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

NCT05155267 | Recruiting DMC

• 1 other identifier: 1-1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Diseases; Microplastics; Nanoplastics; Genotoxic Damage

Keywords

CKD; MNPLs

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

Chronic Kidney disease participants (CKD)_HD

CKD submitted to hemodialysis (HD)

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

Chronic Kidney disease participants (CKD)_PD

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

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

Controls

Healthy participants

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

Interventions

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

Determination of MNPLs levels, genotoxic damage and immunological effects

Chronic Kidney disease participants (CKD)_HD; Chronic Kidney disease participants (CKD)_PD; Controls

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This project will study a minimum of 25 adult participants with chronic kidney disease, included and not included in an haemodialysis programme. A control group (at least 25 individuals), matched by gender, age and lifestyle with CKD participants will be also included.

You may qualify if:

• 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
• 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
• 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)

You may not qualify if:

• Clinical instability
• Life expectancy of less than 12 months
• Coagulation system disorders
• Participation in other clinical study
• Pregnancy
• Unsigned informed consent
• Participation in other clinical study
• Pregnancy
• Unsigned informed consent

Sponsors & Collaborators

• Ricard Marcos: lead
• Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca: collaborator
• Hospital Universitario Virgen de la Arrixaca: collaborator

Study Sites (1)

Servicio Murciano de Salud

Murcia, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine and feces

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 Officials

• Pablo Pelegrín

  Instituto Murciano de Investigación Biosanitaria (IMIB)

  PRINCIPAL INVESTIGATOR

• Juan Bernardo Cabezuelo

  Hospital Clínico Universitario Virgen Arrixaca (Murcia)

  STUDY CHAIR

• Laura Martínez

  Hospital Clínico Universitario Virgen Arrixaca (Murcia)

  STUDY CHAIR

Central Study Contacts

Ricard Marcos

CONTACT

+34 93 586 20 52; ricard.marcos@uab.cat

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 13, 2021
• Study Start: February 27, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

ES (1)