Exploratory Study on the Treatment of Gout With Potassium Citrate Sustained-release Tablets

Last updated: May 4, 2025
Sponsor: Huashan Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Collagen Vascular Diseases

Bone Diseases

Musculoskeletal Diseases

Treatment

uric-acid-lowering drug

Sodium Bicarbonate Oral Capsule

Potassium Citrate Tablets

Clinical Study ID

NCT06966635
KY2024-641
  • Ages 18-70
  • All Genders

Study Summary

To evaluate whether alkalization has the effect of lowering uric acid and reducing gout flare and determine whether alkalization has a role in the prevention and treatment of urinary calculi in gout, the research participants were divided into the control group, the potassium citrate group and the sodium bicarbonate group. 2 alkalization groups took potassium citrate three times a day 2.16g each time, or sodium bicarbonate three times a day, 1.0g each time, on the basis of the standard uric acid-lowering treatment plan. The control group was treated with the standard uric acid-lowering treatment regimen alone. Uric acid-lowering treatment plan: Maintain the individualized uric acid-lowering treatment plan at the time of patient enrollment. Traditional uric acid-lowering treatment plans include drugs that reduce uric acid production such as febuxostat and allopurinol, and drugs that increase uric acid excretion such as benzbromarone. At the time of enrollment, the uric acid-lowering drugs were stable.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meet the diagnostic criteria of the American College of Rheumatology (ACR) and theEuropean League against Rheumatism (EULAR) for gout in 2015

  • Age 18-70 years old, gender is not limited

  • The interval between the most recent acute onset of gout is at least > 2 weeks

  • Routine treatment with stable dose of uric-lowering drugs for > 4 weeks

  • For women who are likely to become pregnant, pregnancy tests must be negative, theymust not be lactating, they must be using an investigator-approved method ofcontraception, and they must agree to maintain this method of contraceptionthroughout the study

  • Study participants were informed, voluntarily signed informed consent, and agreed toparticipate in all visits, examinations, and treatments as required by the trialprotocol

  • Informed consent to the purpose and content of the research.

Exclusion

Exclusion Criteria:

  • Acute gout flare

  • Secondary gout caused by kidney disease, blood disease, or taking certain drugs,tumor radiotherapy and chemotherapy

  • Severe and unstable cardiovascular and cerebrovascular diseases (such as unstableangina pectoris, coronary angiogenesis, cerebral angiogenesis, transient ischemicattack, congestive heart failure, etc.), acute and difficult to control diseases,chronic diffuse connective tissue disease, xanthine urethral deposition, Lesch-Nyhansyndrome, untreated thyroid disease or kidney stones, treatment Patients with severehypertension (blood pressure > 160/100mmHg) or diabetes (fasting blood glucose > 11.1mmol/L) and organ transplantation that were not effectively controlled later

  • People who are allergic, have a history of allergy to test-related drugs (febuxositatablets, allopurinol tablets, benzbromarone, etoracoxib, colchicine, potassiumcitrate, etc.) or are allergic to test-related drug components

  • Active peptic ulcer or ulcer with bleeding and perforation, severe chronic diarrheaor recurrent skin disease in the past year

  • Blood white blood cell count < 3.0x109/L, hemoglobin < 90g/L, platelet count < 100x109/L, or other blood system diseases (such as severe anemia, idiopathicthrombocytopenic purpura, spleen enlargement, coagulation dysfunction, etc.)

  • Active stage of liver disease or abnormal liver function (ALT or AST≥2 times theupper limit of normal)

  • Patients with abnormal renal function (eGFR≤60ml/min/1.73m^2)

  • Patients with elevated blood potassium (5.5mmol/L) may have diseases or factors thatmay lead to hyperkalemia, such as type IV renal tubular acidosis and widespreadtissue injury

  • Urine PH value > 6.5 during screening

  • Combined use of the following drugs: Contains salicylate drugs such as aspirin (> 300mg/d), thiazide diuretics, potassium diuretics such as amphenopterine, Amiloride,ACEI, azathioprine, 6-mercaptopurine, theophylline, losartan, cyclosporin A,cyclophospfamide, pyrazinamide, glucocorticoid (except in acute episodes),Niergoline tablets, long-term use of insulin, Digitalis

  • Women who are pregnant, planning to become pregnant or breastfeeding mental illness,no self-knowledge, unable to accurately express or can not take drugs on time

  • A history of alcohol abuse or dependence on known drugs within the last two years

  • Those who have participated or are participating in other clinical trials withinthree months

  • The study participant is a family member or relative of the staff of the researchCenter

  • Other lesions or conditions that, in the investigator's judgment, reduce orcomplicate enrollment.

Study Design

Total Participants: 312
Treatment Group(s): 3
Primary Treatment: uric-acid-lowering drug
Phase: 4
Study Start date:
April 10, 2024
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • Huashan hospital, Fudan university

    Shanghai,
    China

    Active - Recruiting

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