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Effectiveness and Safety of IL-1 Inhibitors in Patients with Gout and Chronic Kidney Disease: A Prospective Multicenter Randomized Controlled Trial

Effectiveness and Safety of IL-1 Inhibitors in Patients with Gout and Chronic Kidney Disease: A Prospective Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121674
Enrollment
Unknown
Registered
2026-04-01
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout combined with chronic kidney disease

Interventions

IL-1 Inhibitor Anti-inflammatory + Conventional Urate-Lowering Therapy Group:IL-1 Inhibitor Anti-inflammatory + Febuxostat 40 mg qd Urate-Lowering Therapy
Conventional Urate-Lowering Therapy Group Only:Febuxostat 40 mg qd for Urate-Lowering

Sponsors

SHANGHAI TENTH PEOPLES HOSPITAL
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1 Voluntarily sign the informed consent form before the start of the activities related to this trial, and be able to understand the procedures and methods of this trial, and be willing to strictly follow the clinical trial protocol to complete this trial; 2 Age between 18 and 75 years old (inclusive of both ends, based on the date of signing the informed consent form , regardless of gender; 3 At the time of enrollment, clearly diagnosed with gout (in accordance with the 2015 ACR/EULAR gout diagnosis criteria , and in the intermission period (patients have not experienced gout attacks for at least the past two weeks ; and have not used uric acid-lowering drugs for the past 4 weeks. 4 Patients with proteinuria (total 24-hour urine protein > 0.15g or (and UACR > 30 mg/g ; 5 Chronic kidney disease (CKD stage 3 or below: eGFR >= 60 mL/min/1.73m^2; 6 Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1 Secondary gout (such as after organ transplantation or due to hematological diseases ; 2 Severe cardiovascular or cerebrovascular diseases, malignant tumors (except for cured skin basal cell carcinoma or cervical carcinoma in situ ; 3 Currently experiencing active infection; 4 Have used other biologics or immunosuppressants within the last 3 months; 5 Have had a drug allergy; 6 Pregnant, breastfeeding, or planning to become pregnant; 7 Abnormal laboratory test results during screening: A. Abnormal white blood cell count or absolute neutrophil count with clinical significance; B. Total bilirubin > 1.5 times the upper limit of normal (ULN , alanine aminotransferase (AST > 3 times ULN, aspartate aminotransferase (ALT > 3 times ULN.

Design outcomes

Primary

MeasureTime frame
24-hour urine protein and creatinine;

Secondary

MeasureTime frame
Changes in urinary protein levels between the two groups after 24 weeks;Improvement of proteinuria at 48 weeks;

Countries

China

Contacts

Public ContactHaibing Chen

SHANGHAI TENTH PEOPLES HOSPITAL

18930173813@163.com+86 21 6630 0000

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026