Chronic Kidney Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male or female, aged 18-70 years; 2) Clinically diagnosed as chronic kidney disease (CKD) estimated glomerular filtration rate (eGFR) = 20-59ml/min/1.73m2 (2009EPI formula); 3) Blood uric acid = 7-9mg/dl (420-540µmol/L); 4) History of previous episodes without gout; 5) No cardiovascular and cerebrovascular events occurred within 3 months before enrollment: cerebrovascular disease (cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, etc., transient ischemic attack); new or recurrent non-fatal Coronary artery disease (MI, unstable angina); heart failure requiring hospitalization; 6) Patients participating in the trial should sign an informed consent form indicating that they have understood the purpose of the trial and the test procedures, and that the patient voluntarily participated in the trial.
Exclusion criteria
Exclusion criteria: 1) Poor glycemic control, HbA1c = 7.5%; 2) Uncontrolled blood pressure: systolic blood pressure = 140mmHg or diastolic blood pressure = 90mmHg; 3) Blood creatinine levels fluctuate more than 50% within 3 months before enrollment; 4) urinary protein or urinary protein / creatinine ratio> 3.5g/d; 5) Acute kidney injury, dialysis, renal transplantation; 6) Those who cannot take oral medicines or cannot take drugs through the digestive tract; 7) abnormal liver function: total bilirubin exceeds the upper limit of normal, or aspartate aminotransferase (AST) exceeds the upper limit of normal, or alanine aminotransferase (ALT) exceeds the upper limit of normal; 8) abnormal blood routines: white blood cells <3×l0^9/L, hemoglobin <80 g/L, platelets <60 ×l0^9/L; 9) Patients with a history of cancer (with a history of more than 5 years and no tumor-related treatment within 5 years, no evidence of recurrence may be included); 10) Allergic to marine fish protein peptides; 11) Simultaneously taking mercaptopurine hydrate, azathioprine, vidarabine, and lidocalcin; 12) Thiazide diuretics and psoriasis diuretics were administered within 2 weeks before the first treatment of this product; 13) Take allopurinol, benzbromarone, febuxostat, probenecid within 2 weeks before the first treatment of this product; 14) long-term use of salicylic acid drugs, in addition to low-dose aspirin (100-300 mg/d); 15) need immunosuppressive therapy (single use of prednisone = 15 mg/d, or other equal amount of glucocorticoid can be included); 16) Estrogen replacement therapy; 17) Received trial drug treatment within 28 days before receiving the first treatment of this product; 18) Drug abusers or alcoholics; 19) Reproductive patients are unwilling or unable to contraceptive; 20) Pregnancy or breastfeeding; 21) Researchers consider it inappropriate to be selected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| renal and cardiocerebral events; | — |
Secondary
| Measure | Time frame |
|---|---|
| all-cause mortality;Uric acid compliance rate (proportion of patients with serum uric acid <6 mg/dl (360 µmol/L)); | — |
Countries
China
Contacts
the Third Affiliated Hospital of Sun Yat-sen University