Anemia in CKD
Conditions
Interventions
Experimental group:Roxadustat (Airuizhuo)
Control group:Yibiao
Sponsors
Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years; 2. End-stage renal disease and maintenance hemodialysis for at least 16 weeks; 3. Receive a stable dose of EPO for 6 weeks, and the dose is < 15000 IU/week; 4. The average Hb level is 11.0~13.0 g/dL (the last two evaluations); 5. Vascular access: internal fistula or long-term hemodialysis catheter; 6. Weight between 45-100 kg; 7.ALT or AST < 1.5 times the upper limit, bilirubin is normal.
Exclusion criteria
Exclusion criteria: 1. Severe infection; 2. NYHA class III~IV heart failure; 3. Any of the following infection indicators are positive: HBVsAg, anti-HCV antibody, HIV, syphilis; 4. Myocardial infarction or stroke occurred within 52 weeks before enrollment; 5. Uncontrolled high blood pressure; 6. Malignant tumors, except those that have been cured, have been in remission for > 5 years, or carcinoma in situ; 7. Previously or currently suffering from multiple myeloma, aplastic anemia, myelodysplastic syndrome or hereditary hematopoietic system diseases; 8. Gastrointestinal bleeding with clinical significance; 9. Breast-feeding or pregnant women, patients with recent family planning; 10. Use of hormones or immunosuppressants; 11. Using drugs that affect muscles or suffering from diseases that affect muscle strength and joint mobility; 12. Restricted joint or muscle activity due to previous trauma or surgery; 13. Planning orthopedic surgery; 14. Any researcher believes that it may pose a safety risk to the subjects of this study, may affect the efficacy or safety evaluation, or may interfere with the medical condition of the study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Grip strength;Walk speed;Subjective global assessment score;Skeletal muscle index;Lean mass index;Skeletal muscle mass; | — |
Countries
China
Contacts
Public ContactWei Ding
Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed