Clinical Study to Assess the Performance of the Dialyzer With Endexo™

NCT ID: NCT03536663

Last Updated: 2020-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-29
• Study Completion Date: 2019-06-17

Brief Summary

Endexo™ is an additive that is blended into the fiber solution during manufacturing of the hemodialyzer hollow fibers. The intended purpose of the additive is to increase blood compatibility in the finished dialyzer, which is referred to as the "dialyzer with Endexo."

Detailed Description

This is a prospective, sequential, multi-center, open-label study with subjects on thrice-weekly (in-center) hemodialysis (HD). After a Screening Period, there will be 12 hemodialysis treatments on the Optiflux dialyzer (Optiflux Period), followed by 38 HD treatments on the dialyzer with Endexo (Endexo Period), and then a Follow-up Visit. The study population will consist of End-Stage Renal Disease ESRD subjects who are a minimum of 22 years of age. The primary objective of the study is to collect data on the performance of the dialyzer with Endexo when used to perform hemodialysis (HD) in End-Stage Renal Disease (ESRD) subjects.

Conditions

Kidney Failure, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Optiflux/Endexo

Optiflux (Active Comparator); Hemodialysis treatments on the Optiflux dialyzer (Optiflux Period) for 4 weeks - Visit 1 to 12 Endexo (Experimental); Subjects continue on Dialyzer with Endexo (Endexo Period) for 13 weeks - Visit 13 to visit 50

Group Type: OTHER

Optiflux and Dialyzer with Endexo

Intervention Type: DEVICE

Hemodialysis (HD) on Optiflux dialyzer from Visit 1 to 12 and followed by HD on the dialyzer with Endexo at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 17 weeks.

Interventions

Optiflux and Dialyzer with Endexo

Hemodialysis (HD) on Optiflux dialyzer from Visit 1 to 12 and followed by HD on the dialyzer with Endexo at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 17 weeks.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Must be an adult, older than 22 years of age.

2. Has been prescribed in-center thrice-weekly HD continuously for at least 180 days prior to the date of signed informed consent

3. Has been prescribed the Optiflux F160NR dialyzer continuously for at least 30 days prior to the date of signed informed consent

4. Has a prescribed HD treatment time ≥180 minutes (3 hours) and ≤270 minutes (4.5 hours)

5. Has been on heparin anticoagulation for dialysis and has had no change in heparin prescription within 14 days prior to the date of signed informed consent

6. Has a most recent single pool Kt/V (spKt/V) ≥1.2 within 45 days prior to the date of a signed informed consent

7. Has a most recent hemoglobin ≥9 g/dL within 45 days prior to the date of a signed informed consent

8. Has a most recent platelet count ≥100,000/mm3 within 45 days prior to the date of a signed informed consent

9. 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. Use of citric acid concentrate (such as Citrasate®) at the time of signed informed consent

2. Known allergic reactions to Endexo

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, or liver cirrhosis

5. Are receiving or have received chemotherapy / radiation therapy / plasmapheresis therapy within 90 days prior to the date of signed informed consent

6. Are receiving antibiotics or have used antibiotics within 14 days prior to the date of signed informed consent

7. Are currently enrolled in or have completed any other investigational product study within 30 days prior to the date of signed informed consent

8. Has a life expectancy of less than 1 year

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Medical Care North America

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shakil Aslam, MD

Role: STUDY_DIRECTOR

Fresenius Medical Care RTG, LLC

Dylan Steer, MD

Role: PRINCIPAL_INVESTIGATOR

California Institute of Renal Research

Lisa Weber, MD

Role: PRINCIPAL_INVESTIGATOR

Research Management Inc/ Kansas Nephrology Research Institute, LLC-J/V

Jill Meyer, MD

Role: PRINCIPAL_INVESTIGATOR

Balboa Nephrology Med Group

Locations

Balboa Nephrology Med Group

Chula Vista, California, United States

California Institute of Renal Research

San Diego, California, United States

Research Management Inc/ Kansas Nephrology Research Institute, LLC-J/V

Wichita, Kansas, United States

Countries

United States

References

Meyer JM, Steer D, Weber LA, Zeitone AA, Thakuria M, Ho CH, Aslam S, Mullon C, Kossmann RJ. Safety of a Novel Dialyzer Containing a Fluorinated Polyurethane Surface-Modifying Macromolecule in Patients with End-Stage Kidney Disease. Blood Purif. 2021;50(6):959-967. doi: 10.1159/000514937. Epub 2021 Mar 31.

Reference Type: DERIVED

PMID: 33789265 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

Endexo-001

Identifier Type: -

Identifier Source: org_study_id