Clinical Trial

Premarket Clinical Safety Assessment of the ELISIO™-HX

Completed
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Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-07-01; most recent amendment 2026-06-26.
Status change: Recruiting → Completed 2026-03-04
Status change: Not Yet Recruiting → Recruiting 2025-09-09
Trial Details
NCT Number NCT07058909
Lead Sponsor Nipro Medical Corporation
Collaborators: Bright Research Partners
Conditions Renal Failure, Acute Renal Failure, Chronic Renal Failure, Chronic Kidney Diseases, End Stage Renal Disease
Enrollment 22 participants
Start Date 2025-09-08
Primary Completion 2026-02-25 (estimated)
Study Completion 2026-02-25 (estimated)
Updated on ClinicalTrials.gov 2026-03-06