre-HD, and a slight trend for increase in sC5b-9 levels at 30 min was observed for both dialyzers. Comparable increase in serum albumin was observed from pre to post HD, 7.45%±8.5 Opti and 7.40%±7.4 EndX, however, β2M removal rate was 67% higher with EndX vs. Opti. Post-HD hemoglobin increased by 4.75%±8.2 vs. pre-HD (EndX), and post-HD platelet count decreased by 2.7%±5.6 vs. pre-HD (EndX). Three serious adverse events were reported, none of them were device related.
Conclusion
In a prospective, sequential, multi-center, open-label clinical trial, the Optiflux dialyzer and the novel dialyzer with Endexo were well tolerated with high URR and spKT/V. The β2-microglobulin removal efficiency was 67% higher with the dialyzer with Endexo.
Funding
- Commercial Support –