Patients with CKD stage G4 (KDIGO 2012) and hyperuricemia (7.0mg/dl<
Conditions
Interventions
Intensive treatment group: patients are administered febuxostat to reduce serum UA levels below 6 mg/dL during 24 months observation period. Initial dose is 20 mg/dL. The dose of febuxostat can be in
UA levels are controlled in between 7 and 10 mg/dL with conventional drugs during 24 months observation period.
Sponsors
National Hospital Organization Kumamoto Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)15mL/min/1.73m2 <= eGFR < 30 mL/min/1.73m2 (2)the serum UA levels are higher than 7.0 mg/dL
Exclusion criteria
Exclusion criteria: (1)Patients who have active inflammatory diseases, active cerebro-cardiovascular diseases, and gastrointestinal diseases. (2)severe hypertension defined as systolic blood pressure higher than 180mmHg or diastolic blood pressure higher than 110mmHg (3)Uncontrolled diabetes: HbA1c > 8% (NGSP) (4)Hyperkalemia: K > 6.0 mEq/L (5)history of AKI over stage 2 within recent 3 months. (6)Past history of renal transplantation (7)Liver dysfunction: ASL or ALT levels more than three times as normal limit. (8)Patients who are under treatment with mercaptopurine or azathioprine. (9)Patients who have allergy for the drugs used in this trial. (10)Patients who are pregnant, or how have possibility or willing of pregnancy. (11)Patients who are breast-feeding. (12)Patients with malignancy (13)post-renal kidney diseases (14)Patients who have gout attacks within recent one month (15)Patients who are judged by the participating doctors as inappropriate participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the changes in eGFR levels between before and after the drug intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| the changes in parameters listed below between before and after the drug intervention 1) serum UA levels 2) serum high-sensitive CRP levels 3) levels of albuminuria 4) urinary 8-OHdG levels 5) urinary L-FABP levels End-stage kidney diseases requiring renal replacement therapy Cardiovascular events Any serious adverse events considered to be related to the drug intervention | — |
Countries
Japan
Contacts
Public ContactKengo Kajiwara
National Hospital Organization Kumamoto Medical Center Division of Nephrology
Outcome results
None listed