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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Patient Requiring Heparin Free Dialysis Treatments
• Intervention / Treatment: Device: Dialyzer with Endexo

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • New Bern, North Carolina, United States, 28560
      • Fresenius Kidney Care Craven County Dialysis Center
    • New Bern, North Carolina, United States, 28560
      • New Bern Dialysis Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence AB: circuit A follow by circuit B; 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; 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)
Experimental: Sequence BA: circuit B follow by circuit A; 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; 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)

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Percentage of Dialyzers and Blood Lines for Each Clotting Grade Using the Visual Inspection Clotting Grade Scale	Number and percentage of dialyzers (arterial end cap, venous end cap) and blood lines (CombiSet: Arterial chamber, venous chamber; Streamline: Arterial pod, venous pod, venous chamber) for each clotting grade using the visual inspection clotting grade scale	Approximately 5 weeks
HD Treatment Duration or Time to Complete Circuit Occlusion (Grade 4)	HD treatment duration or time to complete circuit occlusion (Grade 4). The treatment duration was recorded for each HD session.	Approximately 4.5 hours
Blood Volume Processed for Heparin Free	Blood volume processed (BVP) for each of 3 heparin free HD sessions (expected). The average of BVPs for each subject was calculated first then the descriptive stat. were derived.	Approximately 4.5 hours for each HD session
The Volume of Saline Administered Per Subject Per HD Session (Other Than for Circuit Priming or Rinse Back).	The volume of saline administered per subject per HD session (other than for circuit priming or rinse back). The total volume was calculated for each HD session.	Approximately 4.5 hours
The Time of Saline Administered Per Subject Per HD Session (Other Than for Circuit Priming or Rinse Back).	The time of saline administered per subject per HD session (other than for circuit priming or rinse back) during a HD session.	Approximately 4.5 hours
The Reason for Saline Administration Per Subject Per HD Session (Other Than for Circuit Priming or Rinse Back).	to determine if a HD was successful. When saline was used for maintaining blood flow or treating clotting, the heparin free HD was not successful.	Approximately 4.5 hours
Urea Reduction Ratio (URR) for All HD Sessions	to assess the adequacy of each dialysis session	Approximately 5 weeks
spKt/V for All HD Sessions	to assess the dialysis adequacy of each HD session	2 weeks for each period

Collaborators and Investigators

• Sponsor: Fresenius Medical Care North America

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): May 21, 2021
• Study Completion (Actual): June 16, 2021

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: Endexo-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes