Exposure Of Bisphenol Analogues In Chronic Kidney Disease and Dialysis Patients

NCT04100421 | Completed DMC

• 1 other identifier: BPs
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chronic Kidney Diseases; Hemodialysis Complication

Keywords

bisphenol; human exposure; chronic kidney disease; blood purification

Outcome Measures

Primary Outcomes (1)

• Death

  2017.01-2018.06

Study Arms (6)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• age 18; informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai Ninth People's Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kidney internal medicine professor

Study Record Dates

• First Submitted: September 21, 2019
• First Posted: September 24, 2019
• Study Start: June 1, 2017
• Primary Completion: December 30, 2017
• Study Completion: June 30, 2018
• Last Updated: September 24, 2019

Record last verified: 2019-09

Locations

CN (1)