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

Not Applicable

Completed

• Conditions: End Stage Renal Disease
• Interventions: Device: FRESENIUS 160NR; Device: NIPRO ELISIO-15H

• Registration Number: NCT02627118
• Lead Sponsor: UConn Health

Brief 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).

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-12-08
• Study First Submitted QC: 2015-12-08
• Study First Posted: 2015-12-10
• Primary Completion: 2016-07-11
• Study Completion: 2016-07-11
• Status Verified: 2018-04
• Results First Submitted: 2018-04-04
• Results First Submitted QC: 2018-05-11
• Last Update Submitted: 2018-05-11
• Results First Posted: 2018-06-11
• Last Update Posted: 2018-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dialyzer Comparison	NIPRO ELISIO-15H	2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR followed by 2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H
Dialyzer Comparison	FRESENIUS 160NR	2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR followed by 2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H

Primary Outcome Measures

Name	Time	Method
BPA Level Following 2 Months of Dialysis	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