Premarket Clinical Safety Assessment of the ELISIO™-HX
The primary safety objective of this study is to evaluate the safety of the use of the high-permeability hemodialyzer series ELISIO™-HX, by showing that the pre-dialysis albumin levels are not affected using the investigational dialyzer. The primary efficacy objective is to evaluate the performance of the use of the high permeability hemodialyzer series ELISIO™-HX, by showing that the clearance rate of middle molecular weight lambda (λ) free light chain (FLC) is improved by using the investigational dialyzer.
• End stage renal disease patients on hemodialysis age 22 and older, or between ages 18 and 21 with a weight ≥40 kg.
• Clinically stable as judged by the treating physician and as demonstrated by stable medical history for 30 days prior to enrollment, physical examination, and laboratory testing.
• Hemodialysis therapy with the ELISIO-H dialyzer for at least 3 months immediately prior to study enrollment and expected to survive for the next 12 months.
• Expected to maintain an acceptable urea clearance (Kt/V) with a dialyzer of an approximate surface area of 1.7 m2.
• Currently being dialyzed at an in-center setting, on a schedule of 3 times per week.
• Able to give informed consent after an explanation of the proposed study, and willing to comply with the study requirements for therapy during the entire study treatment period.
• Have a stable functioning vascular access (arteriovenous fistula, graft, or dual lumen tunneled catheter). Stable access should be confirmed by:
‣ Kt/V ≥1.2 for past 2 measurements, and/or
⁃ Achievement of within 15% the prescribed blood flow rate (≥350 ml/min) over 3 treatments prior to study entry Note: must have a flow of ≥350 ml/min at the time of enrollment.
• Participants who have given their informed consent in writing.