Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexoâ„¢ (NCT04511338) | Clinical Trial Compass
CompletedNot Applicable
Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexoâ„¢
United States16 participantsStarted 2020-11-02
Plain-language 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.
Who can participate
Age range22 Years
SexALL
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Inclusion criteria
✓. 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
✓. 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
Exclusion criteria
✕. Known allergic reactions to Endexo
✕. Known heparin contraindications
✕. Hospitalization within 30 days prior to the date of signed informed consent
What they're measuring
1
The Primary Endpoint is the Number and Percent (%) of Successful Heparin-free HD Sessions for Each Subject in Each Circuit.
Timeframe: 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.
. 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
✕. 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