Renal FailureNCT07058909
Premarket Clinical Safety Assessment of the ELISIO™-HX
A study testing ELISIO™-HX Dialyzer in people with Renal Failure and Acute Renal Failure, run by Nipro Medical Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Acute Renal Failure, Chronic Renal Failure
- What is being tested?
- ELISIO™-HX Dialyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2025to 25 Feb 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Are currently participating in another interventional clinical study or have participated in another interventional clinical study in the past 3 months.
- Have a history of non-compliance with HD as assessed by an investigator.
- Have had a major cardiovascular or cerebrovascular event within 3 months of enrollment.
- Have a history with consistent evidence of intradialytic hypotension.
- Have uncontrolled (systolic BP > 180 mmHg) hypertension.
- Have had adverse reactions to dialyzer materials
- Vulnerable participant populations (e.g., incarcerated or cognitively challenged adults)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- ELISIO™-HX Dialyzer
- Keywords
- Hemodialyzer, High-permeability hemodialyzer, Expanded hemodialysis, Expanded solute removal, Medium cutoff dialyzer, Dialysis
- Medical subject headings
- Renal Insufficiency, Acute Kidney Injury, Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISIO™-HX DialyzerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ELISIO™-HX Dialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Level of Albumin
Measured: 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
RR (%) is derived as ([post-baseline value - baseline value] / baseline value) x 100. A negative mean RR indicates increased removal of λ FLC after treatment compared to baseline.
Measured: 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 (4)
Change in Factor VII
Measured: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks
Change in Protein C
Measured: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks
Change in Vitamin A
Measured: 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)]
Measured: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start8 Sep 2025
- Primary completion25 Feb 2026
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nipro Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Responsible party
- Sponsor
- Investigators
- Kiranjit Dhillon, MD, MPH, Principal investigator, Davita Norfolk Dialysis Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058909
- Sponsor's protocol ID
- NMC-PRO-0009
- Status last verified
- Sep 2026
- First submitted
- 1 Jul 2025
- Last updated
- 3 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premarket Clinical Safety Assessment of the ELISIO™-HX
- ClinicalTrials.gov ID
- NCT07058909
- Acronym / sponsor ID
- NMC-PRO-0009
- Conditions
- Renal Failure, Acute Renal Failure, Chronic Renal Failure, Chronic Kidney Diseases, End Stage Renal Disease
- Keywords
- Hemodialyzer, High-permeability hemodialyzer, Expanded hemodialysis, Expanded solute removal, Medium cutoff dialyzer, Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Nipro Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 10 Jul 2025 (actual)
- Results
- Posted 3 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ELISIO™-HX Dialyzer | Experimental | Device: ELISIO™-HX DialyzerThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISIO™-HX DialyzerFollowing 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. | Device | ELISIO™-HX Dialyzer |
Primary outcome
Change in Serum Level of Albumin
Time frame: 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
Time frame: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks of treatment with ELISIO-HX
RR (%) is derived as ([post-baseline value - baseline value] / baseline value) x 100. A negative mean RR indicates increased removal of λ FLC after treatment compared to baseline.
4 secondary outcomes
Change in Factor VII
Time frame: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks
Change in Protein C
Time frame: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks
Change in Vitamin A
Time frame: 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)]
Time frame: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiranjit Dhillon, MD, MPH principal investigator
Davita Norfolk Dialysis Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELISIO™-HX Dialyzer in people with Renal Failure and Acute Renal Failure, run by Nipro Medical Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Level of Albumin (time frame: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks of treatment with ELISIO-HX). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.