Biomonitoring of Internal Exposure to MNPLs, and Its Effects, in Blood of Patients With Chronic Kidney Disease (CKD)

Chronic Kidney Diseases Clinical Trial

Official title:

Biomonitoring of Internal Exposure to MNPLs (Micro and NanoPlastics), and Its Effects, in Blood of Patients With Chronic Kidney Disease (CKD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05155267
• Other study ID #: 1-1
• Status: Recruiting
• Start date: February 27, 2024
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: Universitat Autonoma de Barcelona
• Contact: Ricard Marcos
• Phone: +34 93 586 20 52
• Email: ricard.marcos[@]uab.cat
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Micro and nanoplastics (MNPLs) effects on human heath is still preliminary. Chronic kidney disease (CKD) participants, specially does patients submitted to hemodialysis, are a population high exposed to plastics. The objective of our research is to be able to detect MNPLs on biological fluids of hemodialysis patients as well as their potential genotoxic and immunological damage.

Description:

The exponential increase in the production/use of plastic translates into a parallel increase of environmental plastic-waste that is continuously degraded into micro and nanoplastics (MNPLs). Information on the MNPLs' effects on human health is still preliminary and, furthermore, the limitations in current methodologies prevent accurate human exposure/risk assessment.

The study aims to analyse specific biomarkers of exposure to MNPLs in humans, as well as biomarkers of genetic damage, which will allow an association between exposure to these plastic materials and the optimisation of different techniques for the detection and characterisation of MNPLs.

The study will evaluate the effect of exposure to MNPLs, analysing the genotoxic damage, different biomarkers of exposure and the effects on microbiota, in different body samples (urine, blood and feces).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria for Chronic Kidney Disease (CKD) submitted to Hemodialysis:

• Participant submitted to hemodialysis for more than 3 months

• Between 18 and 85 years old

• Stable haemoglobin (more than 10 gr/dl)

• Absence of infectious disease at the date of sample collection and for a period of more than two weeks

• Absence of active neoplasia

• Stable vascular access

Inclusion Criteria for Chronic Kidney Disease (CKD) pre-dialysis:

• No hemodialysis treatment

• Between 18 and 85 years old

• Stable haemoglobin (more than 10 gr/dl)

• Glomerular filtration = 20 ml/min

• Absence of infectious disease at the date of sample collection and for a period of more than two weeks

• Absence of active neoplasia

Inclusion Criteria for controls :

• Between 18 and 85 years old (paired by gender, age and lifestyle to the CKD patients)

• Absence of chronic kidney disease or dialysis treatment

• Absence of chronic pathology (including neoplasia)

• Absence of infectious disease at the date of sample collection and for a period of more than two weeks

• Spanish residence

Exclusion Criteria for both groups of CKD patients:

• Clinical instability

• Life expectancy of less than 12 months

• Coagulation system disorders

• Participation in other clinical study

• Pregnancy

• Unsigned informed consent

Exclusion criteria for controls:

• Participation in other clinical study

• Pregnancy

• Unsigned informed consent

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Biomonitoring study to detect MNPLs in biological samples and study of their health effects
Determination of MNPLs levels, genotoxic damage and immunological effects

Locations

Country	Name	City	State
Spain	Servicio Murciano de Salud	Murcia

Sponsors (3)

Lead Sponsor	Collaborator
Ricard Marcos	Hospital Universitario Virgen de la Arrixaca, Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomonitoring study to detect the presence of MNPLs in biological fluids	Micro and nanoplastic and/or derivatives, would be evaluated. Characterization of possible biomarkers of early biological effects on human health	Up to 1 year
Primary	Study of the effects of MNPLs on immune system	Impact evaluation of MNPLs on transcriptome, secretome and inflammatory signalling and inflammasome activation. Investigating the effect of MNPLs on the function of the immune system in vivo and in high-risk individuals	Up to 1 year
Primary	Genotoxicity effects of exposure to MNPLs	Genotoxic, chromosome damage evaluation and oxidative DNA damage will be analysed by the Comet assay and the micronucleus assay	Up to 1 year