CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
FRESENIUS 160NR +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02627118
NCT02627118N/ACompleted
CompareCT.gov

Clinical Study To Elucidate The Potential Effect of Dialyzer Leaching of BPA From the Fresenius Optiflux 160NR When Compared to a Non-BPA Containing Dialyzer, the Nipro ELISIO-15H

UConn Health·interventional·Posted Dec 10, 2015·Updated Jun 11, 2018

In Brief

A clinical study evaluating FRESENIUS 160NR and NIPRO ELISIO-15H for End Stage Renal Disease. Completed, enrolled 10 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Disease
Countries--
CollaboratorsNipro Medical Corporation, Dialysis Clinic, Inc.

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 10, 2015
Enrollment StartApr 1, 2015
Primary CompletionJul 11, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.6 years ago

Interventions

FRESENIUS 160NRdevice

2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR DIALYZER

NIPRO ELISIO-15Hdevice

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