Role of Uralyt-U in Patients With Hyperuricemia

Hyperuricemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04352153
• Other study ID #: Uralyt-U
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: October 31, 2020

Study information

• Verified date: April 2020
• Source: Shanghai 10th People's Hospital
• Contact: Ai Peng, Ph.D., M.D.
• Phone: 86-21-66302524
• Email: pengai[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: October 31, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperuricemia
• Nephrolithiasis
• Uric Acid Stones

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Department of Nephrolgoy, Shanghai 10th People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ai Peng

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uric acid stones	Uric acid stones will be estimated by dual-source CT examination	3 months
Primary	Uric acid stones	Uric acid stones will be estimated by dual-source CT examination	6 months
Secondary	Blood uric acid	Blood uric acid will be detected	1 month
Secondary	Blood uric acid	Blood uric acid will be detected	3 months
Secondary	Blood uric acid	Blood uric acid will be detected	6 months