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RecruitingNCT06966635Updated May 13, 2025

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

A Phase 4 interventional study of Sodium Bicarbonate Oral Capsule and Potassium Citrate Tablets in Hyperuricemia or Gout and Nephrolithiasis, sponsored by Huashan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-13.

Sponsored by Huashan Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
312
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

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.

02

Conditions studied

  • Hyperuricemia or Gout
  • Nephrolithiasis
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
312 participants (estimated)

Study arms

  • Active comparator
    Controll group

    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

  • Experimental
    Potassium citrate group

    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

  • Experimental
    Sodium bicarbonate group

    Sodium Bicarbonate Oral Capsule

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

Interventions

  • DrugSodium Bicarbonate Oral Capsule

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

  • DrugPotassium Citrate Tablets

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

  • Druguric-acid-lowering 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.

05

What researchers measure

Primary outcomes

  1. serum uric acid

    Time frame: From enrollment to the end of treatment at 48 weeks

Secondary outcomes

  1. gout flare

    Time frame: From enrollment to the end of treatment at 48 weeks

Other outcomes

  1. nephrolithiasis

    Time frame: From enrollment to the end of treatment at 48 weeks

06

Study locations

1 of 1 sites recruiting
  • Huashan hospital, Fudan university
    Shanghai, China
    • Yu Miao · Contact · my20000109@126.com · 021-17857540080
    • Xiaoxia Zhu · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — all IPD collected throughout the trial. Contact the author by email after the research is completed.

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06966635
Lead sponsor
Huashan Hospital
Responsible party
Zhu Xiaoxia (Associate Chief Physician, Huashan Hospital) — Principal investigator
First posted
May 13, 2025
Start date
Apr 10, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Apr 30, 2026 (estimated)
Last update
May 13, 2025

Study contacts

Yu Miao
Contact
my20000109@126.com
021-17857540080

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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