Maintenance Hemodialysis with Renal Anemia
Conditions
Interventions
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years. 2. After the subjects listened to the explanation of the nature of the study and had the opportunity to ask questions, the subjects voluntarily signed an informed consent form approved by the ethics committee and dated it. 3. ESRD chronic kidney disease with adequate hemodialysis for at least 16 weeks before day 1 administration: vascular access must be through a natural arteriovenous fistula or graft or permanent tunnel catheterization. 4. In accordance with the diagnostic criteria of renal anemia, the level of hemoglobin is greater than or equal to 70g/L. 5. The subjects received at least 12 weeks of intravenous or subcutaneous stable dose of Epoetin Alfa before receiving Roxadustat on the first day. 6. Clear mind, can cooperate with blood collection and carbon monoxide breath collection and testing.
Exclusion criteria
Exclusion criteria: 1. There is any evidence of clinically significant infection or active potential infection. 2. Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (anti-HCVAb). 3. Chronic liver disease. 4. Chronic lung disease. 5. Congestive heart failure of III or IV grade of cardiac function of New York College of Cardiology. 6. Myocardial infarction, acute coronary syndrome, stroke, convulsion or thromboembolism events (such as deep venous thrombosis or pulmonary embolism) within 52 weeks before administration on the first day. 7. History of malignant tumors, except in the following cases: tumors determined to be cured or relieved for 5 years, radically resected basal cell or squamous cell carcinoma of the skin, or carcinoma in situ at any site. 8. Active bleeding 9. Diseases that may affect the lifespan of red blood cells (such as connective tissue disease, hemolytic anemia, hematological diseases). 10. The duration of maintenance hemodialysis is expected to be less than 6 months, such as renal transplantation, abdominal dialysis and life expectancy less than 6 months. 11. Elective surgery that is expected to lead to significant blood loss during the study period. 12. Blood transfusion or expected need for blood transfusion within 12 weeks before administration on the first day. 13. Smokers and those who have been living around smokers for a long time and cannot be avoided temporarily. 14. Those who are unable to hold their breath and exhale according to the carbon monoxide breath collection standard. 15. Use experimental drugs or treatments during this study, participate in experimental intervention studies, or expect residual effects of experimental treatments. 16. Women during pregnancy or lactation. 17. Medical conditions that the researchers believe may pose a threat to the safety of participants in this trial, may confuse effectiveness and safety evaluation, or may interfere with subjects' participation in the trial. 18. Use Roxadustat within 12 weeks before the first day of administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erythrocyte lifespan;Erythrocyte function;Blood routine; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver function;Biochemistry;Blood pressure;Heart rate;Total iron binding capacity;Glycosylated hemoglobin;C-reactive protein;Parathyroid hormone;Serum ferritin;Transferrin saturation;Rate of eryptosis; | — |
Countries
China
Contacts
Public ContactRong Wang
Shandong Provincial Hospital
Outcome results
None listed