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A Clinical Study Comparing Basic Performance and Hemocompatibility of 3 Different Dialyzers in Hemodialysis Patients

NCT02433210 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-08-05

Study results available
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Summary

The aim of the study is to confirm the safety and clinical effectiveness of Nipro ELISIO-15H and to compare its performance characteristics and hemocompatibility with those of the commercially available dialyzers in U.S.A., Gambro Polyflux Revaclear and Fresenius F160NRe.

10 stable patients will be dialyzed 3 times/week with each dialyzer over 3 weeks. Blood samples for several parameters will be collected during hemodialysis to assess the performance and hemocompatibility of the dialyzers under study. Data thus collected will be analyzed for comparison by standard statistical analysis.

Conditions

  • End Stage Renal Disease (ESRD)

Interventions

DEVICE

ELISIO-15H

Each patient to undergo 3 successive hemodialysis/week with this dialyzer.

DEVICE

Revaclear

Each patient to undergo 3 successive hemodialysis/week with this dialyzer.

DEVICE

Optiflux

Each patient to undergo 3 successive hemodialysis/week with this dialyzer.

Sponsors & Collaborators

  • Nipro Medical Corporation

    collaborator INDUSTRY

  • Dialysis Clinic, Inc.

    collaborator INDUSTRY

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Madhukar Misra, MD · University of Missouri-Columbia

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-11-30
Completion
2018-08-31

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 NCT02433210 on ClinicalTrials.gov