Kidney StoneNCT07350369
Research on Early Warning and Diagnosis & Treatment Pathway for Micro Kidney Stones
An observational study of Kidney Stone, run by Xijing Hospital at 1 site in China.
Trial summary
Exploring abnormal metabolism in kidney stone patients and developing drugs for kidney stone treatment and their mechanisms of action. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Detect the levels of metabolites in blood and urine
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 9 Mar 2026
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged between 18 and 70 years, with or without kidney stones.
Who may be able to join
- Inpatients treated in the Department of Urology at Xijing Hospital with a diagnosis of renal calculi confirmed by imaging examinations, including abdominal plain radiography, ultrasonography, or computed tomography (CT).
- Aged between 18 and 70 years, regardless of sex.
- Willing to participate in the study and providing informed consent for the use of residual blood and urine samples (remaining after routine clinical testing) for research purposes.
- Complete medical records available, including medical history, clinical symptoms, physical examination findings, previous treatments, and other relevant information.
- Control Group
- Inpatients treated in the Department of Urology at Xijing Hospital with no evidence of kidney stones or other urological diseases, as confirmed by urinary system ultrasonography, abdominal plain radiography, or urinary CT.
Show all 9Show fewer
- Aged between 18 and 70 years, with sex distribution matched to the case group.
- Willing to participate in the study and providing informed consent for the use of residual blood and urine samples (remaining after routine clinical testing) for research purposes.
- No history of kidney stones or other urological diseases.
Who cannot join
- Presence of severe systemic diseases that may affect kidney stone formation, including malignant tumors, heart failure, liver failure, or renal failure (serum creatinine > 354 μmol/L).
- Presence of other urological diseases, such as pyelonephritis, renal tuberculosis, renal cysts, or renal tumors.
- Presence of endocrine disorders, including hyperparathyroidism or hyperadrenocorticism.
- Pregnant or lactating women.
- Patients with psychiatric disorders, individuals unable to cooperate with the study, or those with a history of substance abuse or alcoholism.
- History of surgical intervention or extracorporeal shock wave lithotripsy (ESWL) for kidney stones within the past 3 months.
- Current use of medications that may influence kidney stone formation (e.g., diuretics, vitamin D, or calcium supplements) and inability to discontinue these medications.
- Insufficient blood or urine sample volume to meet analytical requirements, or samples that were severely contaminated or of poor quality and unsuitable for analysis.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation Army
Xi'an, Shaanxi, 710000
About this study
Exploring abnormal metabolism in kidney stone patients and developing drugs for kidney stone treatment and their mechanisms of action.
Read the detailed description
For eligible subjects who meet the inclusion and exclusion criteria, one tube (approximately 4 mL each) of blood and urine samples collected prior to surgery during hospitalization and already tested in clinical laboratories will be gathered. Serum will be separated from the blood samples, while the entire urine sample will be submitted without processing, for further targeted metabolomics analysis. By analyzing the results of targeted metabolomic profiling of amine-related substances, differences in amines and metabolites in blood and urine between kidney stone patients and healthy individuals will be assessed.
By measuring and comparing the levels of amine compounds in blood and their corresponding metabolites in urine, statistical analysis will be performed to identify specific amines that are elevated in blood and whose metabolites are simultaneously increased in urine. The underlying mechanisms of these elevations will be further investigated through experimental studies.
- Conditions
- Kidney Stone
- Being tested
- Detect the levels of metabolites in blood and urine
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detect the levels of metabolites in blood and urineOther
Detect the levels of metabolites in blood and urine
| Study group | Role | What they receive |
|---|---|---|
| Nephrolithiasis | For eligible subjects who meet the inclusion and exclusion criteria, one tube (approximately 4 mL each) of blood and urine samples collected prior to surgery during hospitalization and already tested will be gathered. Serum will be separated from the blood samples, while the entire urine sample will be submitted without processing. These samples will undergo further targeted metabolomics analysis. By measuring amine-related substances using targeted metabolomics, differences in amine compounds and metabolites in blood and urine between kidney stone patients and healthy individuals will be analyzed. Receives: Other: Detect the levels of metabolites in blood and urine | |
| Normal | For eligible subjects who meet the inclusion and exclusion criteria, one tube (approximately 4 mL each) of blood and urine samples collected prior to surgery during hospitalization and already tested will be gathered. Serum will be separated from the blood samples, while the entire urine sample will be submitted without processing. These samples will undergo further targeted metabolomics analysis. By measuring amine-related substances using targeted metabolomics, differences in amine compounds and metabolites in blood and urine between kidney stone patients and healthy individuals will be analyzed. Receives: Other: Detect the levels of metabolites in blood and urine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using liquid chromatography to measure the levels of 21 neurotransmitters and 5 biogenic amines in the blood, as well as 51 gut microbiota-derived metabolites in the urine, of patients with kidney stones and those without.
Blood and urine samples were collected from kidney stone patients and non-stone controls. Absolute concentrations of 21 neurotransmitters (e.g., dopamine, L-tyrosine, serotonin, 5-HIAA, tyramine) and 5 biogenic amines (spermidine, spermine, putrescine, ornithine, arginine) in blood, and 51 gut microbiota-derived metabolites (e.g., uric acid, shikimic acid, L-tryptophan, indoxyl-β-D-glucoside, 4-hydroxyphenylacetic acid, etc.) in urine were quantified using liquid chromatography.
All concentrations are reported in ng/g. Statistical analyses compared metabolite levels between groups and assessed their associations with kidney stone disease.
Measured: 25.08.01-25.11.01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Aug 2025
- Primary completion1 Jan 2026
- Study completion9 Mar 2026
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.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zhang ke ying zhang, doctor, Principal investigator, 中国人民解放军空军军医大学第一附属医院
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350369
- Sponsor's protocol ID
- KY20252397-F-1
- Status last verified
- Oct 2025
- First submitted
- 25 Dec 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Early Warning and Diagnosis & Treatment Pathway for Micro Kidney Stones
- ClinicalTrials.gov ID
- NCT07350369
- Acronym / sponsor ID
- KY20252397-F-1
- Conditions
- Kidney Stone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 9 Mar 2026 (actual)
- First posted
- 20 Jan 2026 (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.
Exploring abnormal metabolism in kidney stone patients and developing drugs for kidney stone treatment and their mechanisms of action.
Detailed description
For eligible subjects who meet the inclusion and exclusion criteria, one tube (approximately 4 mL each) of blood and urine samples collected prior to surgery during hospitalization and already tested in clinical laboratories will be gathered. Serum will be separated from the blood samples, while the entire urine sample will be submitted without processing, for further targeted metabolomics analysis. By analyzing the results of targeted metabolomic profiling of amine-related substances, differences in amines and metabolites in blood and urine between kidney stone patients and healthy individuals will be assessed.
By measuring and comparing the levels of amine compounds in blood and their corresponding metabolites in urine, statistical analysis will be performed to identify specific amines that are elevated in blood and whose metabolites are simultaneously increased in urine. The underlying mechanisms of these elevations will be further investigated through experimental studies.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nephrolithiasis | – | Other: Detect the levels of metabolites in blood and urineFor eligible subjects who meet the inclusion and exclusion criteria, one tube (approximately 4 mL each) of blood and urine samples collected prior to surgery during hospitalization and already tested will be gathered. Serum will be separated from the blood samples, while the entire urine sample will be submitted without processing. These samples will undergo further targeted metabolomics analysis. By measuring amine-related substances using targeted metabolomics, differences in amine compounds and metabolites in blood and urine between kidney stone patients and healthy individuals will be analyzed. |
| Normal | – | Other: Detect the levels of metabolites in blood and urineFor eligible subjects who meet the inclusion and exclusion criteria, one tube (approximately 4 mL each) of blood and urine samples collected prior to surgery during hospitalization and already tested will be gathered. Serum will be separated from the blood samples, while the entire urine sample will be submitted without processing. These samples will undergo further targeted metabolomics analysis. By measuring amine-related substances using targeted metabolomics, differences in amine compounds and metabolites in blood and urine between kidney stone patients and healthy individuals will be analyzed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged between 18 and 70 years, with or without kidney stones.
Key inclusion criteria (9 listed)
- Inpatients treated in the Department of Urology at Xijing Hospital with a diagnosis of renal calculi confirmed by imaging examinations, including abdominal plain radiography, ultrasonography, or computed tomography (CT).
- Aged between 18 and 70 years, regardless of sex.
- Willing to participate in the study and providing informed consent for the use of residual blood and urine samples (remaining after routine clinical testing) for research purposes.
- Complete medical records available, including medical history, clinical symptoms, physical examination findings, previous treatments, and other relevant information.
- Control Group
Key exclusion criteria (8 listed)
- Presence of severe systemic diseases that may affect kidney stone formation, including malignant tumors, heart failure, liver failure, or renal failure (serum creatinine > 354 μmol/L).
- Presence of other urological diseases, such as pyelonephritis, renal tuberculosis, renal cysts, or renal tumors.
- Presence of endocrine disorders, including hyperparathyroidism or hyperadrenocorticism.
- Pregnant or lactating women.
- Patients with psychiatric disorders, individuals unable to cooperate with the study, or those with a history of substance abuse or alcoholism.
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 |
|---|---|---|
| Detect the levels of metabolites in blood and urineDetect the levels of metabolites in blood and urine | Other | Nephrolithiasis, Normal |
Primary outcome
Using liquid chromatography to measure the levels of 21 neurotransmitters and 5 biogenic amines in the blood, as well as 51 gut microbiota-derived metabolites in the urine, of patients with kidney stones and those without.
Time frame: 25.08.01-25.11.01
Blood and urine samples were collected from kidney stone patients and non-stone controls. Absolute concentrations of 21 neurotransmitters (e.g., dopamine, L-tyrosine, serotonin, 5-HIAA, tyramine) and 5 biogenic amines (spermidine, spermine, putrescine, ornithine, arginine) in blood, and 51 gut microbiota-derived metabolites (e.g., uric acid, shikimic acid, L-tryptophan, indoxyl-β-D-glucoside, 4-hydroxyphenylacetic acid, etc.) in urine were quantified using liquid chromatography. All concentrations are reported in ng/g. Statistical analyses compared metabolite levels between groups and assessed their associations with kidney stone disease.
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 Mar 2026.
- 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.
zhang ke ying zhang, doctor principal investigator
中国人民解放军空军军医大学第一附属医院
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 Xijing Hospital at 1 site in China.
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 9 inclusion and 8 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 Mar 2026. 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 China. 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?
Using liquid chromatography to measure the levels of 21 neurotransmitters and 5 biogenic amines in the blood, as well as 51 gut microbiota-derived metabolites in the urine, of patients with kidney stones and those without. (time frame: 25.08.01-25.11.01). 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 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.