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."
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
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.
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
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.
Time frame: 15 minutes after the recorded start of hemodialysis with Endexo upon its first use in the study
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.
Time frame: 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.
Time frame: 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
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.
Time frame: 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
Time frame: 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
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Time frame: Pre- and Post- HD at Visits 1/week 1, 13/week 5