Hyperuricemia patients with chronic kidney disease G3a, G3b
Conditions
Interventions
Change of hyperuricemia drugs from allopurinol to febuxostat and administration of febuxostat for a period of 48 weeks
Sponsors
Department of Nephrology and Hypertension, Kawasaki Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Estimated glomerular filtration rate (ml/min/1.73m2) is more than 30 and less than 60. 2) Serum uric acid level has not lowered at less than 7.0mg/dl in two consecutive tests before checking the eligibility, when the patient has been treated by less than 100mg/day allopurinol. 3) Serum uric acid level has not lowered at less than 6.0mg/dl on the above condition in patients with the past history of gout or hypertension). 4) Patients with the informed consent to this study
Exclusion criteria
Exclusion criteria: 1) Patients treated by febuxostat currently or within 24 weeks before checking the eligibility 2) Patients with past hypersensitivity to febuxostat 3) Past histories of gout or urolithiasis within 24 weeks before checking the eligibility 4) Patients with diabetes controlled insufficiently (HbA1c level is more than 8.4%) 5) Patients whose systolic or diastolic blood pressure show more than 160mmHg or more than 100mmHg, respectively 6) Patients whose AST or ALT show twice more than the upper limit of reference values 7) Past hospitalization within 24 weeks before checking the eligibility 8) Patients with current or past malignant tumor However, patients who have not been treated for malignant tumor within 5 years before checking the eligibility and show no recurrence when checking the eligibility are not excluded. 9) Patients with severe cardiovascular diseases 10) Patients currently treated for inflammatory or consumptive diseases 11) Patients currently treated for acute renal failure, active nephritis or nephrotic syndrome 12) Patients treated by steroids or immunosuppressive agents 13) Patients treated by one of the below drugs when checking the eligibility Mercaptopurine hydrate, azathioprine, vidarabine, didanosine 14) Patients with administration, dose change or discontinuance of one of the below drugs within 4 weeks before checking the eligibility Losartan, fenofibrate, thiazide or loop diuretic 15) Patients currently treated by salicylate drugs However, patients treated by low-dose aspirin (less than 324mg/day) are not excluded. 16) Patients with hormone replacement therapy by estrogen 17) Patients who have participated in the other clinical study (trial) within 24 weeks before checking the eligibility 18) Female in current or expected pregnancy 19) Patients judged as unsuitable for participating in this study by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of the below parameters 1) Serum uric acid level 2) Indexes of arteriosclerosis (cardio-ankle vascular index, carotid intima-media thickness) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes of the below parameters Systolic/diastolic blood pressure, estimated glomerular filtration rate, cystatin C, C-reactive protein, urinary protein/albumin excretion 2) Achievement ratio of less than 7.0mg/dl in serum uric acid level (Achievement ratio of less than 6.0mg/dl in patients with the past history of gout or hypertension) 3) Incidence of gout/urolithiasis 4) Incidence of cardio-vascular diseases 5) Incidence of dialysis therapy 6) Incidence of detrimental events | — |
Countries
Japan
Contacts
Public ContactTamehachi Namikoshi
Kawasaki Medical School Department of Nephrology and Hypertension
Outcome results
None listed