Premarket Clinical Safety Assessment of the ELISIO™-HX

NCT07058909 | Completed DMC FDA Device

• 1 other identifier: NMC-PRO-0009
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Failure; Acute Renal Failure; Chronic Renal Failure; Chronic Kidney Diseases; End Stage Renal Disease

Keywords

Hemodialyzer; High-permeability hemodialyzer; Expanded hemodialysis (HDx); Expanded solute removal; Medium cutoff (MCO) dialyzer; Dialysis

Outcome Measures

Primary Outcomes (2)

• Change in serum level of albumin

  Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks of treatment with ELISIO-HX

• Reduction ratio (RR) of lambda (λ) FLC

  Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks of treatment with ELISIO-HX

Secondary Outcomes (5)

• Change in Factor VII

  Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks

• Change in Protein C

  Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks

• Change in Factor II

  Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks

• Change in Vitamin A

  Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks

• Change in nPNA(nPCR) [normalized Protein equivalent of Nitrogen Appearance (normalized Protein Catabolic Rate)]

  Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks

Study Arms (1)

ELISIO™-HX Dialyzer

EXPERIMENTAL

The ELISIO™-HX is a single use novel medium cut-off dialyzer that is intended for use as an artificial kidney for the treatment of participants with renal failure.

Device: ELISIO™-HX Dialyzer

Interventions

ELISIO™-HX Dialyzer DEVICE

Following consent, participants will undergo a baseline hemodialysis treatment with their currently used dialyzer, the ELISIO-H™, and following the baseline visit will receive hemodialysis with the investigational device, ELISIO™-HX, three times a week for 12 weeks.

ELISIO™-HX Dialyzer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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 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.
• Have a known serum κ/λ FLC ratio that is less than 0.37, or greater than 3.1
• Have a known monoclonal gammopathy (monoclonal gammopathy of uncertain significance, smoldering \[asymptomatic\] multiple myeloma, symptomatic multiple myeloma, plasmacytomas, or plasma cell leukemia).
• 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.
• Are scheduled for planned interventions requiring hospitalization \>1 week.
• 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.

Sponsors & Collaborators

• Nipro Medical Corporation: lead
• Bright Research Partners: collaborator

Study Sites (1)

Davita Clinical Research

Norfolk, Virginia, 23517, United States

Location

MeSH Terms

Conditions

Renal Insufficiency; Acute Kidney Injury; Kidney Failure, Chronic; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kiranjit Dhillon, MD, MPH

  Davita Norfolk Dialysis Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: September 8, 2025
• Primary Completion: February 25, 2026
• Study Completion: February 25, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)