Hyperuricemia, gout
Conditions
Interventions
Group gout-prednisone subgroup:N/A
Group gout-Firsekibart subgroup:N/A
Group hyperuricemia:N/A
Sponsors
The Third Affiliated Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily signed informed consent form; 2.Age between 18 and 60 years; 3.Sex: Both male and female subjects are acceptable; 4.HUA diagnosis: Fasting serum uric acid level > 420 µmol/L on two separate occasions (applicable only to the HUA group); 5.Gout diagnosis: Meeting the 2015 ACR/EULAR gout classification criteria (applicable only to the gout group); 6.For subjects in the HUA and gout groups, CKD stage 3 (i.e., eGFR 30–59 mL/min/1.73 m²) is required; for subjects in the healthy control group, normal renal function (eGFR = 90 mL/min/1.73 m²) is required; 7.Patients in the gout group must meet any one of the following criteria: 1) Contraindication to or intolerance of NSAIDs and/or colchicine; 2) After previous acute gout attack, inadequate relief (< 50%) of joint pain and inflammatory symptoms following adequate dose and full course of standardized NSAIDs or colchicine treatment for 3–7 days; 3) Unsuitability for repeated use of systemic glucocorticoids, such as severe osteoporosis, etc; 8.Able to comply with the study or follow-up procedures;
Exclusion criteria
Exclusion criteria: 1.Use of antibiotics or antifungal agents within 30 days prior to enrollment; 2.Use of probiotic products within 2 weeks prior to enrollmen; 3.Comorbid conditions affecting intestinal microecology (such as diarrhea, inflammatory bowel disease, irritable bowel syndrome, history of gastrointestinal surgery, etc.); 4.Pregnant or lactating women; 5.Secondary hyperuricemia caused by tumors, hematological diseases, psoriasis, medications, or other reasons; 6.Severe hepatic impairment: Alanine aminotransferase and/or aspartate aminotransferase > 1.5 times the upper limit of normal, and/or total bilirubin exceeding the upper limit of normal; 7.Severe renal impairment: eGFR < 30 mL/min/1.73 m², or currently undergoing renal replacement therapy; 8.Presence of active infection (such as pulmonary tuberculosis), history of recurrent infections, or high-risk factors for infection; 9.For subjects in the gout group: 1) Hypersensitivity to vosoritide or any of its components; 2) Absolute contraindications to glucocorticoid use, such as active gastrointestinal bleeding, etc.; 3) Other conditions deemed by the investigator as unsuitable for any analgesic regimen involved in this study; 10.Judged by the investigator as unsuitable for participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum creatinine; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum IL-18;Serum IL-1beta;Gut microbiota;Serum TNF-a;eGFR;Serum uric acid; | — |
Countries
China
Contacts
Public ContactHe Yi
The Third Affiliated Hospital of Southern Medical University
Outcome results
None listed