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Role of Uralyt-U in Patients With Hyperuricemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04352153
Recruitment Status : Unknown
Verified April 2020 by Ai Peng, Shanghai 10th People's Hospital.
Recruitment status was:  Recruiting
First Posted : April 20, 2020
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Ai Peng, Shanghai 10th People's Hospital

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 1, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arms and Interventions
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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 Name: potassium sodium hydrogen citrate granules


Outcome Measures
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Primary Outcome Measures :
  1. Uric acid stones [ Time Frame: 3 months ]
    Uric acid stones will be estimated by dual-source CT examination

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


Secondary Outcome Measures :
  1. Blood uric acid [ Time Frame: 1 month ]
    Blood uric acid will be detected

  2. Blood uric acid [ Time Frame: 3 months ]
    Blood uric acid will be detected

  3. Blood uric acid [ Time Frame: 6 months ]
    Blood uric acid will be detected


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04352153


Contacts
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Contact: Ai Peng, Ph.D., M.D. 86-21-66302524 pengai@tongji.edu.cn
Contact: Jiafen Cheng, M.D. 86-21-66302527 chengjiafen@tongji.edu.cn

Locations
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China, Shanghai
Department of Nephrolgoy, Shanghai 10th People's Hospital Recruiting
Shanghai, Shanghai, China, 200072
Contact: Ai Peng, Ph.D., M.D.    86-21-66302524    pengai@hotmail.com   
Sponsors and Collaborators
Ai Peng
Investigators
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Principal Investigator: Ai Peng, Ph.D., M.D. Shanghai 10th People's Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ai Peng, Director of the department of Nephrology, Shanghai 10th people's hospital, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT04352153    
Other Study ID Numbers: Uralyt-U
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ai Peng, Shanghai 10th People's Hospital:
Uric Acid Stones
Hyperuricemia
Uralyt-U
Additional relevant MeSH terms:
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Nephrolithiasis
Hyperuricemia
Pathologic Processes
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urolithiasis
Male Urogenital Diseases
 Febuxostat
Citric Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Gout Suppressants
Antirheumatic Agents