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

NCT ID: NCT04511338

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2021-06-16

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.

Conditions

Chronic Kidney Diseases; Patient Requiring Heparin Free Dialysis Treatments

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Dialyzer with Endexo

Intervention Type: DEVICE

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)

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

Group Type: EXPERIMENTAL

Dialyzer with Endexo

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Medical Care North America

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fresenius Kidney Care Craven County Dialysis Center

New Bern, North Carolina, United States

New Bern Dialysis Unit

New Bern, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Endexo-002

Identifier Type: -

Identifier Source: org_study_id