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Completed

NCT Number: NCT02627118

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

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.

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Key information

About this study

The investigators propose to elucidate any eventual biochemical changes, and in particular, the in vivo estrogenic activity of BPA (Bisphenol-A), when BPA is being leached into the circulation by the Fresenius 160NR dialyzer as opposed to the same biochemical changes when there is no BPA being leached, as with the non-BPA containing Nipro Elisio-15H dialyzer. The estrogen dependent biochemical end points in humans include free testosterone, sex hormone binding globulin (SHBG) and thyroid binding globulin (TBG).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male ESRD patients 18 years or older
  • Stable on hemodialysis for more than 3 months
  • Stable hematocrit equal to or above 29 %
  • Stable vascular access
  • Stable anticoagulation
  • No active infection
  • Able to sign informed consent and able to participate in the study
  • Medically stable

Exclusion criteria

  • Participation in another study which may interfere with the planned study
  • Active infection
  • Medical conditions which may interfere with the study (unstable cardiac status, chronic liver disease, active hepatitis as defined by elevated liver enzymes)
  • Females (It is expected that potential changes in estrogenic activity that might be seen in patients exposed to BPA will be modest and would be masked by naturally occurring variability of estrogen activity in women at varying stages of gonadal activity (pre, post-menopausal, different points in menstrual cycle, eventual pregnancy, etc). Thus, limiting study to adult males will maximize the possibility of detecting any changes in estrogenic activity.)

Treatment and study plan

FRESENIUS 160NR

Device

2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR DIALYZER

NIPRO ELISIO-15H

Device

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

Primary outcomes

  1. BPA Level Following 2 Months of Dialysis

    Time frame: 2 MONTHS OF TREATMENT

    blood sampling of BPA (Bisphenol-A) in ng/mL following 2 months of dialysis with the Fresenius 160NR or the Nipro Elisio 15-H

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • Dialysis Clinic, Inc.
  • Nipro Medical Corporation

Registry information

Official study title

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

Acronym: bisphenol-A

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 10, 2015
Registry last updated
Jun 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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