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

Ricard Marcos

Status: Enrolling

Conditions: Chronic Kidney Diseases; Microplastics; Nanoplastics; Genotoxic Damage

Treatments: Other: Biomonitoring study to detect MNPLs in biological samples and study of their health effects

Study type: Observational

Funder types: Other

Identifiers

NCT05155267

1-1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

50 participants in 3 patient groups

Chronic Kidney disease participants (CKD)_HD

Description:

CKD submitted to hemodialysis (HD)

Treatment:

Other: Biomonitoring study to detect MNPLs in biological samples and study of their health effects

Chronic Kidney disease participants (CKD)_PD

Description:

CKD non-submitted to hemodialysis (pre-dialysis:PD)

Treatment:

Other: Biomonitoring study to detect MNPLs in biological samples and study of their health effects

Controls

Description:

Healthy participants

Treatment:

Other: Biomonitoring study to detect MNPLs in biological samples and study of their health effects