Hyperuricemia or GoutPhase 4NCT06966635
Exploratory Study on the Treatment of Gout With Potassium Citrate Sustained-release Tablets
A Phase 4 study testing Sodium Bicarbonate Oral Capsule, Potassium Citrate Tablets and uric-acid-lowering drug in people with Hyperuricemia or Gout and Nephrolithiasis, run by Huashan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperuricemia or Gout, Nephrolithiasis
- What is being tested?
- Sodium Bicarbonate Oral Capsule, Potassium Citrate Tablets and uric-acid-lowering drug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2024to 30 Apr 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan hospital, Fudan university
Shanghai
Yu Miao, 021-17857540080, my20000109@126.com
Xiaoxia Zhu
About this study
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
- Being tested
- Sodium Bicarbonate Oral Capsule, Potassium Citrate Tablets, uric-acid-lowering drug
- Medical subject headings
- Hyperuricemia, Gout, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Bicarbonate Oral CapsuleDrug
On the basis of the standard uric acid-lowering treatment plan, sodium bicarbonate should be taken three times a day, 1.0g each time
Potassium Citrate TabletsDrug
On the basis of the standard uric acid-lowering treatment plan, potassium citrate was taken three times a day, 2.16g each time
uric-acid-lowering drugDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Potassium Citrate Tablets; Drug: uric-acid-lowering drug |
| Sodium bicarbonate group | Experimental | Sodium Bicarbonate Oral Capsule Receives: Drug: Sodium Bicarbonate Oral Capsule; Drug: uric-acid-lowering drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum uric acid
Measured: From enrollment to the end of treatment at 48 weeks
Secondary outcomes (1)
gout flare
Measured: From enrollment to the end of treatment at 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start10 Apr 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperuricemia or GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Xiaoxia, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966635
- Sponsor's protocol ID
- KY2024-641
- Status last verified
- May 2025
- First submitted
- 4 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD collected throughout the trial. Contact the author by email after the research is completed.