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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Failure, Chronic

Intervention / Treatment
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* Device: Optiflux and Dialyzer with Endexo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be an adult, older than 22 years of age. Has been prescribed in-center thrice-weekly HD continuously for at least 180 days prior to the date of signed informed consent Has been prescribed the Optiflux F160NR dialyzer continuously for at least 30 days prior to the date of signed informed consent Has a prescribed HD treatment time ≥180 minutes (3 hours) and ≤270 minutes (4.5 hours) 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 Has a most recent single pool Kt/V (spKt/V) ≥1.2 within 45 days prior to the date of a signed informed consent Has a most recent hemoglobin ≥9 g/dL within 45 days prior to the date of a signed informed consent Has a most recent platelet count ≥100,000/mm3 within 45 days prior to the date of a signed informed consent 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: Use of citric acid concentrate (such as Citrasate®) at the time of signed informed consent Known allergic reactions to Endexo 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, or liver cirrhosis Are receiving or have received chemotherapy / radiation therapy / plasmapheresis therapy within 90 days prior to the date of signed informed consent Are receiving antibiotics or have used antibiotics within 14 days prior to the date of signed informed consent Are currently enrolled in or have completed any other investigational product study within 30 days prior to the date of signed informed consent Has a life expectancy of less than 1 year

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: 12 HD treatments (4 weeks) with Optiflux dialyzer followed by 38 HD treatments (13 weeks) with Endexo dialyzer
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Optiflux/Endexo<br>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<br>* 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.<br>|

What is the study measuring?
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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 |