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

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.

Study Overview

• Status: Unknown
• Conditions: Hyperuricemia; Uric Acid Stones
• Intervention / Treatment: Drug: Febuxostat; Drug: Uralyt-U

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: Interventional
• Enrollment (Anticipated): 102
• 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

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Recruiting
      • Department of Nephrolgoy, Shanghai 10th People's Hospital
      • Contact: Ai Peng, Ph.D., M.D.; Phone Number: 86-21-66302524; Email: pengai@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

2

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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uric acid stones	Uric acid stones will be estimated by dual-source CT examination	3 months
Uric acid stones	Uric acid stones will be estimated by dual-source CT examination	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood uric acid	Blood uric acid will be detected	1 month
Blood uric acid	Blood uric acid will be detected	3 months
Blood uric acid	Blood uric acid will be detected	6 months

Collaborators and Investigators

• Sponsor: Ai Peng
• Investigators: Principal Investigator: Ai Peng, Ph.D., M.D., Shanghai 10th People's Hospital

Publications and helpful links

General Publications

• 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. 2022 Oct 19. doi: 10.1007/s11255-022-03387-y. [Epub ahead of print]

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): October 31, 2020

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Hyperuricemia; Uric Acid Stones; Uralyt-U
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Urolithiasis; Nephrolithiasis; Hyperuricemia; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Anticoagulants; Chelating Agents; Sequestering Agents; Gout Suppressants; Calcium Chelating Agents; Citric Acid; Febuxostat
• Other Study ID Numbers: Uralyt-U

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No