- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04352153
Role of Uralyt-U in Patients With Hyperuricemia
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ai Peng, Ph.D., M.D.
- Phone Number: 86-21-66302524
- Email: pengai@tongji.edu.cn
Study Contact Backup
- Name: Jiafen Cheng, M.D.
- Phone Number: 86-21-66302527
- Email: chengjiafen@tongji.edu.cn
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200072
- Recruiting
- Department of Nephrolgoy, Shanghai 10th People's Hospital
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Contact:
- Ai Peng, Ph.D., M.D.
- Phone Number: 86-21-66302524
- Email: pengai@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single-use group
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.
During the medication period, the urine pH of each subject is monitored and recorded in the morning, noon and night.
Other Names:
|
Experimental: Research group
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.
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Uric acid stones
Time Frame: 3 months
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Uric acid stones will be estimated by dual-source CT examination
|
3 months
|
Uric acid stones
Time Frame: 6 months
|
Uric acid stones will be estimated by dual-source CT examination
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood uric acid
Time Frame: 1 month
|
Blood uric acid will be detected
|
1 month
|
Blood uric acid
Time Frame: 3 months
|
Blood uric acid will be detected
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3 months
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Blood uric acid
Time Frame: 6 months
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Blood uric acid will be detected
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ai Peng, Ph.D., M.D., Shanghai 10th People's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uralyt-U
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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