Kidney Failure, ChronicNCT03536663
Clinical Study to Assess the Performance of the Dialyzer With Endexo™
A study testing Optiflux and Dialyzer with Endexo in people with Kidney Failure, Chronic, run by Fresenius Medical Care North America at 3 sites in United States.
Trial summary
Endexo™ is an additive that is blended into the fiber solution during manufacturing of the hemodialyzer hollow fibers. The intended purpose of the additive is to increase blood compatibility in the finished dialyzer, which is referred to as the "dialyzer with Endexo." Read more about this study
- Who is it for?
- Ages 22 to 99 years
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Optiflux and Dialyzer with Endexo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Aug 2018to 17 Jun 2019
- 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 22 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be an adult, older than 22 years of age.
- Has been prescribed in-center thrice-weekly HD continuously for at least 180 days prior to the date of signed informed consent
- Has been prescribed the Optiflux F160NR dialyzer continuously for at least 30 days prior to the date of signed informed consent
- Has a prescribed HD treatment time ≥180 minutes (3 hours) and ≤270 minutes (4.5 hours)
- Has been on heparin anticoagulation for dialysis and has had no change in heparin prescription within 14 days prior to the date of signed informed consent
- Has a most recent single pool Kt/V (spKt/V) ≥1.2 within 45 days prior to the date of a signed informed consent
Show all 9Show fewer
- Has a most recent hemoglobin ≥9 g/dL within 45 days prior to the date of a signed informed consent
- Has a most recent platelet count ≥100,000/mm3 within 45 days prior to the date of a signed informed consent
- A female of childbearing potential must have a negative serum pregnancy test at the time of screening and agree to use an acceptable method of contraception during the study
Who cannot join
- Use of citric acid concentrate (such as Citrasate®) at the time of signed informed consent
- Known allergic reactions to Endexo
- Hospitalization within 30 days prior to the date of signed informed consent
- Presence of active malignancy, congestive heart failure New York Heart Association (NYHA) Class III or IV, or liver cirrhosis
- Are receiving or have received chemotherapy / radiation therapy / plasmapheresis therapy within 90 days prior to the date of signed informed consent
- Are receiving antibiotics or have used antibiotics within 14 days prior to the date of signed informed consent
- Are currently enrolled in or have completed any other investigational product study within 30 days prior to the date of signed informed consent
- Has a life expectancy of less than 1 year
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Balboa Nephrology Med Group
Chula Vista, California, 92154
California Institute of Renal Research
San Diego, California, 92111
Research Management Inc/ Kansas Nephrology Research Institute, LLC-J/V
Wichita, Kansas, 67214
About this study
Official title: An Open-Label Clinical Study to Assess the Performance of the Dialyzer With Endexo™ in End-Stage Renal Disease Subjects
Endexo™ is an additive that is blended into the fiber solution during manufacturing of the hemodialyzer hollow fibers. The intended purpose of the additive is to increase blood compatibility in the finished dialyzer, which is referred to as the "dialyzer with Endexo."
Read the detailed description
This is a prospective, sequential, multi-center, open-label study with subjects on thrice-weekly (in-center) hemodialysis (HD). After a Screening Period, there will be 12 hemodialysis treatments on the Optiflux dialyzer (Optiflux Period), followed by 38 HD treatments on the dialyzer with Endexo (Endexo Period), and then a Follow-up Visit. The study population will consist of End-Stage Renal Disease ESRD subjects who are a minimum of 22 years of age. The primary objective of the study is to collect data on the performance of the dialyzer with Endexo when used to perform hemodialysis (HD) in End-Stage Renal Disease (ESRD) subjects.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Optiflux and Dialyzer with Endexo
- 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.
Optiflux and Dialyzer with EndexoDevice
Hemodialysis (HD) on Optiflux dialyzer from Visit 1 to 12 and followed by HD on the dialyzer with Endexo at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 17 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Optiflux/Endexo | Other | Optiflux (Active Comparator); Hemodialysis treatments on the Optiflux dialyzer (Optiflux Period) for 4 weeks - Visit 1 to 12 Endexo (Experimental); Subjects continue on Dialyzer with Endexo (Endexo Period) for 13 weeks - Visit 13 to visit 50 Receives: Device: Optiflux and Dialyzer with Endexo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the Dialyzer With Endexo by Measuring Its in Vivo Ultrafiltration Coefficient
Ultrafiltration coefficient (Kuf) is the ratio of ultrafiltration rate in ml/hr to the Transmembrane pressure in mmHg. Both the Ultrafiltration rate and the transmembrane pressure readings are collected from the machine.
Measured: 15 minutes after the recorded start of hemodialysis with Endexo upon its first use in the study
Secondary outcomes (5)
The Number of Any Adverse Events
All adverse events were captured from subject enrollment to the completion of Optiflux period, and to the end of study or withdraws from the study.
Measured: Optiflux: from enrollment, weeks 1 to 4 (visits 1 to 12); Endexo: from weeks 5 to 17, and follow-up, a total of 17 weeks intervention.
The Number of Any Device-related Adverse Events
Any device-related adverse events were captured from subject enrollment to the completion of Optiflux period, and to the end of study or withdraws from the study.
Measured: Optiflux: from enrollment, weeks 1 to 4 (visits 1 to 12); Endexo: from weeks 5 to 17, and follow-up, a total of 17 weeks intervention.
Removal of Urea
- URR = (pre-HD urea - post-HD urea)/pre-HD urea * 100
- Data across visits were averaged for each subject, and then a group mean and sd were calculated.
Measured: At visits 1/week 1, 10/week 4, 13/week 5, 22/week 8, 34/week 12, and 46/week 16
Removal of Albumin
%change = (post-HD - pre-HD)/pre-HD * 100
Measured: Pre- and Post- HD at Visits 1/week 1, 13/week 5
Removal of Beta-2-microglobulin
% reduction = (post-HD - pre-HD)/pre-HD * 100 with post-HD B2M adjusted to pre- and post HD weights
Measured: Pre- and Post- HD at Visits 1/week 1, 13/week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start29 Aug 2018
- Primary completion17 Apr 2019
- Study completion17 Jun 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies 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
- Sequential
- Model description
- 12 HD treatments (4 weeks) with Optiflux dialyzer followed by 38 HD treatments (13 weeks) with Endexo dialyzer
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care North America
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shakil Aslam, MD, Study director, Fresenius Medical Care RTG, LLCDylan Steer, MD, Principal investigator, California Institute of Renal ResearchLisa Weber, MD, Principal investigator, Research Management Inc/ Kansas Nephrology Research Institute, LLC-J/VJill Meyer, MD, Principal investigator, Balboa Nephrology Med Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536663
- Sponsor's protocol ID
- Endexo-001
- Status last verified
- Nov 2020
- First submitted
- 6 Apr 2018
- Last updated
- 27 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Meyer JM, Steer D, Weber LA, Zeitone AA, Thakuria M, Ho CH, Aslam S, Mullon C, Kossmann RJ. Safety of a Novel Dialyzer Containing a Fluorinated Polyurethane Surface-Modifying Macromolecule in Patients with End-Stage Kidney Disease. Blood Purif. 2021;50(6):959-967. doi: 10.1159/000514937. Epub 2021 Mar 31.
PubMed 33789265
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Clinical Study to Assess the Performance of the Dialyzer With Endexo™ in End-Stage Renal Disease Subjects
- ClinicalTrials.gov ID
- NCT03536663
- Acronym / sponsor ID
- Endexo-001
- Conditions
- Kidney Failure, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Fresenius Medical Care North AmericaIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 17 Jun 2019 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Posted 12 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endexo™ is an additive that is blended into the fiber solution during manufacturing of the hemodialyzer hollow fibers. The intended purpose of the additive is to increase blood compatibility in the finished dialyzer, which is referred to as the "dialyzer with Endexo."
Detailed description
This is a prospective, sequential, multi-center, open-label study with subjects on thrice-weekly (in-center) hemodialysis (HD). After a Screening Period, there will be 12 hemodialysis treatments on the Optiflux dialyzer (Optiflux Period), followed by 38 HD treatments on the dialyzer with Endexo (Endexo Period), and then a Follow-up Visit. The study population will consist of End-Stage Renal Disease ESRD subjects who are a minimum of 22 years of age. The primary objective of the study is to collect data on the performance of the dialyzer with Endexo when used to perform hemodialysis (HD) in End-Stage Renal Disease (ESRD) subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 12 HD treatments (4 weeks) with Optiflux dialyzer followed by 38 HD treatments (13 weeks) with Endexo dialyzer
| Arm | Type | Receives |
|---|---|---|
| Optiflux/Endexo | Other | Device: Optiflux and Dialyzer with EndexoOptiflux (Active Comparator); Hemodialysis treatments on the Optiflux dialyzer (Optiflux Period) for 4 weeks - Visit 1 to 12 Endexo (Experimental); Subjects continue on Dialyzer with Endexo (Endexo Period) for 13 weeks - Visit 13 to visit 50 |
Who may qualify
- Ages
- 22 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must be an adult, older than 22 years of age.
- Has been prescribed in-center thrice-weekly HD continuously for at least 180 days prior to the date of signed informed consent
- Has been prescribed the Optiflux F160NR dialyzer continuously for at least 30 days prior to the date of signed informed consent
- Has a prescribed HD treatment time ≥180 minutes (3 hours) and ≤270 minutes (4.5 hours)
- Has been on heparin anticoagulation for dialysis and has had no change in heparin prescription within 14 days prior to the date of signed informed consent
Key exclusion criteria (8 listed)
- Use of citric acid concentrate (such as Citrasate®) at the time of signed informed consent
- Known allergic reactions to Endexo
- Hospitalization within 30 days prior to the date of signed informed consent
- Presence of active malignancy, congestive heart failure New York Heart Association (NYHA) Class III or IV, or liver cirrhosis
- Are receiving or have received chemotherapy / radiation therapy / plasmapheresis therapy within 90 days prior to the date of signed informed consent
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 |
|---|---|---|
| Optiflux and Dialyzer with EndexoHemodialysis (HD) on Optiflux dialyzer from Visit 1 to 12 and followed by HD on the dialyzer with Endexo at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 17 weeks. | Device | Optiflux/Endexo |
Primary outcome
Performance of the Dialyzer With Endexo by Measuring Its in Vivo Ultrafiltration Coefficient
Time frame: 15 minutes after the recorded start of hemodialysis with Endexo upon its first use in the study
Ultrafiltration coefficient (Kuf) is the ratio of ultrafiltration rate in ml/hr to the Transmembrane pressure in mmHg. Both the Ultrafiltration rate and the transmembrane pressure readings are collected from the machine.
5 secondary outcomes
The Number of Any Adverse Events
Time frame: Optiflux: from enrollment, weeks 1 to 4 (visits 1 to 12); Endexo: from weeks 5 to 17, and follow-up, a total of 17 weeks intervention.
The Number of Any Device-related Adverse Events
Time frame: Optiflux: from enrollment, weeks 1 to 4 (visits 1 to 12); Endexo: from weeks 5 to 17, and follow-up, a total of 17 weeks intervention.
Removal of Urea
Time frame: At visits 1/week 1, 10/week 4, 13/week 5, 22/week 8, 34/week 12, and 46/week 16
Removal of Albumin
Time frame: Pre- and Post- HD at Visits 1/week 1, 13/week 5
Removal of Beta-2-microglobulin
Time frame: Pre- and Post- HD at Visits 1/week 1, 13/week 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33789265Meyer JM, Steer D, Weber LA, Zeitone AA, Thakuria M, Ho CH, Aslam S, Mullon C, Kossmann RJ. Safety of a Novel Dialyzer Containing a Fluorinated Polyurethane Surface-Modifying Macromolecule in Patients with End-Stage Kidney Disease. Blood Purif. 2021;50(6):959-967. doi: 10.1159/000514937. Epub 2021 Mar 31.
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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.
Shakil Aslam, MD study director
Fresenius Medical Care RTG, LLC
Dylan Steer, MD principal investigator
California Institute of Renal Research
Lisa Weber, MD principal investigator
Research Management Inc/ Kansas Nephrology Research Institute, LLC-J/V
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optiflux and Dialyzer with Endexo in people with Kidney Failure, Chronic, run by Fresenius Medical Care North America at 3 sites 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 9 inclusion and 8 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 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 12 Nov 2020). 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?
Performance of the Dialyzer With Endexo by Measuring Its in Vivo Ultrafiltration Coefficient (time frame: 15 minutes after the recorded start of hemodialysis with Endexo upon its first use in the study). 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 NCT03536663, which also lists 1 linked publication.
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 27 Nov 2020.