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Tests treatment safety and results for Primary Gout and Hyperuricemia
Official title The Efficacy and Safety of SHR4640 Tablet Combined With 40 mg Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia
ClinicalTrials.gov ID: NCT07362355
What this study is testing
What is SHR4640 ；Febuxostat?
SHR4640 ；Febuxostat is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for primary gout and hyperuricemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- SHR4640 tablets is a highly selective and potent URAT1 inhibitors. The study is being conducted to evaluate the efficacy, and safety of SHR4640 tablet combined with 40 mg/d febuxostat tablet in reducing uric acid in subjects with primary gout and hyperuricemia The primary purpose of the study is to evaluate the efficacy and safety of the combination of SHR4640 and 40 mg/d febuxostat compared with 60 mg/d febuxostat in primary gout and hyperuricemia subjects with inadequate control on 40 mg/d febuxostat for 12 weeks.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Voluntarily signed the informed consent, understood the procedures and methods of the study, and was willing to complete the study strictly in...
- The screening age should be 18-75 years old (including both ends), male or female;
- Receive febuxostat at a stable dose of 40 mg/day for ≥6 weeks before randomization; have a fasting serum uric acid level ≥390 µmol/L at the first...
- Meet the gout classification criteria formulated by the American College of Rheumatology (ACR) in 1977 or the joint gout classification criteria...
- Body Mass Index (BMI) between 18 kg/m² and 35 kg/m².
You likely can't join if
- \- people who meet any of the following conditions will be excluded: 1\. General conditions:
- Pregnant or lactating women;
- Females of childbearing potential or males (except those whose partners are infertile) who refuse to use or use medically unapproved highly effective...
- Average daily alcohol intake exceeding 14 g for females (e.g., 145 mL of wine, 497 mL of beer, or 43 mL of low-alcohol liquor) or exceeding 28 g for...
- Drug abusers;
- people with poor compliance judged by investigators, which may affect the safety and how well it works evaluation of the study drug. 2\. The...
See the full eligibility criteria
Who can join
- Voluntarily signed the informed consent, understood the procedures and methods of the study, and was willing to complete the study strictly in accordance with the clinical trial protocol;
- The screening age should be 18-75 years old (including both ends), male or female;
- Receive febuxostat at a stable dose of 40 mg/day for ≥6 weeks before randomization; have a fasting serum uric acid level ≥390 µmol/L at the first measurement, and a repeat fasting serum uric acid level ≥360 µmol/L after...
- Meet the gout classification criteria formulated by the American College of Rheumatology (ACR) in 1977 or the joint gout classification criteria formulated by the American College of Rheumatology and the European League...
- Body Mass Index (BMI) between 18 kg/m² and 35 kg/m².
What rules you out
- \- people who meet any of the following conditions will be excluded: 1\. General conditions:
- Pregnant or lactating women;
- Females of childbearing potential or males (except those whose partners are infertile) who refuse to use or use medically unapproved highly effective contraceptive measures within 6 months (for females) or 3 months (for...
- Average daily alcohol intake exceeding 14 g for females (e.g., 145 mL of wine, 497 mL of beer, or 43 mL of low-alcohol liquor) or exceeding 28 g for males (e.g., 290 mL of wine, 994 mL of beer, or 86 mL of low-alcohol...
- Drug abusers;
- people with poor compliance judged by investigators, which may affect the safety and how well it works evaluation of the study drug. 2\. The following laboratory abnormalities within 4 weeks before randomization:
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or total bilirubin (TBIL) \> 2 times the upper limit of normal (ULN);
- Estimated glomerular filtration rate (eGFR) \< 60 mL/(min×1.73m²) calculated by the Modification of Diet in Renal Disease (MDRD) formula based on serum creatinine level;
- Glycated hemoglobin (HbA1c) ≥ 8%;
- Active hepatitis B [positive hepatitis B surface antigen (HBsAg) and hepatitis B virus deoxyribonucleic acid (HBV-DNA) exceeding the normal range], or positive anti-hepatitis C virus (HCV) antibody, or positive human...
- White blood cell count \< 3.0×10⁹/L, and/or hemoglobin \< 90 g/L, and/or platelet count \< 80×10⁹/L;
- Prolonged QTcF interval confirmed by repeated 12-lead electrocardiogram (ECG) (QTcF \> 450 ms). 3\. History of or comorbidities with any of the following:
- Hypersensitivity to SHR4640 or any component of SHR4640, or a history of intolerance or contraindication to febuxostat or citrate;
- Secondary hyperuricemia caused by tumors, chronic kidney disease, hematological diseases, drugs, or other causes;
- Other joint lesions that investigators believe may confuse gouty arthritis, such as rheumatoid arthritis, suppurative arthritis, traumatic arthritis, psoriatic arthritis, pseudogout, systemic lupus erythematosus, or...
- B-ultrasound suggesting or suspecting urinary calculi within 4 weeks before randomization;
- Gout flare within 2 weeks before randomization;
- History of active peptic ulcer within 1 year before screening and during the screening period, or active peptic ulcer at screening;
- History of xanthinuria;
- Suffering from malignant tumors, or a history of malignant tumors within 5 years before screening (except for treated non-melanoma skin cancers with no signs of recurrence and resected cervical intraepithelial...
- History of chronic or recurrent infections within 1 year before screening and during the screening period; or severe infections (including but not limited to hepatitis, sepsis, pneumonia, pyelonephritis, etc.) or...
- people requiring systemic treatment with immunosuppressants;
- Past or current moderate to severe congestive heart failure (New York Heart Association Class III or IV);
- Myocardial infarction, unstable angina pectoris, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, transient ischemic...
- Poorly controlled hypertension at screening and during the screening period [resting systolic blood pressure (SBP) ≥ 180 mmHg and/or diastolic blood pressure (DBP) ≥ 110 mmHg, confirmed by re-examination];
- Complicated with other severe or poorly controlled diseases;
- Major surgery performed within 3 months before screening and during the screening period, or failure to recover after surgery, or plan to undergo major surgery during the study;
- Blood donation (or blood loss) with a volume ≥ 400 mL, or blood transfusion received within 3 months before screening and during the screening period;
- Other conditions deemed inappropriate for participation in this study by investigators. 4\. Use of any of the following drugs or participation in clinical trials:
- Participation in any clinical trial of investigational drugs (including investigational vaccines) and use of investigational drugs within 3 months before screening or within 5 half-lives of the investigational drug...
- Participation in any clinical trial of medical devices within 3 months before screening (excluding people who failed screening);
- Use of other urate-lowering drugs (allopurinol, probenecid, benzbromarone, dotinurad, recombinant urate oxidase) within 4 weeks before screening;
- Use of drugs that interact with febuxostat (theophylline, azathioprine, mercaptopurine) within 4 weeks before screening;
- Daily aspirin dosage exceeding 100 mg or unstable dosage within 4 weeks before screening;
- Use of any diuretics within 2 weeks before randomization;
- Use of angiotensin II receptor blockers (e.g., losartan), calcium channel blockers (e.g., amlodipine), fibrate lipid-lowering drugs (e.g., fenofibrate), statin lipid-lowering drugs (e.g., atorvastatin), clofibrate...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.