Trial Outcomes & Findings for Premarket Clinical Safety Assessment of the ELISIO™-HX (NCT NCT07058909)
NCT ID: NCT07058909
Last Updated: 2026-09-03
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks of treatment with ELISIO-HX
Results posted on
2026-09-03
Participant Flow
Participant milestones
| Measure |
ELISIO™-HX Dialyzer
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.
ELISIO™-HX Dialyzer: 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.
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|---|---|
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Overall Study
STARTED
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22
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Overall Study
COMPLETED
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13
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Overall Study
NOT COMPLETED
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9
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Premarket Clinical Safety Assessment of the ELISIO™-HX
Baseline characteristics by cohort
| Measure |
ELISIO™-HX Dialyzer
n=13 Participants
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.
ELISIO™-HX Dialyzer: 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.
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|---|---|
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Age, Continuous
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55.2 years
STANDARD_DEVIATION 12.38 • n=136 Participants
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Sex: Female, Male
Female
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5 Participants
n=136 Participants
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Sex: Female, Male
Male
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8 Participants
n=136 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=136 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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11 Participants
n=136 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=136 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=136 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=136 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=136 Participants
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Race (NIH/OMB)
Black or African American
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9 Participants
n=136 Participants
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Race (NIH/OMB)
White
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3 Participants
n=136 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=136 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=136 Participants
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Region of Enrollment
United States
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13 participants
n=136 Participants
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PRIMARY outcome
Timeframe: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks of treatment with ELISIO-HXOutcome measures
| Measure |
ELISIO™-HX Dialyzer
n=13 Participants
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.
ELISIO™-HX Dialyzer: 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.
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Change in Serum Level of Albumin
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-0.04 g/dL
Standard Deviation 0.419
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PRIMARY outcome
Timeframe: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks of treatment with ELISIO-HXRR (%) 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.
Outcome measures
| Measure |
ELISIO™-HX Dialyzer
n=13 Participants
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.
ELISIO™-HX Dialyzer: 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.
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|---|---|
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Reduction Ratio (RR) of Lambda (λ) FLC
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-11.20 percentage
Standard Deviation 15.237
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SECONDARY outcome
Timeframe: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeksOutcome measures
| Measure |
ELISIO™-HX Dialyzer
n=13 Participants
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.
ELISIO™-HX Dialyzer: 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.
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|---|---|
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Change in Factor VII
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-29.3 ng/mL
Standard Deviation 53.72
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SECONDARY outcome
Timeframe: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeksOutcome measures
| Measure |
ELISIO™-HX Dialyzer
n=13 Participants
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.
ELISIO™-HX Dialyzer: 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.
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|---|---|
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Change in Protein C
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-7.0 percent
Standard Deviation 19.94
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SECONDARY outcome
Timeframe: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeksOutcome measures
| Measure |
ELISIO™-HX Dialyzer
n=13 Participants
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.
ELISIO™-HX Dialyzer: 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.
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|---|---|
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Change in Vitamin A
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-0.095 mg/L
Standard Deviation 0.1628
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SECONDARY outcome
Timeframe: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeksOutcome measures
| Measure |
ELISIO™-HX Dialyzer
n=13 Participants
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.
ELISIO™-HX Dialyzer: 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.
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|---|---|
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Change in nPNA(nPCR) [Normalized Protein Equivalent of Nitrogen Appearance (Normalized Protein Catabolic Rate)]
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0.136 g/kg/d
Standard Deviation 0.6872
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Adverse Events
ELISIO™-HX Dialyzer
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ELISIO™-HX Dialyzer
n=18 participants at risk
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.
ELISIO™-HX Dialyzer: 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.
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|---|---|
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Infections and infestations
Osteomyelitis acute
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5.6%
1/18 • Number of events 1 • Adverse events were collected up to 12 weeks from baseline.
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Infections and infestations
Pneumonia
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5.6%
1/18 • Number of events 1 • Adverse events were collected up to 12 weeks from baseline.
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Infections and infestations
Sepsis
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5.6%
1/18 • Number of events 1 • Adverse events were collected up to 12 weeks from baseline.
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Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
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11.1%
2/18 • Number of events 2 • Adverse events were collected up to 12 weeks from baseline.
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Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
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5.6%
1/18 • Number of events 1 • Adverse events were collected up to 12 weeks from baseline.
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Metabolism and nutrition disorders
Hypervolaemia
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5.6%
1/18 • Number of events 1 • Adverse events were collected up to 12 weeks from baseline.
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Other adverse events
| Measure |
ELISIO™-HX Dialyzer
n=18 participants at risk
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.
ELISIO™-HX Dialyzer: 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.
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|---|---|
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Infections and infestations
Pneumonia
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5.6%
1/18 • Number of events 1 • Adverse events were collected up to 12 weeks from baseline.
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Infections and infestations
Influenza
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5.6%
1/18 • Number of events 1 • Adverse events were collected up to 12 weeks from baseline.
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Injury, poisoning and procedural complications
Vascular access site thrombosis
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16.7%
3/18 • Number of events 3 • Adverse events were collected up to 12 weeks from baseline.
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Metabolism and nutrition disorders
Hypervolaemia
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5.6%
1/18 • Number of events 1 • Adverse events were collected up to 12 weeks from baseline.
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Metabolism and nutrition disorders
Hyponatraemia
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5.6%
1/18 • Number of events 1 • Adverse events were collected up to 12 weeks from baseline.
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Nervous system disorders
Dizziness
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5.6%
1/18 • Number of events 1 • Adverse events were collected up to 12 weeks from baseline.
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Musculoskeletal and connective tissue disorders
Muscle spasms
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27.8%
5/18 • Number of events 8 • Adverse events were collected up to 12 weeks from baseline.
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Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
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5.6%
1/18 • Number of events 1 • Adverse events were collected up to 12 weeks from baseline.
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Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
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5.6%
1/18 • Number of events 1 • Adverse events were collected up to 12 weeks from baseline.
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Respiratory, thoracic and mediastinal disorders
Dyspnoea
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5.6%
1/18 • Number of events 1 • Adverse events were collected up to 12 weeks from baseline.
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Vascular disorders
Hypotension
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16.7%
3/18 • Number of events 7 • Adverse events were collected up to 12 weeks from baseline.
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Vascular disorders
Haemorrhage
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5.6%
1/18 • Number of events 1 • Adverse events were collected up to 12 weeks from baseline.
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Vascular disorders
Jugular vein occlusion
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5.6%
1/18 • Number of events 1 • Adverse events were collected up to 12 weeks from baseline.
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Gastrointestinal disorders
Vomiting
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11.1%
2/18 • Number of events 2 • Adverse events were collected up to 12 weeks from baseline.
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Gastrointestinal disorders
Impaired gastric emptying
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5.6%
1/18 • Number of events 1 • Adverse events were collected up to 12 weeks from baseline.
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Additional Information
Jessica Oswald-McLeod, Director, Regulatory Affairs
Nipro Medical Corporation
Phone: +1 305-432-6699
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60