Clinical trial NCT04511338: Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexo™
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Patient Requiring Heparin Free Dialysis Treatments
Lead sponsor: Fresenius Medical Care North America
Sponsor class: INDUSTRY
First posted: 2020-08-13
Enrollment: 16
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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 criteria: 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
8. 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

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
11. Is receiving systemic heparin therapy for prevention or treatment besides heparin prescribed for dialysis
12. Requiring blood and other labile blood products (for e.g., fresh frozen plasma, platelets) transfusion during HD treatments
13. Has history of clotting or bleeding disorders
14. 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.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: The Secondary Endpoints Include Adverse Events .
timeFrame: 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)
measure: The Secondary Endpoints Include Device-related Adverse Events.
timeFrame: 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)
Other outcomes:
measure: Number and Percentage of Dialyzers and Blood Lines for Each Clotting Grade Using the Visual Inspection Clotting Grade Scale
timeFrame: Approximately 5 weeks
measure: HD Treatment Duration or Time to Complete Circuit Occlusion (Grade 4)
timeFrame: Approximately 4.5 hours
measure: Blood Volume Processed for Heparin Free
timeFrame: Approximately 4.5 hours for each HD session
measure: The Volume of Saline Administered Per Subject Per HD Session (Other Than for Circuit Priming or Rinse Back).
timeFrame: Approximately 4.5 hours
measure: The Time of Saline Administered Per Subject Per HD Session (Other Than for Circuit Priming or Rinse Back).
timeFrame: Approximately 4.5 hours
measure: The Reason for Saline Administration Per Subject Per HD Session (Other Than for Circuit Priming or Rinse Back).
timeFrame: Approximately 4.5 hours
measure: Urea Reduction Ratio (URR) for All HD Sessions
timeFrame: Approximately 5 weeks
measure: spKt/V for All HD Sessions
timeFrame: 2 weeks for each period
Locations:
city: New Bern
country: United States
facility: Fresenius Kidney Care Craven County Dialysis Center
state: North Carolina
city: New Bern
country: United States
facility: New Bern Dialysis Unit
state: North Carolina
Study officials:
References: