chronic kidney disease patients with hyperuricemia
Conditions
Interventions
Experimental:febuxostat
Placebo Comparator:Placebo
Sponsors
Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) 18-65 years old, male or female; 2) clinical Clinical or pathological diagnosis of chronic kidney disease patients, eGFR=20-59ml/min/1.73m2 (2009EPI formula); 3) serum Serum urate (sUA) concentration=7-9mg/dl (420-540 umol/L); 4) No history of gout; 5) Within 3 months prior to enrollmentIn last 3 months before recruited into group, the patients didnt havewithout cardiovascular and cerebrovascular events: cerebrovascular diseases (Cerebral hemorrhage, Cerebral infarction, Subarachnoid hemorrhage, transient ischemic attack , etc); newly diagnosed or relapsed non fatal coronary artery diseases (myocardial infarction, unstable angina); heart failure patients who need hospitalization; arterial sclerosis patients who need hospitalization (Arterial aneurysm, arterial dissection, arteriosclerosis occlusion); 6) women Women in the reproductive period must be completely contraception in 28 days before treatment, during the treatment process and in 28 days after treatment; 7) Men must be completely contraception and prohibited donation and sperm donation during the treatment process and in 28 days after treatment; 8) All patients must be prohibited donation during the treatment process and in 28 days after treatment; 9) In addition to the subjects, prohibittingprohibiting other people taking this product; 10) Patients enrolled in the trial should sign an informed consent form, to indicate understanding the purpose and procedure of the trial, and patients volunteering to participate in the trial; 11) patients Patients have a good understanding and could coordinate with investigators for the trial.
Exclusion criteria
Exclusion criteria: 1) Uncontrolled diabetes mellitus, HbA1c=7.5%; 2) Uncontrolled hypertension, Systolic blood pressure=140mmHg or diastolic blood pressure=90mmHg; 3) obesityObesity, body mass index(BMI)> 28 Kg/m2; 4) Within 3 months prior to enrollmentIn last 3 months before recruited into group, serum creatinine of the patient fluctuate > 50%; 5) urine Urine protein>3.5g/d; 6) acute Acute renal injury, dialysis, renal transplantation; 7) Swallowing dysfunction or Cant be taken orally or can’t be digestive tract absorption dysfunctionabsorbed by the digestive tract. 8) abnormal Abnormal liver function: Total bilirubin ( TB), or AST and TB, or ALT and TB : greater than the upper limit of institutional reference range 9) abnormal Abnormal results of blood routine test: White blood cell <3×l09/L,hemoglobin <80g/L,platelet <60×l09/L; 10) active Active hepatitis B (including HBeAg or small Sanyang) or positive serum index (HBsAg or/and HBeAg or/and HBcAb), Hepatitis C, tuberculosis, HIV infection, serious fungal infections, or other severe, uncontrolled infection; 11) With Complication complication or history of malignant tumor (patients whose tumor history is more than 5 years, but not excluded from the study when the malignant tumor is not treatedwithout treating within 5 years and if there is no recurrence within 5 years can be recruited); 12) History of hypersensitivity to febuxostat; 13) Intake of any one or more of the following drugs at the confirmation of eligibility: mercaptopurine hydrate, azathioprine, vidarabine, and didanosine; 14) Intake of any one or more of the following drugs within 4 weeks before the first treatment: losartan, fenofibrate, thiazide diuretics, and loop diuretics; 15) Intake of any one or more of the following urate-lowering drugs within 4 weeks before the first treatment: allopurinol, benzbromarone, febuxostat, and probenecid; 16) Continuous intake of salicylic acid drugs, except the patient taking low-dose aspirin (100-300 mg/d) need not to be excluded from the study; 17) Need for immunosuppressive therapy (except the patient only taking prednisone=15mg/d , or the other glucocorticoid hormone in equivalent dose need not to be excluded from the study); 18) Hormone replacement therapy with estrogens; 19) Enrollment in other clinical trials within 28 days before providing informed consent; 20) Drug and alcohol abuse; 21) Unwilling or unable to contraception in the reproductive period; 22) Lactating or pregnant women; 23) Ineligibility at the investigator’s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| creatinine; | — |
Secondary
| Measure | Time frame |
|---|---|
| total mortality rate;the proportion of reaching achieving serum urate (sUA) level goal; | — |
Countries
China
Contacts
Public ContactJiang Hua Chen
Outcome results
None listed