Premarket Clinical Safety Assessment of the ELISIOâ„¢-HX (NCT07058909) | Clinical Trial Compass
CompletedNot Applicable
Premarket Clinical Safety Assessment of the ELISIOâ„¢-HX
United States22 participantsStarted 2025-09-08
Plain-language summary
The primary safety objective of this study is to evaluate the safety of the use of the high-permeability hemodialyzer series ELISIOâ„¢-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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
1
Change in serum level of albumin
Timeframe: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks of treatment with ELISIO-HX
2
Reduction ratio (RR) of lambda (λ) FLC
Timeframe: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks of treatment with ELISIO-HX
✕. Have known bleeding disorders (e.g., gastrointestinal bleeding, colonic polyps, small bowel angiodysplasia, and active peptic ulcers).
✕. 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.
✕. Have active cancer, except for basal cell or squamous cell skin cancer.