Gout
Conditions
Interventions
Dapagliflozin group:Dapagliflozin 10 mg once daily combined with febuxostat 20 mg once daily, orally administered for 24 weeks
Placebo group:Febuxostat 20 mg once daily orally for 24 weeks
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 75 years inclusive, regardless of sex; 2.Body mass index (BMI) between 18.0 and 30.0 kg/m^2 inclusive; 3.Diagnosis of gout fulfilling the 2015 ACR/EULAR gout classification criteria; 4.Fasting serum uric acid levels>=480 µmol/L at both screening and baseline visits; 5.History of at least one acute gout flare within the 6 months prior to enrollment; 6.No plans for conception during the trial period and for 90 days after the last dose of study medication, and use of medically approved contraceptive methods; 7.Provision of voluntary written informed consent by the patient.
Exclusion criteria
Exclusion criteria: 1.History of an acute gout flare or use of urate-lowering therapy within 4 weeks prior to enrollment; 2.Concurrent other arthropathies, such as rheumatoid arthritis, psoriatic arthritis, calcium pyrophosphate deposition disease (pseudogout), systemic lupus erythematosus, or septic arthritis; 3.Presence of severe comorbid systemic conditions, including hepatic or renal insufficiency, poorly controlled cardiovascular or cerebrovascular disease, or inadequately controlled hypertension or hypotension; 4.Diabetes mellitus or history of hypoglycemia; 5.Active or recurrent infection within the past 4 weeks, or chronic infections such as hepatitis B, tuberculosis, syphilis, or human immunodeficiency virus (HIV) infection; 6.Pregnant or lactating women; 7.History of malignancy (except for adequately treated non-melanoma skin cancer or in situ carcinoma with no evidence of recurrence for =5 years); 8.History of urolithiasis (urinary tract stones); 9.Known hypersensitivity or intolerance to dapagliflozin, febuxostat, or any of their excipients; 10.Daily use of glucocorticoids, colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs), or other uric acid–modifying agents within the past 3 months; 11.History of alcohol abuse or substance use disorder (including cannabis), or current evidence of drug dependence or misuse; 12.Known intolerance to the investigational product; 13.Participation in another interventional drug clinical trial within the screening period or concurrently.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants experiencing acute gout flares from baseline to week 24 of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of participants who experienced an acute gout flare between baseline and week 12 of treatment;The proportion of participants with serum uric acid levels <360 µmol/L at each study visit;The proportion of participants with serum uric acid levels <300 µmol/L at each study visit;The percentage change in serum uric acid levels from baseline at each study visit;Changes in the number of tophi and the degree of change in tophus diameter from baseline to week 24 of treatment; | — |
Countries
China
Contacts
Public ContactSun Xiaoying
Peking University First Hospital
Outcome results
None listed