FRESENIUS 160NR
Device2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR DIALYZER
NCT Number: NCT02627118
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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Notify Me18 year and older
Male
Interventional
Not applicable
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR DIALYZER
2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H DIALYZER
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
UConn Health
Other
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
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