Chronic kidney disease with hyperuricemia and hypertension
Conditions
Interventions
Febuxostat group: Patients take febuxostat by oral administration for 52 weeks (approximately one year). The beginning dosage of the febuxostat is 10 mg/day. The dose is increased to 20 mg /day af
Sponsors
Dialysis Unit, University Hospital of the Ryukyus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Serum uric acid >7.0 mg/dL 2) Patients with hypertension defined as blood pressure measurements of equal or more than 140 mm Hg systolic and/or equal or more than 90 mm Hg diastolic or treatment with antihypertensive agents. No changes in prescription of antihypertensive agent 8 weeks before initiating the study drug. 3) CKD stage 3a and 3b 4) Age equal to or more than 20 years at obtaining informed consent 5) Outpatient 6) No history of gout 7) Obtained written informed consent from the patient for participation to the study
Exclusion criteria
Exclusion criteria: 1) History of hypersensitivity to febuxostat or benzbromarone 2) AST or ALT is more than twice the upper limit of institutional normal range 3) eGFR <30ml/min/1.73m2 or dialysis patients. 4) Under treatment with thiazide diuretics or loop diuretics 5) History of treatment with urate lowering drugs within 2 weeks before determination of eligibility 6) History of coronary heart disease within 3 month before determination of eligibility 7) Patients with neoplasm, History of neoplasm except for the cured patients without recurrence within 5 years before determination of eligibility 8) Under treatment with the following: mercaptopurine,azathioprine, pyrazinamide, ethanbutol 9) Under treatment with warfarin 10) Women who are or may be pregnant, or brest-feeding 11) Participants of other clinical trials within 6 month before determination of eligibility 12) Urolithiasis 13) A patient who are judged inadequate for enrollment by an attending physician 14) A patient whose serum uric acid level is equal to or less than 7 mg/dl at Visit2 after randomization 15) A patient has been suffered from any of following: acute myocardial infarction, acute coronary syndrome, patients undergoing percutaneous coronary intervention or coronary artery bypass grafting, vetricular tachycarida, mutifocal ventricular arrhythmia and acute heart failure within three months before the eligibility assessment. This exclusion criteria was added since recent study suggested febuxostat may be associated with increased cardiovascular mortality compared with allopurinol among gout patients with major cardiovascular disease (N Engl J Med 2018;378:1200-10)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of change in estimated GFR from baseline to 52 week (%/52week and ml/min/1/73m2/52w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Rate of change in eGFR from the baseline to 8 weeks 2) Rate of change in office blood pressure from the baseline to 8 and 52 weeks 3) Difference in rate of change in estimated GFR before(Visit 1 to 2) and after treatment (Visit 2 to 4) 4) Rate of change in serum uric acid from baseline to 8 and 52 weeks and achievement rate of serum uric acid concentration less than 6 mg/dl at 8 and 52 weeks 5) Rate of change in urinary albumin-to-creatine ratio from baseline to 8 and 52 weeks 6) Rate of change in urinary pH from baseline to 8 and 52 weeks 7) Rate of change in serum xanthine oxidase activity from baseline to 8 and 52 weeks 8) Rate of change in high sensitive C reactive protein from baseline to 8 and 52 weeks 9) Rate of change in 8-OHdG (8-hydroxy-2-deoxyguanosine) from baseline to 8 and 52 weeks 10) Rate of change in urinary angiotensinogen from baseline to 8 and 52 weeks 11) Rate of change in L type free fatty acid binding protein(L-FABP) from baseline to 8 and 52 weeks 12) Rate of change in estimated GFR from baseline to 52 weeks stratified by basal urinary albumin-to-creatinine ratio (300mg/gCr) or estimated GFR (45ml/min/1.73m2) | — |
Countries
Japan
Contacts
Public ContactKentaro Kohagura
University hospital of the Ryukyus Dialysis Unit
Outcome results
None listed