End Stage Renal Disease
Conditions
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.
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).
Interventions
DEVICEFRESENIUS 160NR
2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR DIALYZER
DEVICENIPRO ELISIO-15H
2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H DIALYZER
Sponsors
Nipro Medical Corporation
Dialysis Clinic, Inc.
UConn Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dialyzer Comparison 2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR followed by 2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Dialyzer Comparison |
|---|---|
| Age, Continuous | 56.1 years STANDARD_DEVIATION 16.6 |
| Race/Ethnicity, Customized African American | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 5 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White Non-Hispanic/Latino | 3 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dialyzer Comparison | BPA Level Following 2 Months of Dialysis | following Fresenius 160NR dialyzer | 9.76 ng/mL | Standard Error 14.65 |
| Dialyzer Comparison | BPA Level Following 2 Months of Dialysis | following 2 months of Nipro Elisio 15-H dialyzer | 1.55 ng/mL | Standard Error 1.9 |
p-value: 0.05t-test, 1 sided