anemia
Conditions
Interventions
High dose group:6mg/d Ennadustat
Low dose group:4mg/d Ennadustat
Sponsors
Renji Hospital, Shanghai Jiaotong University, School Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the experiment and sign the informed consent form 2. Age range is 18-75 years old (including threshold), with no gender restrictions 3. The glomerular filtration rate (eGFR) value calculated by the CKD-EPI formula is less than 60 mL/min/1.73m2 for non dialysis chronic kidney disease patients with KDIGO chronic kidney disease stages 3-5 4. Diagnose renal anemia, with a screening period hemoglobin value of <= 80g/L for subjects with renal anemia 5. Have not received treatment with erythropoietic stimulants (ESA) or HIF-PH inhibitors for at least 2 weeks prior to randomization, or have not received treatment with long-acting EPO or peptide preparations for at least 4 weeks prior to randomization 6. Researchers determine that alternative treatments such as dialysis or kidney transplantation are not necessary throughout the entire trial process 7. The dosage of iron therapy remained stable for the first 2 weeks before randomization
Exclusion criteria
Exclusion criteria: 1. Poor blood pressure control after regular drug treatment for more than 4 weeks before screening, with systolic blood pressure (SBP)>160mmHg or diastolic blood pressure (DBP)>100mmHg during screening 2. Patients with severe complications of the liver and gallbladder system (AST or ALT>2.5 times the upper limit of normal, total bilirubin>1.5 times the upper limit of normal) 3. Patients with absolute iron deficiency (ferritin= 800 pg/mL) 10. Patients with positive HIV, HCV, or Treponema pallidum antibodies, or HBsAg positive and HBV-DNA >= 1000U/mL 11. Severe active infections (such as active tuberculosis, fungal infections, etc.), systemic blood diseases (such as myelodysplastic syndrome, aplastic anemia), hemolytic anemia, or hemorrhagic anemia 12. 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 13. History of severe drug allergies (such as anaphylactic shock) or allergies to other HIF-PH inhibitors 14. History of drug or alcohol abuse in the past two years 15. Have participated in any clinical trials of other drugs or medical devices within the previous month before screening, or have participated in any clinical trials of drugs or medical devices during the planned trial process 16. Pregnant and lactating women 17. Researchers believe that it may pose safety risks to the subjects of this trial, may confuse efficacy or safety evaluations, or may interfere with the medical conditions of the subjects participating in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Indicators of iron metabolism;Quality of life; | — |
Countries
China
Contacts
Public ContactXiajing Che
Renji Hospital, Shanghai Jiaotong University, School Medicine
Outcome results
None listed