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

NCT03536663 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-11-27

Study results available
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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."

Conditions

  • Kidney Failure, Chronic

Interventions

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.

Sponsors & Collaborators

  • Fresenius Medical Care North America

    lead INDUSTRY

Principal Investigators

  • Shakil Aslam, MD · Fresenius Medical Care RTG, LLC

  • Dylan Steer, MD · California Institute of Renal Research

  • Lisa Weber, MD · Research Management Inc/ Kansas Nephrology Research Institute, LLC-J/V

  • Jill Meyer, MD · Balboa Nephrology Med Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
22 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-29
Primary Completion
2019-04-17
Completion
2019-06-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03536663 on ClinicalTrials.gov