Trial Outcomes & Findings for Potential Effect of Dialyzer Leaching of BPA From the Fresenius Optiflux 160NR Compared to the Nipro ELISIO-15H (NCT NCT02627118)

Results Overview

blood sampling of BPA (Bisphenol-A) in ng/mL following 2 months of dialysis with the Fresenius 160NR or the Nipro Elisio 15-H

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

2 MONTHS OF TREATMENT

Results posted on

2018-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Dialyzer Comparison 2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR followed by 2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dialyzer Comparison n=10 Participants 2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR followed by 2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H
Age, Continuous	56.1 years STANDARD_DEVIATION 16.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race/Ethnicity, Customized White Non-Hispanic/Latino	3 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	5 Participants n=5 Participants
Race/Ethnicity, Customized African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 MONTHS OF TREATMENT

Population: 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.

blood sampling of BPA (Bisphenol-A) in ng/mL following 2 months of dialysis with the Fresenius 160NR or the Nipro Elisio 15-H

Outcome measures

Outcome measures
Measure	Dialyzer Comparison n=9 Participants 2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR followed by 2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H
BPA Level Following 2 Months of Dialysis following Fresenius 160NR dialyzer	9.76 ng/mL Standard Error 14.65
BPA Level Following 2 Months of Dialysis following 2 months of Nipro Elisio 15-H dialyzer	1.55 ng/mL Standard Error 1.90

Adverse Events

FRESENIUS OPTIFLUX 160NR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NIPRO ELISIO-15H

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andre Kaplan, MD

UConn Health

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place