End Stage Renal Diseasebisphenol-ANCT02627118

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

A study testing FRESENIUS 160NR and NIPRO ELISIO-15H in people with End Stage Renal Disease, run by UConn Health.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: End Stage Renal Disease
What is being tested?: FRESENIUS 160NR and NIPRO ELISIO-15H
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: No sites listed yet
Study dates: Apr 2015to 11 Jul 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.)

About this study

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

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.

Read the 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).

Conditions: End Stage Renal Disease
Being tested: FRESENIUS 160NR, NIPRO ELISIO-15H
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FRESENIUS 160NRDevice
2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR DIALYZER
NIPRO ELISIO-15HDevice
2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H DIALYZER

Study groups in NCT02627118
Study group	Role	What they receive
Dialyzer Comparison	Experimental	2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR followed by 2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H Receives: Device: FRESENIUS 160NR; Device: NIPRO ELISIO-15H

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 2 MONTHS OF TREATMENT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201511 Jul 2016

First posted10 Dec 2015 (estimated)
Study startApr 2015
Primary completion11 Jul 2016
Study completion11 Jul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02627118
Sponsor's protocol ID: 15-156-3
Acronym: bisphenol-A
Status last verified: Apr 2018
First submitted: 8 Dec 2015
Last updated: 11 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 17622711
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.
PubMed 25045971
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.
PubMed 16690810
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.
PubMed 18799442
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.
PubMed 23302717

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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RecruitingObservational study
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RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
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All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02627118
Acronym / sponsor ID: bisphenol-A / 15-156-3
Conditions: End Stage Renal Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: UConn HealthUniversity, hospital or other
Collaborators: Nipro Medical Corporation, Dialysis Clinic, Inc.
Study start: Apr 2015
Primary completion: 11 Jul 2016 (actual)
Study completion: 11 Jul 2016 (actual)
First posted: 10 Dec 2015 (estimated)
Results: Posted 11 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dialyzer Comparison	Experimental	Device: FRESENIUS 160NR, Device: NIPRO ELISIO-15H2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR followed by 2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (4 listed)

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.)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FRESENIUS 160NR2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR DIALYZER	Device	Dialyzer Comparison
NIPRO ELISIO-15H2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H DIALYZER	Device	Dialyzer Comparison

Primary outcome

BPA Level Following 2 Months of Dialysis
Time frame: 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

Results and safety

Results posted to the registry on 11 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dialyzer Comparison	10	10

Primary outcome: BPA Level Following 2 Months of Dialysis

Time frame: 2 MONTHS OF TREATMENT. Mean (Standard Error). Unit: ng/mL

Measure	Dialyzer Comparison n = 9
following Fresenius 160NR dialyzer	9.76 (14.65)
following 2 months of Nipro Elisio 15-H dialyzer	1.55 (1.90)

Dialyzer Comparison: p = 0.05, t-test, 1 sided

Population analysed: 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.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FRESENIUS OPTIFLUX 160NR	0 of 10 (0%)	0 of 10 (0%)	0 of 10
NIPRO ELISIO-15H	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17622711Murakami 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.
Background: PubMed 25045971Huang 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.
Background: PubMed 16690810Welshons 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.
Background: PubMed 18799442Lang 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.
Background: PubMed 23302717Trasande 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.

Related trials for End Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andre A Kaplan, MD principal investigator

University of Connecticut

Questions about this trial

What is this clinical trial studying?

A study testing FRESENIUS 160NR and NIPRO ELISIO-15H in people with End Stage Renal Disease, run by UConn Health.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BPA Level Following 2 Months of Dialysis (time frame: 2 MONTHS OF TREATMENT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02627118, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2018.