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

An Open-Label Clinical Study to Assess the Performance of the Dialyzer With Endexo™ in End-Stage Renal Disease Subjects

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."

Study Overview

• Status: Completed
• Conditions: Kidney Failure, Chronic
• Intervention / Treatment: Device: Optiflux and 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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 92154
      • Balboa Nephrology Med Group
    • San Diego, California, United States, 92111
      • California Institute of Renal Research
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Research Management Inc/ Kansas Nephrology Research Institute, LLC-J/V

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of the Dialyzer With Endexo by Measuring Its in Vivo Ultrafiltration Coefficient	Ultrafiltration coefficient (Kuf) is the ratio of ultrafiltration rate in ml/hr to the Transmembrane pressure in mmHg. Both the Ultrafiltration rate and the transmembrane pressure readings are collected from the machine.	15 minutes after the recorded start of hemodialysis with Endexo upon its first use in the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Any Adverse Events	All adverse events were captured from subject enrollment to the completion of Optiflux period, and to the end of study or withdraws from the study.	Optiflux: from enrollment, weeks 1 to 4 (visits 1 to 12); Endexo: from weeks 5 to 17, and follow-up, a total of 17 weeks intervention.
The Number of Any Device-related Adverse Events	Any device-related adverse events were captured from subject enrollment to the completion of Optiflux period, and to the end of study or withdraws from the study.	Optiflux: from enrollment, weeks 1 to 4 (visits 1 to 12); Endexo: from weeks 5 to 17, and follow-up, a total of 17 weeks intervention.
Removal of Urea	URR = (pre-HD urea - post-HD urea)/pre-HD urea * 100; Data across visits were averaged for each subject, and then a group mean and sd were calculated.	At visits 1/week 1, 10/week 4, 13/week 5, 22/week 8, 34/week 12, and 46/week 16
Removal of Albumin	%change = (post-HD - pre-HD)/pre-HD * 100	Pre- and Post- HD at Visits 1/week 1, 13/week 5
Removal of Beta-2-microglobulin	% reduction = (post-HD - pre-HD)/pre-HD * 100 with post-HD B2M adjusted to pre- and post HD weights	Pre- and Post- HD at Visits 1/week 1, 13/week 5

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dialyzer Hemocompatibility	The dialyzer hemo-compatibility is measured by measuring the activation of the complement system (C3a, C5a, SC5b-9)	Assessed at the first time the dialyzers are used in the study , collected pre hemodialysis and 30 minutes after the recorded start of hemodialysis
Clotting of the Dialyzer	Thrombus scoring will be assessed according to a clotting scale (The graded scoring method)	visual evaluation of the dialyzer arterial cap will be performed at the end of every hemodialysis treatment to determine the Grade:1,2,3 or 4. (1:no clotting to 4: total clotting), throughout a total of 17 weeks intervention.

Collaborators and Investigators

• Sponsor: Fresenius Medical Care North America
• Investigators: Study Director: Shakil Aslam, MD, Fresenius Medical Care RTG, LLC; Principal Investigator: Dylan Steer, MD, California Institute of Renal Research; Principal Investigator: Lisa Weber, MD, Research Management Inc/ Kansas Nephrology Research Institute, LLC-J/V; Principal Investigator: Jill Meyer, MD, Balboa Nephrology Med Group

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2018
• Primary Completion (Actual): April 17, 2019
• Study Completion (Actual): June 17, 2019

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 25, 2018

Study Record Updates

• Last Update Posted (Actual): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 13, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: Endexo-001

Drug and device information, study documents

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