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

Sponsors

Lead Sponsor: Fresenius Medical Care North America

Source Fresenius Medical Care North America
Brief Summary

This study will assess the safety and efficacy of heparin free HD performed with dialyzers with Endexo in adult end-stage renal disease (ESRD) subjects on thrice-weekly in-center HD.

Overall Status Not yet recruiting
Start Date September 21, 2020
Completion Date May 14, 2021
Primary Completion Date April 2, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The primary endpoint is the number and percent (%) of successful heparin-free HD sessions* for each subject in each circuit. Approximately 5 weeks
Secondary Outcome
Measure Time Frame
The secondary endpoints include adverse events . Approximately 10 weeks
The secondary endpoints include device-related adverse events. Approximately 10 weeks
Enrollment 16
Condition
Intervention

Intervention Type: Device

Intervention Name: Dialyzer with Endexo

Description: 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)

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), 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.

Gender: All

Minimum Age: 22 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Insil Kim, Ph. D

Phone: 351-666-9499

Email: [email protected]

Location
Facility: Contact: Investigator:
Fresenius Kidney Care Craven County Dialysis Center | New Bern, North Carolina, 28560, United States 800-881-5101 Manuel Montero, MD Principal Investigator
New Bern Dialysis Unit | New Bern, North Carolina, 28560, United States 252-633-6303 Manuel Montero, MD Principal Investigator
Location Countries

United States

Verification Date

August 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Circuit A

Type: Experimental

Description: Circuit (A) includes the dialyzer with Endexo and the CombiSet bloodline

Label: Circuit B

Type: Experimental

Description: Circuit (B) includes dialyzer with Endexo and the Streamline bloodline

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov