N/A N=10 Diagnostic

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

End Stage Renal Disease

Bottom Line

View on ClinicalTrials.gov: NCT02627118 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2018

Primary outcome: Primary: BPA Level Following 2 Months of Dialysis — 9.76; 1.55 ng/mL — p=0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: FRESENIUS 160NR (Device); NIPRO ELISIO-15H (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: UConn Health
Primary completion: Jul 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY BPA Level Following 2 Months of Dialysis	9.76; 1.55	0.05

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.

Eligibility Criteria

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.)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02627118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.