Role of Uralyt-U in Patients With Hyperuricemia

• ClinicalTrials.gov Identifier: NCT04352153
• Recruitment Status: Unknown
• First Posted: April 20, 2020
• Last Update Posted: April 20, 2020
• Sponsor: Ai Peng
• Information provided by (Responsible Party): Ai Peng, Shanghai 10th People's Hospital

Tracking Information

• First Submitted Date: April 10, 2020
• First Posted Date: April 20, 2020
• Last Update Posted Date: April 20, 2020
• Actual Study Start Date: April 1, 2020
• Estimated Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 16, 2020)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 16, 2020)

• Blood uric acid [ Time Frame: 1 month ]
  Blood uric acid will be detected
• Blood uric acid [ Time Frame: 3 months ]
  Blood uric acid will be detected
• Blood uric acid [ Time Frame: 6 months ]
  Blood uric acid will be detected

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Uric Acid Stones
• Hyperuricemia

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.
  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 Name: potassium sodium hydrogen citrate granules

Study Arms

• 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.
  Intervention: Drug: Febuxostat
• 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.
  Interventions:

  • Drug: Febuxostat
  • Drug: Uralyt-U

• 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. 2023 Jan;55(1):61-68. doi: 10.1007/s11255-022-03387-y. Epub 2022 Oct 19.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 16, 2020): 102
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 31, 2020
• Estimated Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04352153
• Other Study ID Numbers: Uralyt-U
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Ai Peng, Shanghai 10th People's Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Ai Peng
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Shanghai 10th People's Hospital
• Verification Date: April 2020