NCT02627118

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: UConn Health · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-07-11
• Completion: 2016-07-11
• First posted: 2015-12-10
• Last updated: 2018-06-11
• Results posted: 2018-06-11