renal anemia
Conditions
Interventions
low dose oral iron group:Oral ferrous succinate sustained-release tablets 200mg, elemental iron 70mg
high dose oral iron group:Oral ferrous succinate sustained-release tablets 600mg, elemental iron 210mg
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with stage 5 chronic kidney disease who received maintenance hemodialysis > = 3 months; 2. Age 18-75 (inclusive); 3. Regular hemodialysis treatment > =3 times a week, spKt/V>=1.2; 4. The hemoglobin concentration before dialysis during screening and introduction (week -1) is >=9.0g/dL and does not exceed 13 g/dL; 5. Two detection values during screening and lead-in period (week -1), transferrin saturation (TSAT) before dialysis were 15-45%; 6. Two detection values during screening and introduction period (week -1), ferritin before dialysis was 200~500µg/L; 7. Current hemodialysis with arteriovenous fistula, arteriovenous catheter or indwelling catheter (internal jugular vein or subclavian vein); 8. Sign informed consent;
Exclusion criteria
Exclusion criteria: 1. New York Heart Association class III or IV congestive heart failure with myocardial infarction, acute coronary syndrome, stroke, epilepsy, or thrombotic/thromboembolic events (such as deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization; 2. History of chronic liver disease (e.g., chronic infectious hepatitis, chronic autoimmune liver disease, cirrhosis or liver fibrosis); 3. Known hereditary blood disorders such as thalassemia, sickle cell anemia, history of pure red cell aplasia, or other known causes of non-CKD anemia; 4. Known history of kidney, prostate, breast or any other malignant tumor, except for the following cancers: cancers that have been determined to have been cured or in remission for more than 5 years, basal cell or squamous cell skin cancer that has been radically removed, cervical cancer in situ, or resected colon polyps; 5. Known chronic inflammatory diseases, such as rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis or inflammatory bowel disease; 6. Active bleeding in areas other than known arterial venous fistulas or artificial fistulas; 7. It is known that a surgery will be scheduled during the study that may result in significant blood loss; 8. Known various forms of bleeding disorders; 9. Determination that the patient has one kidney as a living donor transplant kidney (it is not necessary to exclude patients waiting for transplantation from a deceased donor); 10. Pregnant or lactating women; 11. Known hypersensitivity to the test drug or any of its components; 12. Any medical condition that the investigator believes may pose a safety risk to the patients in this study, including active, clinically significant infections; 13. Uncontrolled hypertension at randomization (systolic blood pressure = 180 mmHg or diastolic blood pressure =100 mmHg repeatedly measured before dialysis in hemodialysis patients); 14. Received a total of more than 400 mg of intravenous iron within 4 weeks prior to screening; received any dose of IV iron within 4 weeks prior to randomization; 15. Receiving red blood cell or whole blood transfusion within 4 weeks prior to randomization; 16. Serum albumin < 30 g/L during screening; 17. Serum vitamin B12 or folate levels below the lower limit of normal at screening; 18. Have any active infection requiring antibiotic therapy within 4 weeks prior to randomization; 19. AST or ALT level at screening is 2 times higher than the upper limit of normal; 20. Participated in a trial of a medicinal drug within 30 days prior to screening; 21. Any other medical, mental, or personal, social status that the investigator believes may affect the patient's signing of informed consent, adherence to protocols, or completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in hemoglobin from baseline to end of treatment;Percentage of hemoglobin <90 g/L; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in hemoglobin from baseline every 4 weeks;Percentage of Ferritin change from baseline every 4 weeks and at the end of treatment (including early termination);Percentage of hemoglobin>130 g/L; | — |
Countries
China
Contacts
Public ContactChen, Yuqing
Peking University First Hospital
Outcome results
None listed