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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Kidney Diseases, Patient Requiring Heparin Free Dialysis Treatments

Intervention / Treatment
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* Device: Dialyzer with Endexo


Participation Criteria
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Eligibility Criteria
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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 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence AB: circuit A follow by circuit B<br>Circuit (A) includes the dialyzer with Endexo and the CombiSet bloodline Circuit (B) includes dialyzer with Endexo and the Streamline bloodline | Device: Dialyzer with Endexo<br>* 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)<br>|
| Experimental: Sequence BA: circuit B follow by circuit A<br>Circuit (B) includes dialyzer with Endexo and the Streamline bloodline Circuit (A) includes the dialyzer with Endexo and the CombiSet bloodline | Device: Dialyzer with Endexo<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Secondary Endpoints Include Adverse Events . | The number of Serious Adverse Events and Adverse Events during the study periods | 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 | 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) |