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

NCT06966635 | Recruiting Phase 4 DMC

• 1 other identifier: KY2024-641
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperuricemia or Gout; Nephrolithiasis

Outcome Measures

Primary Outcomes (1)

• serum uric acid

  From enrollment to the end of treatment at 48 weeks

Secondary Outcomes (1)

• gout flare

  From enrollment to the end of treatment at 48 weeks

Other Outcomes (1)

• nephrolithiasis

  From enrollment to the end of treatment at 48 weeks

Study Arms (3)

Controll group

ACTIVE COMPARATOR

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.

Drug: uric-acid-lowering drug

Potassium citrate group

EXPERIMENTAL

On the basis of the standard uric acid-lowering treatment plan, potassium citrate was taken three times a day, 2.16g each time.

Drug: Potassium Citrate Tablets; Drug: uric-acid-lowering drug

Sodium bicarbonate group

EXPERIMENTAL

Sodium Bicarbonate Oral Capsule

Drug: Sodium Bicarbonate Oral Capsule; Drug: uric-acid-lowering drug

Interventions

Sodium Bicarbonate Oral Capsule DRUG

On the basis of the standard uric acid-lowering treatment plan, sodium bicarbonate should be taken three times a day, 1.0g each time

Sodium bicarbonate group

Potassium Citrate Tablets DRUG

On the basis of the standard uric acid-lowering treatment plan, potassium citrate was taken three times a day, 2.16g each time

Potassium citrate group

uric-acid-lowering drug DRUG

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. The treatment plan for lowering uric acid remained unchanged for 4 weeks after enrollment in the clinical study until the endpoint.

Controll group; Potassium citrate group; Sodium bicarbonate group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan hospital, Fudan university

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Hyperuricemia; Gout; Nephrolithiasis

Interventions

Sodium Bicarbonate; Potassium Citrate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Yu Miao

CONTACT

021-17857540080; my20000109@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 13, 2025
• Study Start: April 10, 2024
• Primary Completion: December 31, 2025
• Study Completion: April 30, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months and ending 3 years after the publication of results

Locations

CN (1)