Premarket Clinical Safety Assessment of the ELISIO™-HX

Prior treatment

• Have had a major bleeding episode (e.g., soft tissue bleeding, blood in stool, prolonged nose bleeds, joint damage, retinal bleeding, extensive mucosal bleeding, exsanguination, cerebral hemorrhage) ≤12 weeks prior to enrolling.
• Have had a blood (red blood cell) transfusion ≤12 weeks prior to enrollment.
• Have had an acute infection ≤4 weeks prior to enrollment.
• Are scheduled for living-donor transplantation within the study period + 3 months, plan to change to peritoneal dialysis (PD) therapy within the next 9 months, plan to change to a home hemodialysis treatment, or plan to relocate to an area where no study center is located.

Other illness

• Have chronic liver disease.
• Have a known paraprotein-associated disease.
• Have known bleeding disorders (e.g., gastrointestinal bleeding, colonic polyps, small bowel angiodysplasia, and active peptic ulcers).
• Have active cancer, except for basal cell or squamous cell skin cancer.
• Have a known polyclonal gammopathy (connective tissue disease, liver disease, chronic infection, lymphoproliferative disorder, or other hematologic condition).
• Have a positive serology test for human immunodeficiency virus or hepatitis infection.
• Have a significant psychiatric disorder or mental disability.
• Have a history of non-compliance with HD as assessed by an investigator.
• Have uncontrolled (systolic BP \> 180 mmHg) hypertension.

Lab values

• Are female and pregnant, lactating, or planning to become pregnant during the study period. Note: Female participants of childbearing potential, defined as a woman \<55 years old who has not had a partial or full hysterectomy or oophorectomy, must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test at screening. Participants of childbearing potential must use a medically acceptable means of contraception during their participation in the study.
• Have a known serum κ/λ FLC ratio that is less than 0.37, or greater than 3.1

Other

• Have a known monoclonal gammopathy (monoclonal gammopathy of uncertain significance, smoldering \[asymptomatic\] multiple myeloma, symptomatic multiple myeloma, plasmacytomas, or plasma cell leukemia).
• Are scheduled for planned interventions requiring hospitalization \>1 week.
• Are currently participating in another interventional clinical study or have participated in another interventional clinical study in the past 3 months.
• Have had a major cardiovascular or cerebrovascular event within 3 months of enrollment.
• Have a history with consistent evidence of intradialytic hypotension.
• Have had adverse reactions to dialyzer materials
• Vulnerable participant populations (e.g., incarcerated or cognitively challenged adults)

• 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.