FEbuxostat versus placebo rAndomized controlled Trial regarding reduced renal function in patients with Hyperuricemia complicated by chRonic kidney disease stage 3 (FEATHER study)
- Conditions
- chronic kidney disease, hyperuricemia
- Registration Number
- JPRN-UMIN000008343
- Lead Sponsor
- Public Health Research Foundation (PHRF)
- Brief Summary
Of 443 patients who were randomly assigned, 219 and 222 assigned to febuxostat and placebo, respectively, were included in the analysis. There was no significant difference in mean eGFR slope between the febuxostat and placebo groups (difference, 0.70; P=0.1).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 467
Not provided
(1) Uncontrolled diabetes mellitus; HbA1c 8.0% (JDS) or 8.4% (NGSP) (2) Systolic blood pressure 160 mmHg or diastolic blood pressure 100 mmHg (3) ALT or AST is more than the twice the upper limit of institutional reference range (4) Change of serum creatinine more than 50% within 12 weeks (5) Acute renal disease, nephrotic syndrome, other serious disease, on dialysis, or renal-transplant (6) Complication or history of malignant tumor (Patients were not excluded from the study when the malignant tumor is not treated within five years and if there is no recurrence.) (7) History of hypersensitivity to febuxostat (8) Intake of any of the following drug at confirmation of eligibility; mercaptopurine hydrate, azathioprine, vidarabine, didanosine (9) Intake of any of the following uric acid descent medicine within four weeks before confirmation of eligibility; allopurinol, benzbromarone, probenecid, bucolome,febuxostat (10) Beginning of dosage, change of dose or discontinued with any of the following drug within four weeks before confirmation of eligibility; losartan, fenofibrate, thiazide diuretics, loop diuretic (11) Continuous intake of salicylic acid drugs such as aspirin continuously (Patients taking low-dose aspirin [324 mg/day] were not excluded from the study.) (12) Being on hormone replacement therapy with estrogen (13) Pregnancy, nursing or planning to become pregnant during the study (14) Participation in other clinical trials within 24 weeks before informed consent (15) Judged as ineligible in the opinion of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eGFR slope(change per year,mL/min/1.73 m2/year)
- Secondary Outcome Measures
Name Time Method