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

NCT04511338 | Completed Results FDA Device

• 1 other identifier: Endexo-002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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: 1. Absence of complete HD circuit occlusion (Grade 4) rendering dialysis impossible 2. Absence of the need to replace dialyzers or bloodlines due to clotting 3. Absence of saline flushes to maintain blood flow through the circuit during the HD session 4. Absence of any additional heparin beyond what is allowed per study visits 5. 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 Outcomes (2)

• The Secondary Endpoints Include Adverse Events .

  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.

  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 (8)

• Number and Percentage of Dialyzers and Blood Lines 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)

  Approximately 4.5 hours

• Blood Volume Processed for Heparin Free

  Approximately 4.5 hours for each HD session

Study Arms (2)

Sequence AB: circuit A follow by circuit B

EXPERIMENTAL

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 BA: circuit B follow by circuit A

EXPERIMENTAL

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

Interventions

Dialyzer with Endexo 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 AB: circuit A follow by circuit B; Sequence BA: circuit B follow by circuit A

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fresenius Medical Care North America: lead

Study Sites (2)

Fresenius Kidney Care Craven County Dialysis Center

New Bern, North Carolina, 28560, United States

Location

New Bern Dialysis Unit

New Bern, North Carolina, 28560, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Director of Statistics and Data Management
• Organization: Fresenius Medical Care North America

chianghong.ho@fmc-na.com

1-781-249-8216

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 13, 2020
• Study Start: November 2, 2020
• Primary Completion: May 21, 2021
• Study Completion: June 16, 2021
• Last Updated: March 4, 2022
• Results First Posted: March 4, 2022

Record last verified: 2022-01

Locations

US (2)