Role of Uralyt-U in Patients With Hyperuricemia

Sponsor

Ai Peng (Other)

Overall Status

Unknown status

CT.gov ID

NCT04352153

Collaborator

(none)

102

Enrollment

Location

Arms

Anticipated Duration (Months)

14.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uric Acid Stones Hyperuricemia	Drug: Febuxostat Drug: Uralyt-U	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Sep 30, 2020

Anticipated Study Completion Date :

Oct 31, 2020

Arms and Interventions

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.	Drug: Febuxostat 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: Uloric Adenuric
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.	Drug: Febuxostat 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: Uloric Adenuric Drug: Uralyt-U 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: potassium sodium hydrogen citrate granules

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.

Drug: Febuxostat

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:

Uloric

Adenuric

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.

Drug: Febuxostat

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:

Uloric

Adenuric

Drug: Uralyt-U

Other Names:

potassium sodium hydrogen citrate granules

Outcome Measures

Primary Outcome Measures

Uric acid stones [3 months]
Uric acid stones will be estimated by dual-source CT examination
Uric acid stones [6 months]
Uric acid stones will be estimated by dual-source CT examination

Secondary Outcome Measures

Blood uric acid [1 month]
Blood uric acid will be detected
Blood uric acid [3 months]
Blood uric acid will be detected
Blood uric acid [6 months]
Blood uric acid will be detected

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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