Diabetic nephropathy
Conditions
Interventions
Experimental group:Treatment with Enarodustat
Control group:Treatment with Yibi Bio medication
Sponsors
The Second Affiliated Hospital Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age range: 18-75 years old (including threshold), male or female not limited; 2.Meet the diagnosis of diabetes nephropathy: under the condition that diabetes is identified as the cause of kidney damage and chronic kidney disease caused by other reasons is excluded, at least one of the following shall be available: a. Under the condition that interference factors are excluded, UACR >= 30mg/g or UAER >= 30mg/24h (>= 20ug/min) shall be available at least twice in three tests within 3-6 months; b. EGFR20% or ferritin>100ng/ml; 6.Hemoglobin level: (1) Not receiving erythropoietic stimulation agent (ESA) treatment for at least 8 weeks prior to randomization. (2) The central laboratory hemoglobin values between two visits (at least 6 days apart) are >= 80 g/L and<105 g/L, and the absolute value change between the two visits is<10 g/L.
Exclusion criteria
Exclusion criteria: 1.Poor blood pressure control (>160/100mmHg); Poor blood pressure control after regular drug treatment for more than 4 weeks prior to screening, with systolic blood pressure (SBP)>160mmHg or diastolic blood pressure (DBP)>100mmHg during screening; 2.Severe liver and gallbladder diseases (AST or ALT>2.5 times the upper limit of normal, total bilirubin>1.5 times the upper limit of normal); 3.Acute kidney injury occurred within the 12 weeks prior to screening; 4.Heart failure (heart function level IV) or unstable angina pectoris; 5.Has experienced myocardial infarction, transient ischemic attack, cerebral infarction, pulmonary embolism, or venous thromboembolism within the 6 months prior to randomization; 6.Received blood transfusion or red blood cell transfusion within the past 3 months prior to screening; 7.Received treatment with protein synthesis metabolic hormones, testosterone heptanoate, or metoprolol within the first 3 months of screening; 8.Severe hyperparathyroidism (iPTH >= 500 pg/mL); 9.Serious infections (such as active tuberculosis, fungal infections, etc.); 10.Systemic hematological disorders (such as myelodysplastic syndrome, aplastic anemia) or hemolytic anemia; 11.Anemia caused by bleeding lesions; 12.Anemia suspected to be caused by non communicable chronic inflammatory diseases (excluding glomerulonephritis) (such as systemic lupus erythematosus, rheumatoid arthritis, celiac disease, etc.); 13.Life expectancy<1 year; 14.Pregnant and lactating women; 15.During the period from signing informed consent to the end of the medication study, women of childbearing age or men with reproductive age partners who do not agree to use effective contraception (effective contraceptive methods include transdermal patches, oral medication, implantable or injectable contraceptives, abstinence or contraceptive surgery); 16.Serious mental illness; 17.History of malignant tumors, except for tumors confirmed to be cured or have been relieved for 5 years, skin basal cell or squamous cell carcinoma that has been surgically removed, or carcinoma in situ in any location; 18.History of severe drug allergies (such as anaphylactic shock) or allergies to other HIF-PH inhibitors; 19.History of drug or alcohol abuse in the past two years; 20.Have participated in any clinical trials of other drugs or medical devices within the previous 3 months of screening, or have participated in any clinical trials of drugs or medical devices during the planned trial process; 21.Received treatment with Enadulostat or other HIF-PH inhibitors before screening; 22.Patients who are HIV, HCV, or Treponema pallidum antibody positive, or HBsAg positive with HBV DNA = 1000 U/mL; 23.The researchers believe that there may be safety risks to the subjects of this trial, confusion in efficacy or safety evaluation, or other medical conditions that may interfere with subject participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hb; | — |
Countries
China
Contacts
Public ContactKunling Ma
The Second Affiliated Hospital Zhejiang University School of Medicine
Outcome results
None listed