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Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexo™

NCT04511338 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-03-04

Study results available
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Summary

This study will assess the safety and efficacy of heparin free hemodialysis (HD) performed with dialyzers with Endexo in adult end-stage renal disease (ESRD) subjects on thrice-weekly in-center HD.

Conditions

  • Chronic Kidney Diseases
  • Patient Requiring Heparin Free Dialysis Treatments

Interventions

DEVICE

Dialyzer with Endexo

Sequence AB: Period 1 Circuit A (Five Visits: 1,2,3,4,5) Period 2 Circuit B (Five Visits: 9,10,11,12,13) Sequence BA: Period 1 Circuit B (Five Visits: 1,2,3,4,5) Period 2 Circuit A (Five Visits: 9,10,11,12,13)

Sponsors & Collaborators

  • Fresenius Medical Care North America

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-02
Primary Completion
2021-05-21
Completion
2021-06-16
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 NCT04511338 on ClinicalTrials.gov