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Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexo™ | Clinical Trials | Clareo Health

COMPLETEDNA

Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexo™

A Randomized, Open Label, Cross-over Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexo™ in End-Stage Renal Disease (ESRD) Subjects

NCT04511338•Fresenius Medical Care North America

View on ClinicalTrials.gov

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.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Must be an adult, defined as having had a 22nd birthday on or before the date of signed informed consent
•2. Has been prescribed in center thrice weekly HD for at least 180 days prior to the date of signed informed consent
•3. 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.
•4. Has a prescribed HD treatment duration ≥ 180 minutes (3 hours) and ≤ 270 minutes (4.5 hours) at the time of signed informed consent
•5. Has a well-established functional permanent vascular access (AVF, AVG) that can allow a blood flow of at least 250 mL/min
•6. 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
•7. Has the following most recently available laboratory results within 45 days prior to the date of signed informed consent:
•1. Single pool Kt/V (spKt/V) ≥ 1.2
•2. Hemoglobin ≥ 9 g/dL
•3. Platelet count ≥ 100,000/mm3
+1 more criteria

Exclusion Criteria

•1. Known allergic reactions to Endexo
•2. Known heparin contraindications
•3. Hospitalization within 30 days prior to the date of signed informed consent
•4. 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
•5. Is receiving or has received chemotherapy/radiation therapy/immunotherapy/plasmapheresis therapy within 90 days prior to the date of signed informed consent
•6. 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
•7. Is currently enrolled in or has completed any other investigational product study within 30 days prior to the date of signed informed consent
•8. Is receiving anticoagulants including vitamin K antagonists
•9. Is receiving a glycoprotein platelet inhibitor
•10. Is receiving more than one anti-platelet medication
+4 more criteria

Locations (2)

Fresenius Kidney Care Craven County Dialysis Center

New Bern, North Carolina, United States

New Bern Dialysis Unit

New Bern, North Carolina, United States

Key Dates

Start Date

November 2, 2020

Primary Completion Date

May 21, 2021

Completion Date

June 16, 2021

Last Updated

March 4, 2022

Enrollment

ACTUAL participants

Conditions

Chronic Kidney DiseasesPatient Requiring Heparin Free Dialysis Treatments

Interventions

Dialyzer with Endexo

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexo™

Inclusion Criteria

Exclusion Criteria

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