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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Device: FRESENIUS 160NR
* Device: NIPRO ELISIO-15H


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dialyzer Comparison<br>2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR followed by 2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H | Device: FRESENIUS 160NR<br>* 2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR DIALYZER<br>Device: NIPRO ELISIO-15H<br>* 2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H DIALYZER<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BPA Level Following 2 Months of Dialysis | blood sampling of BPA (Bisphenol-A) in ng/mL following 2 months of dialysis with the Fresenius 160NR or the Nipro Elisio 15-H | 2 MONTHS OF TREATMENT |