NCT03536663

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Fresenius Medical Care North America · Industry
• Sex: All
• Age: 22 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Failure, Chronic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-08-29
• Primary completion: 2019-04-17
• Completion: 2019-06-17
• First posted: 2018-05-25
• Last updated: 2020-11-27
• Results posted: 2020-11-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study