Hypouricemia, RenalPhase 4NCT04398251
A Randomized Clinical Trail of The Effect of Postoperative Uric Acid Control on Stone Recurrence and Renal Function in Patients With Hyperuricemia of Urolithiasis.
A Phase 4 study testing Febuxostat 40mg Tab in people with Hypouricemia, Renal and Urolithiasis, run by Xuhui Central Hospital, Shanghai at 1 site in China.
Trial summary
The purpose of this study was to explore the effects of uric acid control on stone recurrence and renal function in patients with calculi of hyperuricemia through a prospective controlled study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypouricemia, Renal, Urolithiasis
- What is being tested?
- Febuxostat 40mg Tab
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2020to 31 May 2022
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- .Over 18 years old, under 70 years old, regardless of sex .The subjects had no mental illness or language dysfunction, could understand the situation of this study and had signed an informed consent form.
- .No clinical manifestations of urinary tract infection, urinary routine examination showed urinary tract infection, but urinary etiology test was negative (urinary routine leukocytosis), treated with broad-spectrum antibiotics for more than 3 days.
- .Clinical manifestations of urinary tract infection, urine routine examination showed urinary tract infection, and patients with positive urinary etiology were treated with sensitive antibiotics for more than 7 days.
- Serum uric acid value ≥480 µmol / L
- urinary stones
Who cannot join
- Transplanted kidney
- Fever or urinary tract infection is not treated according to the inclusion criteria
- Pregnant women and female menstruation
- Unable to tolerate anesthesia or surgery due to severe systemic disease, heart disease, pulmonary insufficiency and important organ failure
- Patients with renal insufficiency Clcr <30 mL/min
- Those who take side effects of febuxostat，Patients with side effects of febuxostat, patients with a previous history of coronary heart disease
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200031
About this study
Official title: Department of Urology, Shanghai Xu-hui Central Hospital
The purpose of this study was to explore the effects of uric acid control on stone recurrence and renal function in patients with calculi of hyperuricemia through a prospective controlled study.
Read the detailed description
2020.1 -2020.12 patients with urolithiasis and hyperuricemia were enrolled in the urology department of our hospital (100 cases). The patients were informed of this study before operation and randomly divided into uric acid drug control group (n = 50) and non-drug control group (n = 50). The patients were followed up for 3 months, 6 months, 12 months and 18 months after operation.
Informations as age, sex, height, weight, calculation BMI, past medical history, history of gout, diabetes, hyperthyroidism, calcium supplements will be recorded.
Rapid blood glucose, serum total cholesterol, high density cholesterol, thyroid hormone detection, androgen, estrogen detection, serum sodium, potassium, chlorine, calcium, magnesium, phosphorus, serum uric acid will be tested.
Renogram test to evaluate the change of single renal function. The stones burden will be followed-up with ultrasound or kub or CT plain scan.
- Conditions
- Hypouricemia, Renal, Urolithiasis
- Being tested
- Febuxostat 40mg Tab, Non-drug control group
- Keywords
- Stone prevention, Renal function, Febuxostat
- Medical subject headings
- Renal hypouricemia, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Febuxostat 40mg TabDrug
For the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 40 mg three times a week.
Non-drug control groupBehavioural
All patients in the group are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly
| Study group | Role | What they receive |
|---|---|---|
| Uric acid drug control group | Experimental | For the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 40 mg three times a week Receives: Drug: Febuxostat 40mg Tab |
| Non-drug control group | Active comparator | They are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly. Receives: Behavioral: Non-drug control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone burdern stone burdern
Use ultrasound or kub or CT plain scan to follow up the patients.
Measured: Change from the base line of the stone's volume and quantity at 3 months.
Stone burdern stone burdern
Use ultrasound or kub or CT plain scan to follow up the patients.
Measured: Change from the base line of the stone's volume and quantity at 6 months.
Stone burdern stone burdern
Use ultrasound or kub or CT plain scan to follow up the patients.
Measured: Change from the base line of the stone's volume and quantity at 12 months.
Stone burdern stone burdern
Use ultrasound or kub or CT plain scan to follow up the patients.
Measured: Change from the base line of the stone's volume and quantity at 18 months.
Secondary outcomes (3)
Renal function
Total and partial renal function
Measured: Change from the base line of GFR at 6 months after the operation.
Renal function
Total and partial renal function
Measured: Change from the base line of GFR at 12 months after the operation.
Renal function
Total and partial renal function
Measured: Change from the base line of GFR at 18 months after the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start10 Apr 2020
- Primary completion31 Mar 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypouricemia, RenalStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2020.1 -2020.12 patients with urolithiasis and hyperuricemia were enrolled in the urology department of our hospital (100 cases). The patients were informed of this study before operation and randomly divided into uric acid drug control group (n = 50) and non-drug control group (n = 50). For non-drug control group: Patients are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly. Uric acid drug control group:or the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 20 mg three times a week
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuhui Central Hospital, Shanghai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Hong, Xuhui Central Hospital, Shanghai
- Investigators
- JianMing Guo, PHD,M.D, Study chair, Department of Urology, Zhongshan Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398251
- Sponsor's protocol ID
- 2020-043
- Status last verified
- May 2020
- First submitted
- 7 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Subject information, test results
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Urology, Shanghai Xu-hui Central Hospital
- ClinicalTrials.gov ID
- NCT04398251
- Acronym / sponsor ID
- 2020-043
- Conditions
- Hypouricemia, Renal, Urolithiasis
- Keywords
- Stone prevention, Renal function, Febuxostat
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xuhui Central Hospital, ShanghaiUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 21 May 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.
The purpose of this study was to explore the effects of uric acid control on stone recurrence and renal function in patients with calculi of hyperuricemia through a prospective controlled study.
Detailed description
2020.1 -2020.12 patients with urolithiasis and hyperuricemia were enrolled in the urology department of our hospital (100 cases). The patients were informed of this study before operation and randomly divided into uric acid drug control group (n = 50) and non-drug control group (n = 50). The patients were followed up for 3 months, 6 months, 12 months and 18 months after operation.
Informations as age, sex, height, weight, calculation BMI, past medical history, history of gout, diabetes, hyperthyroidism, calcium supplements will be recorded.
Rapid blood glucose, serum total cholesterol, high density cholesterol, thyroid hormone detection, androgen, estrogen detection, serum sodium, potassium, chlorine, calcium, magnesium, phosphorus, serum uric acid will be tested.
Renogram test to evaluate the change of single renal function. The stones burden will be followed-up with ultrasound or kub or CT plain scan.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2020.1 -2020.12 patients with urolithiasis and hyperuricemia were enrolled in the urology department of our hospital (100 cases). The patients were informed of this study before operation and randomly divided into uric acid drug control group (n = 50) and non-drug control group (n = 50). For non-drug control group: Patients are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly. Uric acid drug control group:or the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 20 mg three times a week
| Arm | Type | Receives |
|---|---|---|
| Uric acid drug control group | Experimental | Drug: Febuxostat 40mg TabFor the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 40 mg three times a week |
| Non-drug control group | Active comparator | Behavioral: Non-drug control groupThey are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- .Over 18 years old, under 70 years old, regardless of sex .The subjects had no mental illness or language dysfunction, could understand the situation of this study and had signed an informed consent form.
- .No clinical manifestations of urinary tract infection, urinary routine examination showed urinary tract infection, but urinary etiology test was negative (urinary routine leukocytosis), treated with broad-spectrum antibiotics for more than 3 days.
- .Clinical manifestations of urinary tract infection, urine routine examination showed urinary tract infection, and patients with positive urinary etiology were treated with sensitive antibiotics for more than 7 days.
- Serum uric acid value ≥480 µmol / L
- urinary stones
Key exclusion criteria (6 listed)
- Transplanted kidney
- Fever or urinary tract infection is not treated according to the inclusion criteria
- Pregnant women and female menstruation
- Unable to tolerate anesthesia or surgery due to severe systemic disease, heart disease, pulmonary insufficiency and important organ failure
- Patients with renal insufficiency Clcr <30 mL/min
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 |
|---|---|---|
| Febuxostat 40mg TabFor the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 40 mg three times a week. | Drug | Uric acid drug control group |
| Non-drug control groupAll patients in the group are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly | Behavioural | Non-drug control group |
Primary outcome
Stone burdern stone burdern
Time frame: Change from the base line of the stone's volume and quantity at 3 months.
Use ultrasound or kub or CT plain scan to follow up the patients.
Stone burdern stone burdern
Time frame: Change from the base line of the stone's volume and quantity at 6 months.
Use ultrasound or kub or CT plain scan to follow up the patients.
Stone burdern stone burdern
Time frame: Change from the base line of the stone's volume and quantity at 12 months.
Use ultrasound or kub or CT plain scan to follow up the patients.
Stone burdern stone burdern
Time frame: Change from the base line of the stone's volume and quantity at 18 months.
Use ultrasound or kub or CT plain scan to follow up the patients.
3 secondary outcomes
Renal function
Time frame: Change from the base line of GFR at 6 months after the operation.
Renal function
Time frame: Change from the base line of GFR at 12 months after the operation.
Renal function
Time frame: Change from the base line of GFR at 18 months after the operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: No. Subject information, test results
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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.
JianMing Guo, PHD,M.D study chair
Department of Urology, Zhongshan Hospital, Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Febuxostat 40mg Tab in people with Hypouricemia, Renal and Urolithiasis, run by Xuhui Central Hospital, Shanghai 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 5 inclusion and 6 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 21 May 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Stone burdern stone burdern (time frame: Change from the base line of the stone's volume and quantity at 3 months.). The study lists 4 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 21 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.