Exposure Of Bisphenol Analogues In Chronic Kidney Disease and Dialysis Patients

September 21, 2019 updated by: Ding Feng, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study on the Level of Bisphenol Compounds in Patients With Chronic Kidney Disease and Renal Replacement Therapy and Relationship Between Bisphenols and Dialyzer Membrane

In this retrospective study, the serum levels of Bisphenol A (BPA) and three BPA analogs, namely, bisphenol B (BPB), bisphenol S (BPS), and bisphenol F (BPF), in patients with CKD, patients on dialysis therapy and healthy control were investigated to find out if BPA and BPA analogs accumulates in patients with chronic kidney disease (CKD), and if hemodialysis filters contribute to bisphenol burden in patients on hemodialysis (HD).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

154

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Shanghai Ninth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with CKD, on dialysis in one center, and age- and gender- matched healthy volunteers were enrolled from Shanghai Ninth People's Hospital affiliated to Shanghai JiaoTong University.

Description

Inclusion Criteria:

  • age 18; informed consent

Exclusion Criteria:

  • absence of active inflammatory, infectious, malignant diseases, acute chronic kidney disease, or pregnancy at the initiation or during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Mild renal injury
CKD patients with eGFR ≥ 60 ml∙min-1∙ (1.73 m2)-1. The eGFR was evaluated by the Chronic Kidney Disease Epidemiology Collaboration (eGFR-EPI).
Moderate renal injury
CKD patients with eGFR between 30 ml∙min-1∙(1.73 m2)-1 to 60 ml∙min-1∙(1.73 m2)-1. The eGFR was evaluated by the Chronic Kidney Disease Epidemiology Collaboration (eGFR-EPI).
Severe renal injury
CKD patients with eGFR < 30 ml∙min-1∙(1.73 m2)-1. The eGFR was evaluated by the Chronic Kidney Disease Epidemiology Collaboration (eGFR-EPI).
Hemodialysis
uremic patients on hemodialysis therapy
Peritoneal dialysis
uremic patients on peritoneal dialysis
Healthy control
Healthy volunteers with no history of kidney diseases or any chronic diseases which may lead to renal injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: 2017.01-2018.06
2017.01-2018.06

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

December 30, 2017

Study Completion (ACTUAL)

June 30, 2018

Study Registration Dates

First Submitted

September 21, 2019

First Submitted That Met QC Criteria

September 21, 2019

First Posted (ACTUAL)

September 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2019

Last Update Submitted That Met QC Criteria

September 21, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPs

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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