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Kidney StoneNCT06412822

Neutrophil Extracellular Traps (NET's) in Prevalent Kidney Stone

An observational study of Kidney Stone, run by Brugmann University Hospital at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Neutrophils are first responders to any kind of threat the body faces: infection, severe trauma, cancer, surgery... They produce the cytokines, induct oxidative stress and de-granulate toxic proteins to kill pathogens. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Stone
What is being tested?
Blood sampling and Urine sampling
How many people
500 participants
Where
1 siteBelgium
Study dates
12 Sep 2023to 31 Dec 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with acute and/or chronic kidney disease, with stones or without stones, ambulatory or hospitalized in CHU Brugmann Brugmann.

Who may be able to join

  • Patients with acute and/or chronic kidney disease, with stones or without stones, ambulatory or hospitalized in CHU Brugmann Brugmann.

Who cannot join

  • Malignancy or treatment for malignancy within 12 months prior to Screening with the exception of localized basal cell or squamous cell skin cancer. Note: Subjects whose malignancy is in remission and who are on a stable dose of chronic suppressive or maintenance therapy are not excluded.
  • Psychological illness or condition, interfering with the patient's compliance or ability to understand the requirements of the study.
  • Participation in another clinical trial.

Trial locations and contacts

1 site in 1 country.

Belgium1 site, 1 recruiting
  • CHU Brugmann

    Brussels, 1020

    Agnieszka Pozdzik, MD,PhD, +32 (0)2 4752639, agnieszka.pozdzik@chu-brugmann.be

    Agnieszka Pozdzik, MD,PhD

    Recruiting

Other trials in Belgium

About this study

Official title: Neutrophil Extracellular Traps (NET's) in Prevalent Kidney Stone, Cross-section, Non-drug Clinical Study-Analysis of Biological Fluids (Residual Human Body Material (RHBM)): STONET's Project

Neutrophils are first responders to any kind of threat the body faces: infection, severe trauma, cancer, surgery... They produce the cytokines, induct oxidative stress and de-granulate toxic proteins to kill pathogens. However the new mechanism related to the neutrophil extracellular traps release has been recognized as a new way of cell necrosis and has been called a NETosis.

NETosis is a hugely important new mechanism of human immune responses also described in various forms of acute kidney injury (ischemic, toxic, autoimmune). In certain kidney diseases, neutrophils release NETs and induce cell necrosis. Whether neutrophils die along with NET release, and if they do die, remains under study and is most likely context dependent. Extracellular traps (ETs) can be released also by macrophages. The ETs formation as well as macrophages extracellular traps (MET's) especially in kidney disease are cytotoxic and elicit inflammation, contributing to necro-inflammation of the early-injury phase of acute tubular necrosis in anti-neutrophil cytoplasmic antibody-related renal vasculitis, anti-glomerular basement membrane disease, lupus nephritis. Finally, acute kidney injury-related releases of dying renal cells or ETs promote organ injuries - for example, acute respiratory distress syndrome. According to the recent review the term 'NET formation' has been proposed as a better term to use instead of 'NETosis'. The formation of neutrophil extracellular traps (NETs) has been recently recognized as a unique modality of pathogen fixation (sticky extracellular chromatin) and pathogen killing (cytotoxic histones and proteases) during host immune responses, as well as collateral tissue damage.

Read more

Histones are potent mediators of injury in various cells. Indeed, extracellular histone induce microvascular endothelial cells and renal epithelial cells death in vitro, forms the pores that disrupt cell integrity and induce the cytolysis by their capacity of binding with membrane phospholipids and activation of inflammasome in the kidney leading to auto-entrainment of inflammation.

The activation of inflammation has been demonstrated in the experimental model of crystalline nephropathy related to the uncontrolled oxalate urinary excretion. Inhibition of inflammasome activation has been related with the preservation of kidney function. In patients with kidney stone disease the presence of crystals in the urine has been demonstrated to induce tubular epithelial cells injury that can theoretically trigger the NET's or MET's release and tissue inflammation.

NETs are now increasingly described as new targets for therapies, however largely under-estimated.

The role of release of ETs from neutrophils and macrophages during the kidney stone disease has never been studied in urine but the neutrophil extracellular trap (NET) formation-NETosis - was found significantly increased in the papillae of patients with brushite stones compared with CaOx stones.

The key objectives of this study are:

  1. to assess NET/MET's excretion in the urine as a non-invasive method of NET/MET'osis measurement in patients with kidney diseases as a new biomarker of early stage of cells damages reflecting kidney injury occurring in patients with uncontrolled stones and other renal diseases;
  2. to compare the NET/MET's concentrations in the urine with those in plasma
Conditions
Kidney Stone
Being tested
Blood sampling, Urine sampling
Medical subject headings
Kidney Calculi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06412822
Study groupRoleWhat they receive
STONE groupAdult subjects with kidney stones disease
Receives: Other: Blood sampling; Other: Urine sampling
NON STONE groupControl group: patients with acute and/or chronic kidney disease (CKD) without stones
Receives: Other: Blood sampling; Other: Urine sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neutrophil extracellular traps (NETs) excretion in 24h urine collection

    Assessment of NET excretion in 24h urine collection

    Measured: 24 hours

  2. Neutrophil extracellular traps (NETs) excretion in fasting urine

    Assessment of NET excretion in fasting urine

    Measured: 24 hours

  3. Neutrophil extracellular traps (NETs) excretion in 2e morning urine

    Assessment of NET excretion in 2e morning urine

    Measured: 24 hours

  4. Macrophages extracellular traps (MET's) excretion in 24h urine collection

    Assessment of MET's in 24h urine collection

    Measured: 24 hours

  5. Macrophages extracellular traps (MET's) excretion in fasting urine

    Assessment of MET's in fasting urine

    Measured: 24 hours

  6. Macrophages extracellular traps (MET's) excretion in 2e morning urine

    Assessment of MET's in 2e morning urine

    Measured: 24 hours

Secondary outcomes (2)
  1. Neutrophil extracellular traps (NETs) plasma levels

    Neutrophil extracellular traps (NETs) plasma levels

    Measured: 24 hours

  2. Macrophages extracellular traps (MET's) plasma levels

    Macrophages extracellular traps (MET's) plasma levels

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2024
  2. Study start12 Sep 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06412822
Sponsor's protocol ID
STONET's
Status last verified
May 2024
First submitted
7 May 2024
Last updated
14 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Stone, run by Brugmann University Hospital at 1 site in Belgium.

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 1 inclusion and 3 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 14 May 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 Belgium. 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 Agnieszka POZDZIK (3224752639, Agnieszka.POZDZIK@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neutrophil extracellular traps (NETs) excretion in 24h urine collection (time frame: 24 hours). The study lists 6 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 14 May 2024.

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