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.
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
- Recruiting
CHU Brugmann
Brussels, 1020
Agnieszka Pozdzik, MD,PhD, +32 (0)2 4752639, agnieszka.pozdzik@chu-brugmann.be
Agnieszka Pozdzik, MD,PhD
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:
- 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;
- 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.
Blood samplingOther
Blood sampling
Urine samplingOther
Urine sampling
| Study group | Role | What they receive |
|---|---|---|
| STONE group | Adult subjects with kidney stones disease Receives: Other: Blood sampling; Other: Urine sampling | |
| NON STONE group | Control 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.
Neutrophil extracellular traps (NETs) excretion in 24h urine collection
Assessment of NET excretion in 24h urine collection
Measured: 24 hours
Neutrophil extracellular traps (NETs) excretion in fasting urine
Assessment of NET excretion in fasting urine
Measured: 24 hours
Neutrophil extracellular traps (NETs) excretion in 2e morning urine
Assessment of NET excretion in 2e morning urine
Measured: 24 hours
Macrophages extracellular traps (MET's) excretion in 24h urine collection
Assessment of MET's in 24h urine collection
Measured: 24 hours
Macrophages extracellular traps (MET's) excretion in fasting urine
Assessment of MET's in fasting urine
Measured: 24 hours
Macrophages extracellular traps (MET's) excretion in 2e morning urine
Assessment of MET's in 2e morning urine
Measured: 24 hours
Secondary outcomes (2)
Neutrophil extracellular traps (NETs) plasma levels
Neutrophil extracellular traps (NETs) plasma levels
Measured: 24 hours
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.
- First posted14 May 2024
- Study start12 Sep 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Pozdzik, Brugmann University Hospital
- Investigators
- Agnieszka POZDZIK, Principal investigator, CHU Brugmann
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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06412822
- Acronym / sponsor ID
- STONET's
- Conditions
- Kidney Stone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 May 2024 (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.
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.
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:
- 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;
- to compare the NET/MET's concentrations in the urine with those in plasma
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STONE group | – | Other: Blood sampling, Other: Urine samplingAdult subjects with kidney stones disease |
| NON STONE group | – | Other: Blood sampling, Other: Urine samplingControl group: patients with acute and/or chronic kidney disease (CKD) without stones |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Patients with acute and/or chronic kidney disease, with stones or without stones, ambulatory or hospitalized in CHU Brugmann Brugmann.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Blood samplingBlood sampling | Other | NON STONE group, STONE group |
| Urine samplingUrine sampling | Other | NON STONE group, STONE group |
Primary outcome
Neutrophil extracellular traps (NETs) excretion in 24h urine collection
Time frame: 24 hours
Assessment of NET excretion in 24h urine collection
Neutrophil extracellular traps (NETs) excretion in fasting urine
Time frame: 24 hours
Assessment of NET excretion in fasting urine
Neutrophil extracellular traps (NETs) excretion in 2e morning urine
Time frame: 24 hours
Assessment of NET excretion in 2e morning urine
Macrophages extracellular traps (MET's) excretion in 24h urine collection
Time frame: 24 hours
Assessment of MET's in 24h urine collection
Macrophages extracellular traps (MET's) excretion in fasting urine
Time frame: 24 hours
Assessment of MET's in fasting urine
Macrophages extracellular traps (MET's) excretion in 2e morning urine
Time frame: 24 hours
Assessment of MET's in 2e morning urine
2 secondary outcomes
Neutrophil extracellular traps (NETs) plasma levels
Time frame: 24 hours
Macrophages extracellular traps (MET's) plasma levels
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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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.
Agnieszka POZDZIK principal investigator
CHU Brugmann
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 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.