Chronic Kidney DiseasesNCT05155267
Biomonitoring of Internal Exposure to MNPLs, and Its Effects, in Blood of Patients With Chronic Kidney Disease (CKD)
An observational study of Chronic Kidney Diseases and Microplastics, run by Ricard Marcos at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Microplastics, Nanoplastics
- What is being tested?
- Biomonitoring study to detect MNPLs in biological samples and study of their health effects
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 27 Feb 2024to Jan 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Clinical instability
- Life expectancy of less than 12 months
- Coagulation system disorders
- Participation in other clinical study
- Pregnancy
- Unsigned informed consent
Show all 9Show fewer
- Participation in other clinical study
- Pregnancy
- Unsigned informed consent
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Servicio Murciano de Salud
Murcia
Laura Martinez, Dr., lma5@um.es
About this study
Official title: Biomonitoring of Internal Exposure to MNPLs (Micro and NanoPlastics), and Its Effects, in Blood of Patients With Chronic Kidney Disease (CKD)
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.
Read the detailed 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).
- Conditions
- Chronic Kidney Diseases, Microplastics, Nanoplastics, Genotoxic Damage
- Being tested
- Biomonitoring study to detect MNPLs in biological samples and study of their health effects
- Keywords
- CKD, MNPLs
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomonitoring study to detect MNPLs in biological samples and study of their health effectsOther
Determination of MNPLs levels, genotoxic damage and immunological effects
| Study group | Role | What they receive |
|---|---|---|
| Chronic Kidney disease participants (CKD)_HD | CKD submitted to hemodialysis (HD) Receives: 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) Receives: Other: Biomonitoring study to detect MNPLs in biological samples and study of their health effects | |
| Controls | Healthy participants Receives: Other: Biomonitoring study to detect MNPLs in biological samples and study of their health effects |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start27 Feb 2024
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ricard Marcos
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca, Hospital Universitario Virgen de la Arrixaca
- Responsible party
- Sponsor-investigator, Ricard Marcos, Universitat Autonoma de Barcelona
- Investigators
- Pablo Pelegrín, Principal investigator, Instituto Murciano de Investigación Biosanitaria (IMIB)Juan Bernardo Cabezuelo, Study chair, Hospital Clínico Universitario Virgen Arrixaca (Murcia)Laura Martínez, Study chair, Hospital Clínico Universitario Virgen Arrixaca (Murcia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155267
- Sponsor's protocol ID
- 1-1
- Status last verified
- Mar 2024
- First submitted
- 30 Nov 2021
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomonitoring of Internal Exposure to MNPLs (Micro and NanoPlastics), and Its Effects, in Blood of Patients With Chronic Kidney Disease (CKD)
- ClinicalTrials.gov ID
- NCT05155267
- Acronym / sponsor ID
- 1-1
- Conditions
- Chronic Kidney Diseases, Microplastics, Nanoplastics, Genotoxic Damage
- Keywords
- CKD, MNPLs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ricard MarcosUniversity, hospital or other
- Collaborators
- Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca, Hospital Universitario Virgen de la Arrixaca
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney disease participants (CKD)_HD | – | Other: Biomonitoring study to detect MNPLs in biological samples and study of their health effectsCKD submitted to hemodialysis (HD) |
| Chronic Kidney disease participants (CKD)_PD | – | Other: Biomonitoring study to detect MNPLs in biological samples and study of their health effectsCKD non-submitted to hemodialysis (pre-dialysis:PD) |
| Controls | – | Other: Biomonitoring study to detect MNPLs in biological samples and study of their health effectsHealthy participants |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Clinical instability
- Life expectancy of less than 12 months
- Coagulation system disorders
- Participation in other clinical study
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomonitoring study to detect MNPLs in biological samples and study of their health effectsDetermination of MNPLs levels, genotoxic damage and immunological effects | Other | Chronic Kidney disease participants (CKD)_HD, Chronic Kidney disease participants (CKD)_PD, Controls |
Primary outcome
Biomonitoring study to detect the presence of MNPLs in biological fluids
Time frame: Up to 1 year
Micro and nanoplastic and/or derivatives, would be evaluated. Characterization of possible biomarkers of early biological effects on human health
Study of the effects of MNPLs on immune system
Time frame: Up to 1 year
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
Genotoxicity effects of exposure to MNPLs
Time frame: Up to 1 year
Genotoxic, chromosome damage evaluation and oxidative DNA damage will be analysed by the Comet assay and the micronucleus assay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Pelegrín principal investigator
Instituto Murciano de Investigación Biosanitaria (IMIB)
Juan Bernardo Cabezuelo study chair
Hospital Clínico Universitario Virgen Arrixaca (Murcia)
Laura Martínez study chair
Hospital Clínico Universitario Virgen Arrixaca (Murcia)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Microplastics, run by Ricard Marcos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricard Marcos (+34 93 586 20 52, ricard.marcos@uab.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomonitoring study to detect the presence of MNPLs in biological fluids (time frame: Up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.