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

Not Applicable

Completed

• Conditions: Kidney Failure, Chronic
• Interventions: Device: Optiflux and Dialyzer with Endexo

• Registration Number: NCT03536663
• Lead Sponsor: Fresenius Medical Care North America

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.

Study Timeline

• Study First Submitted: 2018-04-06
• Study First Submitted QC: 2018-05-14
• Study First Posted: 2018-05-25
• Study Start: 2018-08-29
• Primary Completion: 2019-04-17
• Study Completion: 2019-06-17
• Results First Submitted: 2020-08-17
• Results First Submitted QC: 2020-10-20
• Status Verified: 2020-11
• Results First Posted: 2020-11-12
• Last Update Submitted: 2020-11-13
• Last Update Posted: 2020-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Optiflux/Endexo	Optiflux and Dialyzer with 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

Primary Outcome Measures

Name	Time	Method
Performance of the Dialyzer With Endexo by Measuring Its in Vivo Ultrafiltration Coefficient	15 minutes after the recorded start of hemodialysis with Endexo upon its first use in the study	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.

Secondary Outcome Measures

Name	Time	Method
The Number of Any Adverse Events	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.	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.
Removal of Albumin	Pre- and Post- HD at Visits 1/week 1, 13/week 5	%change = (post-HD - pre-HD)/pre-HD \* 100
The Number of Any Device-related Adverse Events	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.	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.
Removal of Urea	At visits 1/week 1, 10/week 4, 13/week 5, 22/week 8, 34/week 12, and 46/week 16	1. URR = (pre-HD urea - post-HD urea)/pre-HD urea \* 100; 2. Data across visits were averaged for each subject, and then a group mean and sd were calculated.
Removal of Beta-2-microglobulin	Pre- and Post- HD at Visits 1/week 1, 13/week 5	% reduction = (post-HD - pre-HD)/pre-HD \* 100 with post-HD B2M adjusted to pre- and post HD weights

Trial Locations

Locations (3)

California Institute of Renal Research; 🇺🇸 San Diego, California, United States

Balboa Nephrology Med Group; 🇺🇸 Chula Vista, California, United States

Research Management Inc/ Kansas Nephrology Research Institute, LLC-J/V; 🇺🇸 Wichita, Kansas, United States