chronic kidney disease, hyperuricemia
Conditions
Interventions
Febuxostat group: Patients take febuxostat by oral administration for 108 weeks (approximately two years). The beginning dosage of study drug (febuxostat) is one 10 mg tablet/day. The study drug
Sponsors
Public Health Research Foundation (PHRF)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age 20 years-old at informed consent (2) Patients with hyperuricaemia; serum uric acid >7.0 and 10.0 mg/dL (3) eGFR 30 and <60 mL/min/1.73 m2 (CKD stage 3a and 3b) (4) No history of gout (5) Obtained written informed consent from the patient for the study participation
Exclusion criteria
Exclusion criteria: (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| eGFR slope(change per year,mL/min/1.73 m2/year) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Changes of eGFR from the baseline to 108 weeks: To evaluate the amount of change (mL/min/1.73 m2) and the rate of change (%) of eGFR from the baseline to 24, 48, 72, and 108 weeks. (2) Changes of the serum uric acid from the baseline to 108 weeks: To evaluate the amount of change (mg/dL) and the rate of change (%) of serum uric acid from the baseline to 108 weeks. (3) The achievement of serum uric acid level lower than 6.0 mg/dL (4) Occurence of events indicating the deterioration of renal functions: Induction of dialysis and evaluation of the doubling of serum creatinine level. (5) Changes of various markers from the baseline to 108 weeks i.e. exploratory examinations of the following markers of hyperuricaemia treatment for CKD patients. Renal function (serum cystatin C), oxidative stress marker (urinary 8-OHdG, urinary L-FABP), inflammatory marker (serum CRP), cardiovascular events (12-lead electrocardiogram, serum NT-pro-BNP, the albumin urine / creatinine ratio) (6) Incidence of gouty arthritis (7) Incidence of adverse event | — |
Countries
Japan
Contacts
Public ContactYoji Mitadera
Public Health Research Foundation (PHRF) Comprehensive Support Project for Clinical Research of Lifestyle-Related Disease (CSP-LD)
Outcome results
None listed