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

• Sponsor: UConn Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT02627118
• Collaborator: Nipro Medical Corporation (Other), Dialysis Clinic, Inc. (Industry)
• Enrollment: 10
• Arm: 1
• Duration (Months): 15.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease	Device: FRESENIUS 160NR; Device: NIPRO ELISIO-15H	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Jul 11, 2016
• Actual Study Completion Date: Jul 11, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dialyzer Comparison 2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR followed by 2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H	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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• UConn Health
• Nipro Medical Corporation
• Dialysis Clinic, Inc.

Investigators

• Principal Investigator: Andre A Kaplan, MD, University of Connecticut

Study Documents (Full-Text)

None provided.

More Information

Publications

• Huang X, Huang J, Zhang L, Zhu Y, Li Y. A novel ERα-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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Andre A. Kaplan, MEDICAL DIRECTOR UCONN DIALYSIS CENTER, UConn Health
• ClinicalTrials.gov Identifier: NCT02627118
• Other Study ID Numbers: 15-156-3
• First Posted: Dec 10, 2015
• Last Update Posted: Jun 11, 2018
• Last Verified: Apr 1, 2018

• Additional relevant MeSH terms: Kidney Failure, Chronic

Study Results

Participant Flow

Arm/Group Title	Dialyzer Comparison
Arm/Group Description	2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR followed by 2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Dialyzer Comparison
Arm/Group Description	2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR followed by 2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H
Overall Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.1 (16.6)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	10 100%
Race/Ethnicity, Customized (Count of Participants)
White Non-Hispanic/Latino	3 30%
Hispanic	5 50%
African American	1 10%
Other	1 10%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

When data was collected, BPA level was not measureable in one patient (lab reported the presence of unidentified "interfering substance") and that patient's data was removed from final analysis.

Arm/Group Title	Dialyzer Comparison
Arm/Group Description	2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR followed by 2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H
Measure Participants	9
following Fresenius 160NR dialyzer	9.76 (14.65)
following 2 months of Nipro Elisio 15-H dialyzer	1.55 (1.90)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dialyzer Comparison
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 1 sided
	Comments

Adverse Events

Arm/Group Title	FRESENIUS OPTIFLUX 160NR		NIPRO ELISIO-15H
Arm/Group Description	2 MONTHS OF DIALYSIS WITH THE FRESENIUS OPTIFLUX 160NR		2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H
All Cause Mortality
	FRESENIUS OPTIFLUX 160NR		NIPRO ELISIO-15H
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	FRESENIUS OPTIFLUX 160NR		NIPRO ELISIO-15H
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	FRESENIUS OPTIFLUX 160NR		NIPRO ELISIO-15H
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.