Chronic Kidney DiseasesNCT04511338
Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexo™
A study testing Dialyzer with Endexo in people with Chronic Kidney Diseases and Patient Requiring Heparin Free Dialysis Treatments, run by Fresenius Medical Care North America at 2 sites in United States.
Trial summary
This study will assess the safety and efficacy of heparin free hemodialysis (HD) performed with dialyzers with Endexo in adult end-stage renal disease (ESRD) subjects on thrice-weekly in-center HD. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Patient Requiring Heparin Free Dialysis Treatments
- What is being tested?
- Dialyzer with Endexo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Nov 2020to 16 Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be an adult, defined as having had a 22nd birthday on or before the date of signed informed consent
- Has been prescribed in center thrice weekly HD for at least 180 days prior to the date of signed informed consent
- Has been on Conventional HD for at least 30 days prior to the date of signed informed consent. Conventional HD includes: Optiflux dialyzer (F160NR or F180NR), standard of care (SOC) bloodline, Citrasate dialysate, and regularly prescribed heparin dose.
- Has a prescribed HD treatment duration ≥ 180 minutes (3 hours) and ≤ 270 minutes (4.5 hours) at the time of signed informed consent
- Has a well-established functional permanent vascular access (AVF, AVG) that can allow a blood flow of at least 250 mL/min
- Has been on a regularly prescribed heparin dose for HD and has had no change in heparin prescription within 14 days prior to the date of signed informed consent
Show all 11Show fewer
- Has the following most recently available laboratory results within 45 days prior to the date of signed informed consent:
- Single pool Kt/V (spKt/V) ≥ 1.2
- Hemoglobin ≥ 9 g/dL
- Platelet count ≥ 100,000/mm3
- 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
- Known allergic reactions to Endexo
- Known heparin contraindications
- 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 (see Appendix II. A New York Heart Association Functional Classification), or liver cirrhosis
- Is receiving or has received chemotherapy/radiation therapy/immunotherapy/plasmapheresis therapy within 90 days prior to the date of signed informed consent
- Is receiving oral or/and intravenous (IV) antibiotics or has used oral or/and IV antibiotics within 14 days prior to the date of signed informed consent
Show all 14Show fewer
- Is currently enrolled in or has completed any other investigational product study within 30 days prior to the date of signed informed consent
- Is receiving anticoagulants including vitamin K antagonists
- Is receiving a glycoprotein platelet inhibitor
- Is receiving more than one anti-platelet medication
- Is receiving systemic heparin therapy for prevention or treatment besides heparin prescribed for dialysis
- Requiring blood and other labile blood products (for e.g., fresh frozen plasma, platelets) transfusion during HD treatments
- Has history of clotting or bleeding disorders
- Has history or current evidence of any condition, therapy, or laboratory abnormality that might interfere with the participant's ability to follow the requirements of the study and participate for the full duration of the study, or is not in the best interest of the subjects to participate, in the opinion of the investigator.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fresenius Kidney Care Craven County Dialysis Center
New Bern, North Carolina, 28560
New Bern Dialysis Unit
New Bern, North Carolina, 28560
About this study
Official title: A Randomized, Open Label, Cross-over Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexo™ in End-Stage Renal Disease (ESRD) Subjects
This study will assess the safety and efficacy of heparin free hemodialysis (HD) performed with dialyzers with Endexo in adult end-stage renal disease (ESRD) subjects on thrice-weekly in-center HD.
- Being tested
- Dialyzer with Endexo
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialyzer with EndexoDevice
Sequence AB:
Period 1 Circuit A (Five Visits: 1,2,3,4,5) Period 2 Circuit B (Five Visits: 9,10,11,12,13)
Sequence BA:
Period 1 Circuit B (Five Visits: 1,2,3,4,5) Period 2 Circuit A (Five Visits: 9,10,11,12,13)
| Study group | Role | What they receive |
|---|---|---|
| Sequence AB: circuit A follow by circuit B | Experimental | Circuit (A) includes the dialyzer with Endexo and the CombiSet bloodline Circuit (B) includes dialyzer with Endexo and the Streamline bloodline Receives: Device: Dialyzer with Endexo |
| Sequence BA: circuit B follow by circuit A | Experimental | Circuit (B) includes dialyzer with Endexo and the Streamline bloodline Circuit (A) includes the dialyzer with Endexo and the CombiSet bloodline Receives: Device: Dialyzer with Endexo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Endpoint is the Number and Percent (%) of Successful Heparin-free HD Sessions for Each Subject in Each Circuit.
Each participant was expected to receive 3 heparin-free HD sessions. The number and percentage of successful HD sessions were derived based on the 3 heparin-free HD sessions for each participant in each circuit.
A successful HD session must meet all the following criteria:
- Absence of complete HD circuit occlusion (Grade 4) rendering dialysis impossible
- Absence of the need to replace dialyzers or bloodlines due to clotting
- Absence of saline flushes to maintain blood flow through the circuit during the HD session
- Absence of any additional heparin beyond what is allowed per study visits
- Single pool Kt/V (spKt/V) ≥ 1.2
Measured: Approximately 5 weeks, Period 1: two weeks with either Circuit A or Circuit B; Washout: 1 week; Period 2: two weeks with the circuit other than Period 1.
Secondary outcomes (2)
The Secondary Endpoints Include Adverse Events .
The number of Serious Adverse Events and Adverse Events during the study periods
Measured: two weeks each period (10 weeks per subject: 4 weeks for screening, 2 weeks for Period 1, 1 week for Washout, and 2 weeks for Period 2)
The Secondary Endpoints Include Device-related Adverse Events.
All device-related serious adverse events and adverse events occurred during the study periods
Measured: two weeks each period (10 weeks per subject: 4 weeks for screening, 2 weeks for Period 1, 1 week for Washout, and 2 weeks for Period 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start2 Nov 2020
- Primary completion21 May 2021
- Study completion16 Jun 2021
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 Chronic Kidney DiseasesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care North America
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511338
- Sponsor's protocol ID
- Endexo-002
- Status last verified
- Jan 2022
- First submitted
- 7 Aug 2020
- Last updated
- 4 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Cross-over Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexo™ in End-Stage Renal Disease (ESRD) Subjects
- ClinicalTrials.gov ID
- NCT04511338
- Acronym / sponsor ID
- Endexo-002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Fresenius Medical Care North AmericaIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 16 Jun 2021 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Posted 4 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety and efficacy of heparin free hemodialysis (HD) performed with dialyzers with Endexo in adult end-stage renal disease (ESRD) subjects on thrice-weekly in-center HD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence AB: circuit A follow by circuit B | Experimental | Device: Dialyzer with EndexoCircuit (A) includes the dialyzer with Endexo and the CombiSet bloodline Circuit (B) includes dialyzer with Endexo and the Streamline bloodline |
| Sequence BA: circuit B follow by circuit A | Experimental | Device: Dialyzer with EndexoCircuit (B) includes dialyzer with Endexo and the Streamline bloodline Circuit (A) includes the dialyzer with Endexo and the CombiSet bloodline |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Must be an adult, defined as having had a 22nd birthday on or before the date of signed informed consent
- Has been prescribed in center thrice weekly HD for at least 180 days prior to the date of signed informed consent
- Has been on Conventional HD for at least 30 days prior to the date of signed informed consent. Conventional HD includes: Optiflux dialyzer (F160NR or F180NR), standard of care (SOC) bloodline, Citrasate dialysate, and regularly prescribed heparin dose.
- Has a prescribed HD treatment duration ≥ 180 minutes (3 hours) and ≤ 270 minutes (4.5 hours) at the time of signed informed consent
- Has a well-established functional permanent vascular access (AVF, AVG) that can allow a blood flow of at least 250 mL/min
Key exclusion criteria (14 listed)
- Known allergic reactions to Endexo
- Known heparin contraindications
- 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 (see Appendix II. A New York Heart Association Functional Classification), or liver cirrhosis
- Is receiving or has received chemotherapy/radiation therapy/immunotherapy/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 |
|---|---|---|
| Dialyzer with EndexoSequence AB: Period 1 Circuit A (Five Visits: 1,2,3,4,5) Period 2 Circuit B (Five Visits: 9,10,11,12,13) Sequence BA: Period 1 Circuit B (Five Visits: 1,2,3,4,5) Period 2 Circuit A (Five Visits: 9,10,11,12,13) | Device | Sequence AB: circuit A follow by circuit B, Sequence BA: circuit B follow by circuit A |
Primary outcome
The Primary Endpoint is the Number and Percent (%) of Successful Heparin-free HD Sessions for Each Subject in Each Circuit.
Time frame: Approximately 5 weeks, Period 1: two weeks with either Circuit A or Circuit B; Washout: 1 week; Period 2: two weeks with the circuit other than Period 1.
Each participant was expected to receive 3 heparin-free HD sessions. The number and percentage of successful HD sessions were derived based on the 3 heparin-free HD sessions for each participant in each circuit. A successful HD session must meet all the following criteria: 1. Absence of complete HD circuit occlusion (Grade 4) rendering dialysis impossible 2. Absence of the need to replace dialyzers or bloodlines due to clotting 3. Absence of saline flushes to maintain blood flow through the circuit during the HD session 4. Absence of any additional heparin beyond what is allowed per study visits 5. Single pool Kt/V (spKt/V) ≥ 1.2
2 secondary outcomes
The Secondary Endpoints Include Adverse Events .
Time frame: two weeks each period (10 weeks per subject: 4 weeks for screening, 2 weeks for Period 1, 1 week for Washout, and 2 weeks for Period 2)
The Secondary Endpoints Include Device-related Adverse Events.
Time frame: two weeks each period (10 weeks per subject: 4 weeks for screening, 2 weeks for Period 1, 1 week for Washout, and 2 weeks for Period 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chronic Kidney Diseases
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialyzer with Endexo in people with Chronic Kidney Diseases and Patient Requiring Heparin Free Dialysis Treatments, run by Fresenius Medical Care North America at 2 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 11 inclusion and 14 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 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 4 Mar 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?
The Primary Endpoint is the Number and Percent (%) of Successful Heparin-free HD Sessions for Each Subject in Each Circuit. (time frame: Approximately 5 weeks, Period 1: two weeks with either Circuit A or Circuit B; Washout: 1 week; Period 2: two weeks with the circuit other than Period 1.). 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 4 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.