Back to resultsA Randomized Clinical Trail of The Effect of Postoperative Uric Acid Control on Stone Recurrence and Renal Function in Patients With Hyperuricemia of Urolithiasis.
Primary Purpose
Hypouricemia, Renal, Urolithiasis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Febuxostat 40mg Tab
Non-drug control group
Sponsored by
About this trial
This is an interventional prevention trial for Hypouricemia, Renal focused on measuring Stone prevention, Renal function, Febuxostat
Eligibility Criteria
Inclusion Criteria:
- .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
Exclusion Criteria:
- 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
Sites / Locations
- Shanghai Xuhui Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Uric acid drug control group
Non-drug control group
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Stone burdern stone burdern
Use ultrasound or kub or CT plain scan to follow up the patients.
Stone burdern stone burdern
Use ultrasound or kub or CT plain scan to follow up the patients.
Stone burdern stone burdern
Use ultrasound or kub or CT plain scan to follow up the patients.
Stone burdern stone burdern
Use ultrasound or kub or CT plain scan to follow up the patients.
Secondary Outcome Measures
Renal function
Total and partial renal function
Renal function
Total and partial renal function
Renal function
Total and partial renal function
Full Information
NCT ID
NCT04398251
First Posted
May 7, 2020
Last Updated
May 19, 2020
Sponsor
Xuhui Central Hospital, Shanghai
1. Study Identification
Unique Protocol Identification Number
NCT04398251
Brief Title
A Randomized Clinical Trail of The Effect of Postoperative Uric Acid Control on Stone Recurrence and Renal Function in Patients With Hyperuricemia of Urolithiasis.
Official Title
Department of Urology, Shanghai Xu-hui Central Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xuhui Central Hospital, Shanghai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypouricemia, Renal, Urolithiasis
Keywords
Stone prevention, Renal function, Febuxostat
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Masking Description
Make a random table, and the patients are divided into the group according to the random table according to the order of enrollment.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Uric acid drug control group
Arm Type
Experimental
Arm Description
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
Arm Title
Non-drug control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Febuxostat 40mg Tab
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Non-drug control group
Intervention Description
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
Primary Outcome Measure Information:
Title
Stone burdern stone burdern
Description
Use ultrasound or kub or CT plain scan to follow up the patients.
Time Frame
Change from the base line of the stone's volume and quantity at 3 months.
Title
Stone burdern stone burdern
Description
Use ultrasound or kub or CT plain scan to follow up the patients.
Time Frame
Change from the base line of the stone's volume and quantity at 6 months.
Title
Stone burdern stone burdern
Description
Use ultrasound or kub or CT plain scan to follow up the patients.
Time Frame
Change from the base line of the stone's volume and quantity at 12 months.
Title
Stone burdern stone burdern
Description
Use ultrasound or kub or CT plain scan to follow up the patients.
Time Frame
Change from the base line of the stone's volume and quantity at 18 months.
Secondary Outcome Measure Information:
Title
Renal function
Description
Total and partial renal function
Time Frame
Change from the base line of GFR at 6 months after the operation.
Title
Renal function
Description
Total and partial renal function
Time Frame
Change from the base line of GFR at 12 months after the operation.
Title
Renal function
Description
Total and partial renal function
Time Frame
Change from the base line of GFR at 18 months after the operation.
Other Pre-specified Outcome Measures:
Title
Serum uric acid level
Description
Serum uric acid level
Time Frame
Chage from the base line at 3 months after the operation
Title
Serum uric acid level
Description
Serum uric acid level
Time Frame
Chage from the base line at 6 months after the operation
Title
Serum uric acid level
Description
Serum uric acid level
Time Frame
Chage from the base line at 12 months after the operation
Title
Serum uric acid level
Description
Serum uric acid level
Time Frame
Chage from the base line at 18 months after the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
.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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JianMing Guo, PHD,M.D
Organizational Affiliation
Department of Urology, Zhongshan Hospital, Shanghai
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Xuhui Central Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Subject information, test results
Learn more about this trial
A Randomized Clinical Trail of The Effect of Postoperative Uric Acid Control on Stone Recurrence and Renal Function in Patients With Hyperuricemia of Urolithiasis.
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