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

Completed · Not applicable

Conditions studied: Chronic Kidney Diseases, Patient Requiring Heparin Free Dialysis Treatments

In brief

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.

Key facts

Study ID

NCT04511338

Run by

Fresenius Medical Care North America

People needed

16

Starts

2020-11-02

Expected to finish

2021-06-16

Last updated by the study team

2022-03-04

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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
• 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.

Where it is running

• Fresenius Kidney Care Craven County Dialysis Center — New Bern, North Carolina, United States
• New Bern Dialysis Unit — New Bern, North Carolina, United States

Full record on ClinicalTrials.gov

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