Role of Uralyt-U in Patients With Hyperuricemia
Primary Purpose
Uric Acid Stones, Hyperuricemia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Febuxostat
Uralyt-U
Sponsored by
About this trial
This is an interventional treatment trial for Uric Acid Stones focused on measuring Uric Acid Stones, Hyperuricemia, Uralyt-U
Eligibility Criteria
Inclusion Criteria:
- 18-70 years old, male, outpatient or inpatient;
- Acidic urinary stones
- Serum uric acid value ≥480 µmol / L;
- Other concomitant diseases (such as hypertension, hyperlipidemia, diabetes, etc.) are in a stable condition, and the dosage of other diseases is not changed during the test.
- eGFR≥30ml / min;
Exclusion Criteria:
- Pregnant or lactating women;
- Patients with acute or chronic renal failure (eGFR <30ml / min);
- Patients with severe liver dysfunction (ALT, AST≥70 IU);
- In patients with uncontrolled hypertension, systolic blood pressure ≥160 and / or diastolic blood pressure ≥110mmHg;
- In uncontrolled diabetic patients, fasting blood glucose is> 10mmol / L, and / or glycated hemoglobin is ≥9%;
- Patients that are taking atorvastatin, losartan, amlodipine, fenofibrate, pyrazinamide, tincture diuretics, thiazide diuretics, glucocorticoids, immunosuppressive agents and other drugs that affect uric acid excretion Drugs, those taking aspirin at a dose of> 325mg / day;
- Cancer patients
Sites / Locations
- Department of Nephrolgoy, Shanghai 10th People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Single-use group
Research group
Arm Description
Febuxostat is taken at a dose of 20 mg once a day. During the medication period, the urine pH of each subject is monitored and recorded in the morning, noon and night.
Febuxostat is taken at a dose of 20 mg once a day, potassium sodium hydrogen citrate granules 7.5 g / day, 2.5 g / per time, three times a day. During the medication period, the urine pH of each subject is monitored and recorded in the morning, noon and night.
Outcomes
Primary Outcome Measures
Uric acid stones
Uric acid stones will be estimated by dual-source CT examination
Uric acid stones
Uric acid stones will be estimated by dual-source CT examination
Secondary Outcome Measures
Blood uric acid
Blood uric acid will be detected
Blood uric acid
Blood uric acid will be detected
Blood uric acid
Blood uric acid will be detected
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04352153
Brief Title
Role of Uralyt-U in Patients With Hyperuricemia
Official Title
A Randomized, Prospective, Controlled Study of the Efficacy and Safety of Uralyt-U Combined With Febuxostat in the Treatment of Hyperuricemia With Uric Acid Stones
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
October 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ai Peng
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to provide a more direct and objective basis for the widespread use of potassium sodium hydrogen citrate granules in the treatment of uric acid stones.
Detailed Description
Hyperuricemia (HUA) is a common systemic metabolic disease. Its incidence is increasing year by year and more young people suffer from hyperuricemia. HUA can not only cause the onset of gouty arthritis, and then affect joint function, and even cause joint deformities. It can also cause damage to multiple organs such as the heart, brain, and kidney through multiple channels. Chronic kidney disease (CKD) refers to chronic kidney structural and dysfunction caused by various reasons. HUA is an independent risk factor that accelerates the progress of CKD. Studies have shown that lowering uric acid is another key treatment to delay the progress of CKD. A large number of studies have shown that the formation of uric acid crystals is the main mechanism of inducing renal injury.
In 2017, the "Multidisciplinary Expert Consensus for the Diagnosis and Treatment of Hyperuricemia-Related Diseases in China" recommended that patients with hyperuricemia receiving uric acid lowering drugs, especially those treated with uric acid excretion drugs and patients with uric acid nephrolithiasis, recommended that the pH of urine be adjusted during pH6.2 ~ 6.9 to increase the solubility of uric acid in urine. It is recommended to use sodium bicarbonate or potassium sodium citrate drugs to alkalinize urine, but it is not clear if there is any difference in the kinetic parameters of urine alkalinity, compliance rate of alkalinized urine and safety between sodium bicarbonate and potassium sodium citrate. No "head-to-head" clinical publications have been reported. This clinical trial was designed to evaluate the rate of alkalinization of urine, the therapeutic effect of renal lithiasis and adverse reactions between the sodium bicarbonate and potassium sodium hydrogen citrate granules in healthy people and patients with hyperuricemia and renal calculi (uric acid). This study provides a more direct and objective basis for the widespread use of potassium sodium hydrogen citrate granules in the treatment of uric acid stones.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uric Acid Stones, Hyperuricemia
Keywords
Uric Acid Stones, Hyperuricemia, Uralyt-U
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single-use group
Arm Type
Experimental
Arm Description
Febuxostat is taken at a dose of 20 mg once a day. During the medication period, the urine pH of each subject is monitored and recorded in the morning, noon and night.
Arm Title
Research group
Arm Type
Experimental
Arm Description
Febuxostat is taken at a dose of 20 mg once a day, potassium sodium hydrogen citrate granules 7.5 g / day, 2.5 g / per time, three times a day. During the medication period, the urine pH of each subject is monitored and recorded in the morning, noon and night.
Intervention Type
Drug
Intervention Name(s)
Febuxostat
Other Intervention Name(s)
Uloric, Adenuric
Intervention Description
Febuxostat is taken at a dose of 20 mg once a day. During the medication period, the urine pH of each subject is monitored and recorded in the morning, noon and night.
Intervention Type
Drug
Intervention Name(s)
Uralyt-U
Other Intervention Name(s)
potassium sodium hydrogen citrate granules
Intervention Description
Febuxostat is taken at a dose of 20 mg once a day, potassium sodium hydrogen citrate granules 7.5 g / day, 2.5 g / per time, three times a day. During the medication period, the urine pH of each subject is monitored and recorded in the morning, noon and night.
Primary Outcome Measure Information:
Title
Uric acid stones
Description
Uric acid stones will be estimated by dual-source CT examination
Time Frame
3 months
Title
Uric acid stones
Description
Uric acid stones will be estimated by dual-source CT examination
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Blood uric acid
Description
Blood uric acid will be detected
Time Frame
1 month
Title
Blood uric acid
Description
Blood uric acid will be detected
Time Frame
3 months
Title
Blood uric acid
Description
Blood uric acid will be detected
Time Frame
6 months
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:
18-70 years old, male, outpatient or inpatient;
Acidic urinary stones
Serum uric acid value ≥480 µmol / L;
Other concomitant diseases (such as hypertension, hyperlipidemia, diabetes, etc.) are in a stable condition, and the dosage of other diseases is not changed during the test.
eGFR≥30ml / min;
Exclusion Criteria:
Pregnant or lactating women;
Patients with acute or chronic renal failure (eGFR <30ml / min);
Patients with severe liver dysfunction (ALT, AST≥70 IU);
In patients with uncontrolled hypertension, systolic blood pressure ≥160 and / or diastolic blood pressure ≥110mmHg;
In uncontrolled diabetic patients, fasting blood glucose is> 10mmol / L, and / or glycated hemoglobin is ≥9%;
Patients that are taking atorvastatin, losartan, amlodipine, fenofibrate, pyrazinamide, tincture diuretics, thiazide diuretics, glucocorticoids, immunosuppressive agents and other drugs that affect uric acid excretion Drugs, those taking aspirin at a dose of> 325mg / day;
Cancer patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ai Peng, Ph.D., M.D.
Phone
86-21-66302524
Email
pengai@tongji.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jiafen Cheng, M.D.
Phone
86-21-66302527
Email
chengjiafen@tongji.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ai Peng, Ph.D., M.D.
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nephrolgoy, Shanghai 10th People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ai Peng, Ph.D., M.D.
Phone
86-21-66302524
Email
pengai@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36261757
Citation
Xue W, Cheng J, Zhao J, Wang L, Peng A, Liu X. Comparison potassium sodium hydrogen citrate with sodium bicarbonate in urine alkalization: a prospective crossover-controlled trial. Int Urol Nephrol. 2023 Jan;55(1):61-68. doi: 10.1007/s11255-022-03387-y. Epub 2022 Oct 19.
Results Reference
derived
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Role of Uralyt-U in Patients With Hyperuricemia
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