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

Kidney Failure, Chronic Clinical Trial

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

Clinical Trial 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."

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03536663
Study type Interventional
Source Fresenius Medical Care North America
Contact
Status Completed
Phase N/A
Start date August 29, 2018
Completion date June 17, 2019
View Details
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