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

NCT02627118 | Completed Results

• 1 other identifier: 15-156-3
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Dialyzer Comparison

EXPERIMENTAL

2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR followed by 2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H

Device: FRESENIUS 160NR; Device: NIPRO ELISIO-15H

Interventions

FRESENIUS 160NR DEVICE

2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR DIALYZER

Dialyzer Comparison

NIPRO ELISIO-15H DEVICE

2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H DIALYZER

Dialyzer Comparison

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• UConn Health: lead
• Nipro Medical Corporation: collaborator
• Dialysis Clinic, Inc.: collaborator

Related Publications (5)

• 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. doi: 10.1159/000104869. Epub 2007 Jul 2.

  PMID: 17622711 BACKGROUND

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

  PMID: 25045971 BACKGROUND

• 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. doi: 10.1210/en.2005-1159. Epub 2006 May 11.

  PMID: 16690810 BACKGROUND

• 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.

  PMID: 18799442 BACKGROUND

• 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.

  PMID: 23302717 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Andre Kaplan, MD
• Organization: UConn Health

kaplan@uchc.edu

Study Officials

• Andre A Kaplan, MD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MEDICAL DIRECTOR UCONN DIALYSIS CENTER

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 10, 2015
• Study Start: April 1, 2015
• Primary Completion: July 11, 2016
• Study Completion: July 11, 2016
• Last Updated: June 11, 2018
• Results First Posted: June 11, 2018

Record last verified: 2018-04