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Potential Effect of Dialyzer Leaching of BPA From the Fresenius Optiflux 160NR Compared to the Nipro ELISIO-15H

NCT02627118 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-06-11

Study results available
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Summary

The aim of the study is to identify hepatic enzyme and estrogen-dependent biochemical changes that occur when dialysis patients are treated with dialyzers known to leach BPA (Bisphenol-A) into the blood, such as the commercially available Fresenius F160NR, as compared with the same chemical evaluations in patients being treated with the non BPA containing Nipro Elisio-15H dialyzer. Evaluations of patient's chemistries will be obtained prior to and after 2 months of standard dialysis treatments with each dialyzer.

Conditions

Interventions

DEVICE

FRESENIUS 160NR

2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR DIALYZER

DEVICE

NIPRO ELISIO-15H

2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H DIALYZER

Sponsors & Collaborators

  • Nipro Medical Corporation

    collaborator INDUSTRY

  • Dialysis Clinic, Inc.

    collaborator INDUSTRY

  • UConn Health

    lead OTHER

Principal Investigators

  • Andre A Kaplan, MD · University of Connecticut

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-07-11
Completion
2016-07-11

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Entities

Diseases

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 NCT02627118 on ClinicalTrials.gov