End Stage Renal Disease (ESRD)NCT02433210

A Clinical Study Comparing Basic Performance and Hemocompatibility of 3 Different Dialyzers in Hemodialysis Patients

A study testing ELISIO-15H, Revaclear and Optiflux in people with End Stage Renal Disease (ESRD), run by University of Missouri-Columbia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of the study is to confirm the safety and clinical effectiveness of Nipro ELISIO-15H and to compare its performance characteristics and hemocompatibility with those of the commercially available dialyzers in U.S.A., Gambro Polyflux Revaclear and Fresenius F160NRe. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: End Stage Renal Disease (ESRD)
What is being tested?: ELISIO-15H, Revaclear and Optiflux
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: Jun 2015to 31 Aug 2018
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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

ESRD patients 18 years or older
Stable on hemodialysis for more than 3 months
Stable hemoglobin between 11-12 g/dl
Stable arteriovenous (AV) fistula vascular access
Stable anticoagulation and ESA regimen
No active infection
Able to sign informed consent and able to participate in the study
Medically stable

Who cannot join

Participation in another study which may interfere with the planned study
Active infection
Medical conditions which may interfere with the study (cardiac, liver disease, Hepatitis)
Allergy to dialyzer membrane materials e.g. polysulfone
Patients which cannot tolerate Heparin
Female who are pregnant or planning to be pregnant
Problem with or allergy to anticoagulation

Trial locations and contacts

1 site in 1 country.

United States1 site

Dialysis Clinic Incorporated
Columbia, Missouri, 65201

Other trials in United States

About this study

Official title: A Clinical Study Comparing the Basic Performance and Blood Compatibility Characteristics of Nipro ELISIO-H, Gambro Polyflux Revaclear and Fresenius Optiflux Dialyzers

10 stable patients will be dialyzed 3 times/week with each dialyzer over 3 weeks. Blood samples for several parameters will be collected during hemodialysis to assess the performance and hemocompatibility of the dialyzers under study. Data thus collected will be analyzed for comparison by standard statistical analysis.

Read the detailed description

Current patients receiving dialysis treatment for end stage renal disease and who meet the inclusion/exclusion criteria will be entered into the study. These patients will continue on their standard dialysis regimen as stated in the clinics Standard Operating Procedures. Each patient will be studied for three weeks with each week starting with a dialyzer of a different manufacture but of comparable characteristics. Solute clearances and removal will be determined at each of the three dialysis sessions during the week. During session 2 of each week additional specimens will be taken to analyze for hemocompatibility. At the end of the study all clearances and the hemocompatibility markers for each dialyzer will be compared to one another as well as to the manufactures stated characteristics. Blood for the clearance and removal calculations will be taken at time 0, 60 minutes and 240 minutes. Blood for the hemocompatibility determinations will be taken at time 0, 15, 30, 60 and 240 minutes. Flow rates, anticoagulant therapy, erythropoietin therapy, venous and arterial pressures will also be recorded.

Conditions: End Stage Renal Disease (ESRD)
Being tested: ELISIO-15H, Revaclear, Optiflux
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ELISIO-15HDevice
Also called dialyzer
Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
RevaclearDevice
Also called Dialyzer
Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
OptifluxDevice
Also called Dialyzer
Each patient to undergo 3 successive hemodialysis/week with this dialyzer.

Study groups in NCT02433210
Study group	Role	What they receive
Solute Clearance	Active comparator	Solute clearance at 60 minutes for urea, creatinine, phosphate, beta 2 microglobulin, and myoglobin will be determined three times for ELISIO-15H, Revaclear and Optiflux 160NR dialyzers at the 60 minute time point. Receives: Device: ELISIO-15H; Device: Revaclear; Device: Optiflux
Hemocompatibility	Active comparator	Hemocompatibility will be determined using the markers C3a, C5a, thrombin/anti-thrombin complex and complete blood count with platelets will be determined one time for each dialyzer at session 2 and at time points 0, 15, 30, 60, and 240 minutes for ELISIO-15H, Revaclear and Optiflux 160NR dialyzers .. Receives: Device: ELISIO-15H; Device: Revaclear; Device: Optiflux
Solute removal rate	Active comparator	Solute (urea, creatinine, phosphate, beta 2 macroglobulin, and myoglobin) removal rate will be determined time points 0 and 240 minutes for ELISIO-15H, Revaclear and Optiflux 160NR dialyzers . Receives: Device: ELISIO-15H; Device: Revaclear; Device: Optiflux

What is being measured

The primary outcome is the main question the study is designed to answer.

Clearance and Solute Removal Characteristics of Dialyzers
Clearances of small, middle and large molecular weight solutes will be measured at 60 minute time point utilizing urea, creatinine, beta 2 microglobulin, phosphate and myoglobin. Dialyzer clearance is calculated as follows: 60 minute clearance:((([S]60'Art - [S]60'Ven) / [S]60'Art) * Qb) where [S] = solute concentration; Qb = blood flow rate. S
Measured: During each of the three weekly dialysis sessions measurements of urea were made at the 60 minute time point for each patient in the study. At the end of the study all measurements were summed for each of the three dialyzers.
Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers
The molecules monitored will be C5a, thrombin/anti-thrombin complex and a complete blood count with platelets.
Measured: Once a week during the second of the three weekly sessions specimens will be taken at time points 0, 15, 30, 60 and 240 minutes. Measurements, all patients, were summed for each dialyzer type by time period.
Hemocompatibility as Shown by Thrombin/Antithrombin Complex for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers.
Measure of the % change from Baseline for the hemocompatibility marker Thrombin/Antithrombin complex for the Optiflux, Revaclear, and ELISIO dialyzers.
Measured: Once a week during the second of the three weekly sessions specimens will be taken at the 60 and 240 minutes timepoints. Measurements for all patients were summed for each dialyzer type by time period for analysis..
Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers
Measure of the % change from Baseline for the hemocompatibility marker Hematocrit for the Optiflux, Revaclear, and ELISIO dialyzers.
Measured: Once a week during the second of three weekly sessions samples will be taken at the 0, 15, 30, 60, and 240 minute timepoints. Measurements for all patients were summed for each dialyzer type by time period for analysis.
Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers
Measure of the % change from Baseline for the hemocompatibility marker Hemoglobin for the Optiflux, Revaclear, and ELISIO dialyzers.
Measured: Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time points. Measurements for all patients were summed for each dialyzer type and time point for analysis.
Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers
Measure of the % change from Baseline for the hemocompatibility marker White Cell Count for the Optiflux, Revaclear, and ELISIO dialyzers.
Measured: Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time periods. All measurements for all patients were summed for each dialyzer type and time point.
Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers
Measure of the % change from Baseline for the hemocompatibility marker Platelets for the Optiflux, Revaclear, and ELISIO dialyzers.
Measured: Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time periods. All measurements for all patients were summed for each dialyzer type and time point.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 201531 Aug 2018

First posted4 May 2015 (estimated)
Study startJun 2015
Primary completion30 Nov 2017
Study completion31 Aug 2018

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 End Stage Renal Disease (ESRD)Studies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02433210
Sponsor's protocol ID: 2002150
Status last verified: Aug 2022
First submitted: 16 Dec 2014
Last updated: 5 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All End Stage Renal Disease (ESRD) trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study Comparing the Basic Performance and Blood Compatibility Characteristics of Nipro ELISIO-H, Gambro Polyflux Revaclear and Fresenius Optiflux Dialyzers
ClinicalTrials.gov ID: NCT02433210
Acronym / sponsor ID: 2002150
Conditions: End Stage Renal Disease (ESRD)
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: University of Missouri-ColumbiaUniversity, hospital or other
Collaborators: Nipro Medical Corporation, Dialysis Clinic, Inc.
Study start: Jun 2015
Primary completion: 30 Nov 2017 (actual)
Study completion: 31 Aug 2018 (actual)
First posted: 4 May 2015 (estimated)
Results: Posted 5 Aug 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Solute Clearance	Active comparator	Device: ELISIO-15H, Device: Revaclear, Device: OptifluxSolute clearance at 60 minutes for urea, creatinine, phosphate, beta 2 microglobulin, and myoglobin will be determined three times for ELISIO-15H, Revaclear and Optiflux 160NR dialyzers at the 60 minute time point.
Hemocompatibility	Active comparator	Device: ELISIO-15H, Device: Revaclear, Device: OptifluxHemocompatibility will be determined using the markers C3a, C5a, thrombin/anti-thrombin complex and complete blood count with platelets will be determined one time for each dialyzer at session 2 and at time points 0, 15, 30, 60, and 240 minutes for ELISIO-15H, Revaclear and Optiflux 160NR dialyzers ..
Solute removal rate	Active comparator	Device: ELISIO-15H, Device: Revaclear, Device: OptifluxSolute (urea, creatinine, phosphate, beta 2 macroglobulin, and myoglobin) removal rate will be determined time points 0 and 240 minutes for ELISIO-15H, Revaclear and Optiflux 160NR dialyzers .

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

ESRD patients 18 years or older
Stable on hemodialysis for more than 3 months
Stable hemoglobin between 11-12 g/dl
Stable arteriovenous (AV) fistula vascular access
Stable anticoagulation and ESA regimen

Key exclusion criteria (7 listed)

Participation in another study which may interfere with the planned study
Active infection
Medical conditions which may interfere with the study (cardiac, liver disease, Hepatitis)
Allergy to dialyzer membrane materials e.g. polysulfone
Patients which cannot tolerate Heparin

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-15HAlso: dialyzerEach patient to undergo 3 successive hemodialysis/week with this dialyzer.	Device	Hemocompatibility, Solute Clearance, Solute removal rate
RevaclearAlso: DialyzerEach patient to undergo 3 successive hemodialysis/week with this dialyzer.	Device	Hemocompatibility, Solute Clearance, Solute removal rate
OptifluxAlso: DialyzerEach patient to undergo 3 successive hemodialysis/week with this dialyzer.	Device	Hemocompatibility, Solute Clearance, Solute removal rate

Primary outcome

Clearance and Solute Removal Characteristics of Dialyzers
Time frame: During each of the three weekly dialysis sessions measurements of urea were made at the 60 minute time point for each patient in the study. At the end of the study all measurements were summed for each of the three dialyzers.
Clearances of small, middle and large molecular weight solutes will be measured at 60 minute time point utilizing urea, creatinine, beta 2 microglobulin, phosphate and myoglobin. Dialyzer clearance is calculated as follows: 60 minute clearance:((([S]60'Art - [S]60'Ven) / [S]60'Art) * Qb) where [S] = solute concentration; Qb = blood flow rate. S
Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers
Time frame: Once a week during the second of the three weekly sessions specimens will be taken at time points 0, 15, 30, 60 and 240 minutes. Measurements, all patients, were summed for each dialyzer type by time period.
The molecules monitored will be C5a, thrombin/anti-thrombin complex and a complete blood count with platelets.
Hemocompatibility as Shown by Thrombin/Antithrombin Complex for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers.
Time frame: Once a week during the second of the three weekly sessions specimens will be taken at the 60 and 240 minutes timepoints. Measurements for all patients were summed for each dialyzer type by time period for analysis..
Measure of the % change from Baseline for the hemocompatibility marker Thrombin/Antithrombin complex for the Optiflux, Revaclear, and ELISIO dialyzers.
Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers
Time frame: Once a week during the second of three weekly sessions samples will be taken at the 0, 15, 30, 60, and 240 minute timepoints. Measurements for all patients were summed for each dialyzer type by time period for analysis.
Measure of the % change from Baseline for the hemocompatibility marker Hematocrit for the Optiflux, Revaclear, and ELISIO dialyzers.
Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers
Time frame: Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time points. Measurements for all patients were summed for each dialyzer type and time point for analysis.
Measure of the % change from Baseline for the hemocompatibility marker Hemoglobin for the Optiflux, Revaclear, and ELISIO dialyzers.
Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers
Time frame: Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time periods. All measurements for all patients were summed for each dialyzer type and time point.
Measure of the % change from Baseline for the hemocompatibility marker White Cell Count for the Optiflux, Revaclear, and ELISIO dialyzers.
Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers
Time frame: Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time periods. All measurements for all patients were summed for each dialyzer type and time point.
Measure of the % change from Baseline for the hemocompatibility marker Platelets for the Optiflux, Revaclear, and ELISIO dialyzers.

Results and safety

Results posted to the registry on 5 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental: ELISIO, Then Revaclear, Then Optiflux	5	4
Experimental: Revaclear, Then Optiflux, Then ELISIO	3	3
Experimental: Optiflux, Then ELISIO, Then Revaclear	3	3

Primary outcome: Clearance and Solute Removal Characteristics of Dialyzers

Time frame: During each of the three weekly dialysis sessions measurements of urea were made at the 60 minute time point for each patient in the study. At the end of the study all measurements were summed for each of the three dialyzers.. Mean (Standard Deviation). Unit: milliliters per minute (ml/min)

Measure	BUN Clearance Optiflux n = 10	BUN Clearance Revaclear n = 10	BUN Clearance Elisio n = 10	Creatinine Clearance Optiflux n = 10	Creatinine Clearance Revaclear n = 10	Creatinine Clearance ELISIO n = 10	Phosphate Clearance Optiflux n = 10	Phosphate Clearance Revaclear n = 10	Phosphate Clearance Elisio n = 10	Beta 2 Microglobulin Revaclear n = 10	Beta 2 Microglobulin Optiflux n = 10	Beta 2 Microglobulin ELISIO n = 10	Myoglobin Clearance Optiflux n = 10	Myoglobin Clearance Revaclear n = 10	Myoglobin Clearance ELISIO n = 10
Session 1	354.1 (48)	340.4 (72.5)	361.8 (51)	271.8 (65.2)	295.9 (53.7)	298.4 (49.3)	309.8 (71)	324.8 (60.5)	333.1 (48.3)	137.6 (38.7)	57.2 (41.5)	169.1 (59.6)	-7.1 (29)	24.5 (57.6)	33.4 (47.4)
Session 2	336.2 (57.4)	352.8 (40.1)	356.3 (44.1)	256.7 (78.6)	297.6 (39.9)	293.4 (37)	306.4 (43)	324.7 (45.3)	277 (90.3)	144 (26.8)	63 (49.7)	165.7 (51.5)	-2.6 (26.4)	32.6 (53.5)	19.1 (64.3)
Session 3	331.9 (62.9)	318.8 (69.4)	355.7 (58.3)	277.8 (59.2)	275.5 (39.2)	296.6 (33.3)	296.6 (69.7)	276.6 (100.9)	330.4 (47.9)	149.6 (28)	61.4 (24.7)	136.4 (90.3)	-8.6 (12.6)	62.1 (108.2)	45.5 (40)

Beta 2 Microglobulin Revaclear vs Beta 2 Microglobulin Optiflux: p <0.001, t-test, 2 sided
Beta 2 Microglobulin Optiflux vs Beta 2 Microglobulin ELISIO: p <0.001, t-test, 2 sided
Beta 2 Microglobulin Revaclear vs Beta 2 Microglobulin ELISIO: p =0.178, t-test, 2 sided

Primary outcome: Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers

Time frame: Once a week during the second of the three weekly sessions specimens will be taken at time points 0, 15, 30, 60 and 240 minutes. Measurements, all patients, were summed for each dialyzer type by time period.. Mean (Standard Deviation). Unit: Percent change from baseline

Measure	% Change in C5a at 15 Minutes Optiflux n = 10	% Change in C5a at 15 Minutes Revaclear n = 8	%Change in C5a at 15 Minutes ELISIO n = 10	% Change in C5a at 30 Minutes Optiflux n = 10	% Change in C5a at 30 Minutes Revaclear n = 8	% Change in C5a at 30 Minutes ELISIO n = 10	% Change in C5a at 60 Minutes Optiflux n = 9	% Change in C5a at 60 Minutes Revaclear n = 8	% Change in C5a at 60 Minutes ELISIO n = 10	% Change in C5a at 240 Minutes Optiflux n = 10	% Change in C5a at 240 Minutes Revaclear n = 8	% Change in C5a at 240 Minutes ELISIO n = 10
Value	8.5 (28.0)	-5.1 (26.8)	-4.5 (15.4)	11.2 (17.8)	7.5 (25.3)	-1.1 (19.6)	-17.7 (22.8)	-9.8 (22.7)	-6.1 (35.4)	15.9 (15.6)	-6.6 (14.3)	1 (31.7)

% Change in C5a at 15 Minutes Optiflux vs % Change in C5a at 15 Minutes Revaclear: p =0.216, t-test, 2 sided
% Change in C5a at 15 Minutes Optiflux vs %Change in C5a at 15 Minutes ELISIO: p =0.216, t-test, 2 sided
% Change in C5a at 15 Minutes Revaclear vs %Change in C5a at 15 Minutes ELISIO: p =0.952, t-test, 2 sided

Primary outcome: Hemocompatibility as Shown by Thrombin/Antithrombin Complex for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers.

Time frame: Once a week during the second of the three weekly sessions specimens will be taken at the 60 and 240 minutes timepoints. Measurements for all patients were summed for each dialyzer type by time period for analysis... Mean (Standard Deviation). Unit: % Change from Baseline

Measure	Thrombin/Anti-Thrombin 60 Minutes Optiflux n = 7	Thrombin/Antithrombin 60 Minutes Revaclear n = 9	Thrombin/Antithrombin 60 Minutes ELISIO n = 6	Thrombin/Antithrombin 240 Minutes Optiflux n = 8	Thrombin/Antithrombin 240 Minutes Revaclear n = 9	Thrombin/Antithrombin 240 Minutes ELISIO n = 9
Value	35.8 (99.5)	-16.4 (44.3)	52.7 (50.4)	895.3 (755.0)	474.7 (393.9)	545.2 (573.1)

Thrombin/Anti-Thrombin 60 Minutes Optiflux vs Thrombin/Antithrombin 60 Minutes Revaclear: p =0.204, Wilcoxon (Mann-Whitney)
Thrombin/Anti-Thrombin 60 Minutes Optiflux vs Thrombin/Antithrombin 60 Minutes ELISIO: p =0.234, Wilcoxon (Mann-Whitney)
Thrombin/Antithrombin 60 Minutes Revaclear vs Thrombin/Antithrombin 60 Minutes ELISIO: p =0.015, t-test, 2 sided

Primary outcome: Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers

Time frame: Once a week during the second of three weekly sessions samples will be taken at the 0, 15, 30, 60, and 240 minute timepoints. Measurements for all patients were summed for each dialyzer type by time period for analysis.. Mean (Standard Deviation). Unit: Percent change from baseline.

Measure	Hematocrit 15 Minutes Optiflux n = 9	Hematocrit 15 Minutes Revaclear n = 10	Hematocrit 15 Minutes ELISIO n = 9	Hematocrit 30 Minutes Optiflux n = 9	Hematocrit 30 Minutes Revaclear n = 10	Hematocrit 30 Minutes ELISIO n = 9	Hematocrit 60 Minutes Optiflux n = 9	Hematocrit 60 Minutes Revaclear n = 10	Hematocrit 60 Minutes ELISIO n = 9	Hematocrit 240 Minutes Optiflux n = 9	Hematocrit 240 Minutes Revaclear n = 10	Hematocrit 240 Minutes ELISIO n = 9
Value	-5.8 (6.2)	-3.2 (6.1)	-4.2 (4.4)	-3.8 (3.7)	-2.1 (5.3)	-1.0 (5.6)	-1.8 (4.0)	-3.0 (6.7)	0.03 (5.6)	0.8 (7.0)	1.9 (6.5)	2.0 (8.3)

Hematocrit 15 Minutes Optiflux vs Hematocrit 15 Minutes Revaclear: p =0.376, t-test, 2 sided
Hematocrit 15 Minutes Optiflux vs Hematocrit 15 Minutes ELISIO: p = 1.000, Wilcoxon (Mann-Whitney)
Hematocrit 15 Minutes Revaclear vs Hematocrit 15 Minutes ELISIO: p = 0.713, Wilcoxon (Mann-Whitney)

Adverse events

Time frame: Participant was monitored continuously each of the three dialysis sessions per week over the three week study period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental: ELISIO	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Experimental: Revaclear	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Experimental: Optiflux	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Madhukar Misra, MD principal investigator

University of Missouri-Columbia

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-15H, Revaclear and Optiflux in people with End Stage Renal Disease (ESRD), run by University of Missouri-Columbia 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 8 inclusion and 7 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 5 Aug 2022. 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 5 Aug 2022). 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?

Clearance and Solute Removal Characteristics of Dialyzers (time frame: During each of the three weekly dialysis sessions measurements of urea were made at the 60 minute time point for each patient in the study. At the end of the study all measurements were summed for each of the three dialyzers.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02433210.

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 5 Aug 2022.