Renal anemia
Conditions
Interventions
experimental group:double-blind treatment of Desidustat Tabletst for 8 weeks, then open treatment with Desidustat Tablets for 44 weeks
Placebo group:double-blind treatment of Placebo for 8 weeks, then open treatment with Desidustat Tablets for 44 weeks
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Have the ability to understand and voluntarily sign the informed consent; 2. Male or female, aged 18 to 80 (including 18 and 80); 3. CKD-EPI formula calculated glomerular filtration rate (eGFR) value < 60 mL/min/1.73 m^2 (KDOQI chronic kidney disease 3, 4 or 5) confirmed chronic kidney disease anemia subjects who did not receive dialysis By; 4. The average hemoglobin obtained in the last two times (at least 7 days apart) during the screening period is 70-100g/L (including 70g/L, excluding 100g/L); 5. Weight 40-100kg (including boundary value); 6. Subjects who did not undergo dialysis during the study period and are not expected to start dialysis; 7. Subjects who have not been treated with erythropoietic agents (ESA) within 6 weeks before randomization; 8. Subjects who did not use any traditional Chinese medicine preparations for anemia within 2 weeks before randomization; 9.100ng/mL<=serum ferritin<=800ng/mL or 20%<transferrin saturation<=50%; 10. No folic acid or vitamin B12 deficiency.
Exclusion criteria
Exclusion criteria: 1. Blood transfusion or red blood cell transfusion within 8 weeks before randomization; 2. History of previous or concurrent malignant tumors, except for the following cases: tumors determined to be cured or in remission for 5 years, skin basal cell or squamous cell carcinomas that have been radically removed, or carcinoma in situ of any site; 3. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (anti-HCV Ab); 4. Patients with serious complications of the hepatobiliary system (AST or ALT>2.5 ULN, or total blood bilirubin>1.5 ULN); 5. Serum potassium >= 5.5mmol/L; 6. Severe active infection (such as active tuberculosis, fungal infection, etc.) within 1 week before randomization; 7. Previous organ transplantation or scheduled organ transplantation; 8. Those who have undergone surgery with massive bleeding within 90 days before randomization, or have undergone surgery with a small amount of bleeding within 30 days, or plan to undergo surgery during the study period; 9. Have an inability to swallow tablets or a disease that severely affects gastrointestinal function and/or inhibits absorption in the small intestine, such as malabsorption syndrome, resection of the small intestine, or poorly controlled inflammatory bowel disease affecting the small intestine; 10. There is a history of hereditary blood diseases, or systemic blood diseases (such as myelodysplastic syndrome, aplastic anemia), or hemolytic anemia, or hemorrhagic anemia, or other known causes of anemia other than chronic kidney disease; 11. The presence of bleeding disorders or bleeding clinical conditions (such as gastrointestinal bleeding) that may increase the risk of life-threatening bleeding; 12. Acute myocardial infarction, transient ischemic attack, cerebral infarction or pulmonary embolism, deep vein thrombosis, etc. occurred within 6 months before randomization; 13. Current cardiovascular disease of significant clinical significance, such as uncontrolled arrhythmia, congestive heart failure, unstable angina, any grade 3 or 4 heart disease as defined by the New York Heart Association functional classification; 14. History of hypersensitivity or hypersensitivity reactions to study drugs or drugs of similar structure; 15. History of severe alcohol abuse (average weekly drinking of more than 14 units of alcohol (1 unit = 360 mL of beer or 45 mL of 40% liquor or 150 mL of wine)) or drug use within 1 year before randomization; 16. Received immunosuppressive therapy or systemic steroid therapy within 3 months before screening; 17. Difficulty in venous blood collection or physical condition that cannot bear blood collection; 18. Previously received roxadustat capsules or any hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) treatment; 19. Participated in any drug or device clinical research other than the current trial within 3 months before randomization (note: only signed informed, subjects without other clinical trial interventions are acceptable); 20. The subject donated 350 ml or more of blood within 3 months before randomization; 21. Existing chronic inflammatory diseases other than glomerulonephritis that may affect erythropoiesis, such as rheumatoid arthritis (RA), celiac disease, ulcerative colitis (UC), Crohn's disease, systemic lupus erythematosus ( SLE), etc.; 22. Diabetic patients, glycosylated hemoglobin (HbA1c)> 9% within 3 months before random
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference between the mean Hb concentration level; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety and tolerability;Proportion of hemoglobin responsive subjects;Time to reach the target range Hb level;Percentage of time within target Hb;Number of subjects requiring remedial treatment by week 9; | — |
Countries
China
Contacts
Public ContactLi Xuemei
Chinese Academy of Medical Sciences Peking Union Medical College Hospital
Outcome results
None listed