Skip to content

Exploratory study of potassium citrate sustained-release tablets in the treatment of gout

Exploratory study of potassium citrate sustained-release tablets in the treatment of gout

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103288
Enrollment
Unknown
Registered
2025-05-27
Start date
2024-04-10
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gouty kidney stones

Interventions

Control group:Basic uric acid lowering therapy
Potassium citrate group:Basic uric acid lowering therapy (maintain the individual uric acid lowering regimen at enrollment) combined with potassium citrate sustained-release
Sodium bicarbonate group:Basic uric acid lowering therapy (maintain the individual uric acid lowering regimen at enrollment) combined with sodium bicarbonate tablets (1g 3 tim

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of the American College of Rheumatology (ACR) and the European League against Rheumatism (EULAR) for gout in 2015; 2. Age 18-70 years old, gender is not limited; 3. The interval between the most recent acute onset of gout is at least > 2 weeks; 4. Routine treatment with stable dose of uric-lowering drugs for > 4 weeks; 5. 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; 6. Study participants were informed, voluntarily signed informed consent, and agreed to participate in all visits, examinations, and treatments as required by the trial protocol; 7. Informed consent to the purpose and content of the research.

Exclusion criteria

Exclusion criteria: 1. Acute gout flare; 2. Secondary gout caused by kidney disease, blood disease, or taking certain drugs, tumor radiotherapy and chemotherapy; 3. 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; 4. 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; 5. Active peptic ulcer or ulcer with bleeding and perforation, severe chronic diarrhea or recurrent skin disease in the past year; 6. Blood white blood cell count =2 times the upper limit of normal); 8. Patients with abnormal renal function (eGFR 6.5 during screening; 11. 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; 12. Women who are pregnant, planning to become pregnant or breastfeeding; 13. mental illness, no self-knowledge, unable to accurately express or can not take drugs on time; 14. A history of alcohol abuse or dependence on known drugs within the last two years; 15. Those who have participated or are participating in other clinical trials within three months; 16. The study participant is a family member or relative of the staff of the research Center; 17. Other lesions or conditions that, in the investigator's judgment, reduce or complicate enrollment.

Design outcomes

Primary

MeasureTime frame
Blood uric acid level;

Secondary

MeasureTime frame
Frequency of gouty arthritis;Urinary stone size;eGFR or creatinine;

Countries

China

Contacts

Public ContactZhu Xiaoxia

Huashan Hospital, Fudan University

1724101168@qq.com+86 19921258315

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026