Kidney StoneNCT04243772
Metabolic Risk Factors and Stones Composition in Adult Kidney Stone Formers
An observational study of Kidney Stone, run by Agnieszka Pozdzik at 1 site in Belgium.
Trial summary
Within the CHU Brugmann hospital, a multidisciplinary Renal Lithiasis and Mineral Metabolism clinic has been inaugurated in 2017. During the first months of 2018, the activities of the clinic have been focalized on the pre-analytical and analytical aspects of metabolic work-up. 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?
- Data extraction
- How many people
- 350 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Nov 2019to 12 Dec 2023
- 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 of the CHU Brugmann Hospital with active or past history of kidney stone (newly diagnosed or with relapse). Medical file data collection starts from 01 January 2018.
Who may be able to join
- Active or past history of kidney stone (newly diagnosed or with relapse)
- Age and sex matched controls from the hospital
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Within the CHU Brugmann hospital, a multidisciplinary Renal Lithiasis and Mineral Metabolism clinic has been inaugurated in 2017. During the first months of 2018, the activities of the clinic have been focalized on the pre-analytical and analytical aspects of metabolic work-up. 15 patients are followed on average per week. The clinic is recognized as one of the 24 core centers of the European Nephrolithiasis Network and it is the only clinic included in this network in Belgium. The actual practice of the clinic has been published in a survey regarding current practice patterns of stone centers across Europe. Following this publication, the members of the board of the European Nephrolithiasis Network have put as common effort to standardize the care of kidney stone formers and obtained endorsement to perform a second survey in each core center. The aim of this initiative is to share information from real patients in aggregate form. Each core center practice will be evaluated by the second survey by an analysis of the robustness of clinical, biological, urological and radiological data.
The main aim of this project consists in the constitution of a clinical, biological, urological and radiological database of followed patients. This database could be shared in aggregate form by using a specialized coding system for the patients. The database will enable the investigators to:
Read more
- describe the epidemiological and clinico-biological characteristics of the CHU Brugmann patient population
- gather information about the kidney function outcome
- analyze and classify identified prolithogenics factors
- characterize related metabolic disorders (diabetes mellitus, metabolic syndrome, arterial hypertension, chronic kidney diseases, osteoporosis...)
- identify the patients that could participate in the international trials on kidney stone disease
- identify the patients that will need a specialized genetic testing.
- evaluate the impact of the clinic activity and metabolic work-up on the rate of recurrence of kidney stones in the patient population.
The obtained data will be compared with the global data from the European Nephrolithiasis Network.
Read the detailed description
Nearly 10% of population suffer from kidney stone disease. Recent review reported that kidney stones represent an underestimated risk factor for further kidney function deterioration, arterial hypertension and cardiovascular diseases. They are furthermore a significant predictor of osteoporotic fractures.
This evidence needs to be very seriously considered in children and adolescent suffering from this disorder. The epidemiological registry data show an alarming, continous increase in the incidence of kidney stones in adults (both sexes) and intriguingly in children. During the last 25 years the incidence of nephrolithiasis in children has increased by approximately 6% to 10% annually and is now 50 per 100 000 adolescents. Stone incidence in children undergoing abdominal imaging more than doubled between 2011 and 2016. Moreover, the changes in stone compositions have been identified and remain relevant pathophysiological aspects in the epidemiology of kidney stones.
Acute nephritic colic access reflects only the end-point of mineral metabolism abnormalities - the kidney stone disease is considered as a chronic, systemic mineral metabolism disorder. The process of kidney stones formation - lithogenesis- is a consequence of imbalance between the promotors and inhibitors in the urine. The patients with kidney stone disease require a complete metabolic assessment.
The three main areas leading to stone formation are metabolism, diet and lifestyle. The main causes of kidney stones are most frequently related to an increase in salt and sugar intake, insufficient water intake and increased incidence of obesity. All this together leads to the supersaturation of several biochemical components excreted physiologically in the urine, resulting in fine in their crystallization, a first step in stone formation.
Metabolic work-up is recommended by the American Urology Association to identify and correct the factors responsible for urinary stone formation such as hypercalciuria, hyperoxaluria, hypocitraturia or abnormalities of urinary pH. The metabolic work-up includes the collection of urine during 24h. This is the most useful test, giving information about the patient's average chemical risk of stone formation and it is the nearest available body fluid to the actual formation and growth of the stone itself. Metabolism is dealt with through a concurrent blood and spot urine test. Diet is handled through a variable method of diary recorded by the patient on his free, home diet. Lifestyle is handled with through a standard questionnaire given by the physician.
Within the CHU Brugmann hospital, a multidisciplinary Renal Lithiasis and Mineral Metabolism clinic has been inaugurated in 2017. During the first months of 2018, the activities of the clinic have been focalized on the pre-analytical and analytical aspects of metabolic work-up. 15 patients are followed on average per week. The clinic is recognized as one of the 24 core centers of the European Nephrolithiasis Network and it is the only clinic included in this network in Belgium. The actual practice of the clinic has been published in a survey regarding current practice patterns of stone centers across Europe. Following this publication, the members of the board of the European Nephrolithiasis Network have put as common effort to standardize the care of kidney stone formers and obtained endorsement to perform a second survey in each core center. The aim of this initiative is to share information from real patients in aggregate form. Each core center practice will be evaluated by the second survey by an analysis of the robustness of clinical, biological, urological and radiological data.
The main aim of this project consists in the constitution of a clinical, biological, urological and radiological database of followed patients. This database could be shared in aggregate form by using a specialized coding system for the patients. The database will enable the investigators to:
- describe the epidemiological and clinico-biological characteristics of the CHU Brugmann patient population
- gather information about the kidney function outcome
- analyze and classify identified prolithogenics factors
- characterize related metabolic disorders (diabetes mellitus, metabolic syndrome, arterial hypertension, chronic kidney diseases, osteoporosis...)
- identify the patients that could participate in the international trials on kidney stone disease
- identify the patients that will need a specialized genetic testing.
- evaluate the impact of the clinic activity and metabolic work-up on the rate of recurrence of kidney stones in the patient population.
The obtained data will be compared with the global data from the European Nephrolithiasis Network.
- Conditions
- Kidney Stone
- Being tested
- Data extraction
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data extractionOther
Data extraction from medical files
| Study group | Role | What they receive |
|---|---|---|
| Lithiasic patients | Lithiasic patients of the CHU Brugmann Hospital Receives: Other: Data extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary tract stone composition
Urinary tract stone composition
Measured: 3 years
Metabolic screen results
Metabolic screen (fasting blood) results
Measured: 3 years
24 hour urine screen results
24 hour urine screen (first basal urine) results
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start12 Nov 2019
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agnieszka Pozdzik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Agnieszka Pozdzik, Brugmann University Hospital
- Investigators
- Mohamed El Mallouli, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243772
- Sponsor's protocol ID
- Metastone study
- Status last verified
- Apr 2024
- First submitted
- 24 Jan 2020
- Last updated
- 12 Apr 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 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Risk Factors and Stones Composition in Adult Kidney Stone Formers
- ClinicalTrials.gov ID
- NCT04243772
- Acronym / sponsor ID
- Metastone study
- Conditions
- Kidney Stone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Agnieszka PozdzikUniversity, hospital or other
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 28 Jan 2020 (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.
Within the CHU Brugmann hospital, a multidisciplinary Renal Lithiasis and Mineral Metabolism clinic has been inaugurated in 2017. During the first months of 2018, the activities of the clinic have been focalized on the pre-analytical and analytical aspects of metabolic work-up. 15 patients are followed on average per week. The clinic is recognized as one of the 24 core centers of the European Nephrolithiasis Network and it is the only clinic included in this network in Belgium. The actual practice of the clinic has been published in a survey regarding current practice patterns of stone centers across Europe. Following this publication, the members of the board of the European Nephrolithiasis Network have put as common effort to standardize the care of kidney stone formers and obtained endorsement to perform a second survey in each core center. The aim of this initiative is to share information from real patients in aggregate form. Each core center practice will be evaluated by the second survey by an analysis of the robustness of clinical, biological, urological and radiological data.
The main aim of this project consists in the constitution of a clinical, biological, urological and radiological database of followed patients. This database could be shared in aggregate form by using a specialized coding system for the patients. The database will enable the investigators to:
- describe the epidemiological and clinico-biological characteristics of the CHU Brugmann patient population
- gather information about the kidney function outcome
- analyze and classify identified prolithogenics factors
- characterize related metabolic disorders (diabetes mellitus, metabolic syndrome, arterial hypertension, chronic kidney diseases, osteoporosis...)
- identify the patients that could participate in the international trials on kidney stone disease
- identify the patients that will need a specialized genetic testing.
- evaluate the impact of the clinic activity and metabolic work-up on the rate of recurrence of kidney stones in the patient population.
The obtained data will be compared with the global data from the European Nephrolithiasis Network.
Detailed description
Nearly 10% of population suffer from kidney stone disease. Recent review reported that kidney stones represent an underestimated risk factor for further kidney function deterioration, arterial hypertension and cardiovascular diseases. They are furthermore a significant predictor of osteoporotic fractures.
This evidence needs to be very seriously considered in children and adolescent suffering from this disorder. The epidemiological registry data show an alarming, continous increase in the incidence of kidney stones in adults (both sexes) and intriguingly in children. During the last 25 years the incidence of nephrolithiasis in children has increased by approximately 6% to 10% annually and is now 50 per 100 000 adolescents. Stone incidence in children undergoing abdominal imaging more than doubled between 2011 and 2016. Moreover, the changes in stone compositions have been identified and remain relevant pathophysiological aspects in the epidemiology of kidney stones.
Acute nephritic colic access reflects only the end-point of mineral metabolism abnormalities - the kidney stone disease is considered as a chronic, systemic mineral metabolism disorder. The process of kidney stones formation - lithogenesis- is a consequence of imbalance between the promotors and inhibitors in the urine. The patients with kidney stone disease require a complete metabolic assessment.
The three main areas leading to stone formation are metabolism, diet and lifestyle. The main causes of kidney stones are most frequently related to an increase in salt and sugar intake, insufficient water intake and increased incidence of obesity. All this together leads to the supersaturation of several biochemical components excreted physiologically in the urine, resulting in fine in their crystallization, a first step in stone formation.
Metabolic work-up is recommended by the American Urology Association to identify and correct the factors responsible for urinary stone formation such as hypercalciuria, hyperoxaluria, hypocitraturia or abnormalities of urinary pH. The metabolic work-up includes the collection of urine during 24h. This is the most useful test, giving information about the patient's average chemical risk of stone formation and it is the nearest available body fluid to the actual formation and growth of the stone itself. Metabolism is dealt with through a concurrent blood and spot urine test. Diet is handled through a variable method of diary recorded by the patient on his free, home diet. Lifestyle is handled with through a standard questionnaire given by the physician.
Within the CHU Brugmann hospital, a multidisciplinary Renal Lithiasis and Mineral Metabolism clinic has been inaugurated in 2017. During the first months of 2018, the activities of the clinic have been focalized on the pre-analytical and analytical aspects of metabolic work-up. 15 patients are followed on average per week. The clinic is recognized as one of the 24 core centers of the European Nephrolithiasis Network and it is the only clinic included in this network in Belgium. The actual practice of the clinic has been published in a survey regarding current practice patterns of stone centers across Europe. Following this publication, the members of the board of the European Nephrolithiasis Network have put as common effort to standardize the care of kidney stone formers and obtained endorsement to perform a second survey in each core center. The aim of this initiative is to share information from real patients in aggregate form. Each core center practice will be evaluated by the second survey by an analysis of the robustness of clinical, biological, urological and radiological data.
The main aim of this project consists in the constitution of a clinical, biological, urological and radiological database of followed patients. This database could be shared in aggregate form by using a specialized coding system for the patients. The database will enable the investigators to:
- describe the epidemiological and clinico-biological characteristics of the CHU Brugmann patient population
- gather information about the kidney function outcome
- analyze and classify identified prolithogenics factors
- characterize related metabolic disorders (diabetes mellitus, metabolic syndrome, arterial hypertension, chronic kidney diseases, osteoporosis...)
- identify the patients that could participate in the international trials on kidney stone disease
- identify the patients that will need a specialized genetic testing.
- evaluate the impact of the clinic activity and metabolic work-up on the rate of recurrence of kidney stones in the patient population.
The obtained data will be compared with the global data from the European Nephrolithiasis Network.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lithiasic patients | – | Other: Data extractionLithiasic patients of the CHU Brugmann Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the CHU Brugmann Hospital with active or past history of kidney stone (newly diagnosed or with relapse). Medical file data collection starts from 01 January 2018.
Key inclusion criteria (2 listed)
- Active or past history of kidney stone (newly diagnosed or with relapse)
- Age and sex matched controls from the hospital
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Data extractionData extraction from medical files | Other | Lithiasic patients |
Primary outcome
Urinary tract stone composition
Time frame: 3 years
Urinary tract stone composition
Metabolic screen results
Time frame: 3 years
Metabolic screen (fasting blood) results
24 hour urine screen results
Time frame: 3 years
24 hour urine screen (first basal urine) results
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
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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.
Mohamed El Mallouli 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 Agnieszka Pozdzik 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 12 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary tract stone composition (time frame: 3 years). 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 12 Apr 2024.