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

Launched by HUASHAN HOSPITAL · May 4, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring how potassium citrate, a medication that helps make urine less acidic, might lower uric acid levels and reduce gout flare-ups. Gout is a painful condition caused by high levels of uric acid in the body, which can lead to painful swelling in the joints. The study compares two groups receiving potassium citrate or sodium bicarbonate with a control group that is only getting standard treatment for gout. Researchers hope to find out if these treatments can also help prevent kidney stones in people with gout.

To participate in this study, you need to be between 18 and 70 years old and have been diagnosed with gout according to specific guidelines. You should not have had a gout flare for at least two weeks and must be on stable doses of uric acid-lowering medications for at least four weeks. Participants will take potassium citrate or sodium bicarbonate three times a day. It’s important to note that there are several health conditions and circumstances that could prevent someone from joining, such as severe heart issues or being pregnant. If you are interested in joining, you will need to provide informed consent and attend regular visits for check-ups and treatments throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Meet the diagnostic criteria of the American College of Rheumatology (ACR) and the European 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, they must not be lactating, they must be using an investigator-approved method of contraception, and they must agree to maintain this method of contraception throughout the study
• • Study participants were informed, voluntarily signed informed consent, and agreed to participate in all visits, examinations, and treatments as required by the trial protocol
• • Informed consent to the purpose and content of the research.
• 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 unstable angina pectoris, coronary angiogenesis, cerebral angiogenesis, transient ischemic attack, congestive heart failure, etc.), acute and difficult to control diseases, chronic diffuse connective tissue disease, xanthine urethral deposition, Lesch-Nyhan syndrome, untreated thyroid disease or kidney stones, treatment Patients with severe hypertension (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 (febuxosita tablets, allopurinol tablets, benzbromarone, etoracoxib, colchicine, potassium citrate, etc.) or are allergic to test-related drug components
• • Active peptic ulcer or ulcer with bleeding and perforation, severe chronic diarrhea or 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, idiopathic thrombocytopenic purpura, spleen enlargement, coagulation dysfunction, etc.)
• • Active stage of liver disease or abnormal liver function (ALT or AST≥2 times the upper 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 that may lead to hyperkalemia, such as type IV renal tubular acidosis and widespread tissue 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 within three months
• • The study participant is a family member or relative of the staff of the research Center
• • Other lesions or conditions that, in the investigator's judgment, reduce or complicate enrollment.