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

End Stage Renal Disease Clinical Trial

— bisphenol-A  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627118
• Other study ID #: 15-156-3
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: July 11, 2016

Study information

• Verified date: April 2018
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 11, 2016
• Est. primary completion date: July 11, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• FRESENIUS 160NR
2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR DIALYZER
• NIPRO ELISIO-15H
2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H DIALYZER

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
UConn Health	Dialysis Clinic, Inc., Nipro Medical Corporation

References & Publications (5)

Huang X, Huang J, Zhang L, Zhu Y, Li Y. A novel ERa-mediated reporter gene assay for screening estrogenic/antiestrogenic chemicals based on LLC-MK2 cells. Toxicol Mech Methods. 2014 Dec;24(9):627-32. doi: 10.3109/15376516.2014.945107. Epub 2014 Sep 26. — View Citation

Lang IA, Galloway TS, Scarlett A, Henley WE, Depledge M, Wallace RB, Melzer D. Association of urinary bisphenol A concentration with medical disorders and laboratory abnormalities in adults. JAMA. 2008 Sep 17;300(11):1303-10. doi: 10.1001/jama.300.11.1303. Epub 2008 Sep 16. — View Citation

Murakami K, Ohashi A, Hori H, Hibiya M, Shoji Y, Kunisaki M, Akita M, Yagi A, Sugiyama K, Shimozato S, Ito K, Takahashi H, Takahashi K, Yamamoto K, Kasugai M, Kawamura N, Nakai S, Hasegawa M, Tomita M, Nabeshima K, Hiki Y, Sugiyama S. Accumulation of bisphenol A in hemodialysis patients. Blood Purif. 2007;25(3):290-4. Epub 2007 Jul 2. — View Citation

Trasande L, Attina TM, Trachtman H. Bisphenol A exposure is associated with low-grade urinary albumin excretion in children of the United States. Kidney Int. 2013 Apr;83(4):741-8. doi: 10.1038/ki.2012.422. Epub 2013 Jan 9. — View Citation

Welshons WV, Nagel SC, vom Saal FS. Large effects from small exposures. III. Endocrine mechanisms mediating effects of bisphenol A at levels of human exposure. Endocrinology. 2006 Jun;147(6 Suppl):S56-69. Epub 2006 May 11. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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