Maintenance Hemodialysis Patients
Conditions
Interventions
experimental group:Two capsules (0.15 g/capsule) of Hongyuanda polysaccharide iron capsules were taken daily for 24 week
control group:Subjects were infused with 100 mg of sucrose iron formulation every two weeks
Sponsors
Renji Hospital School Affiliated to Medicine Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, gender is not limited; 2. Maintenance hemodialysis patients ( >= 3 months), dialysis 3 times a week; 3. Patients with hemoglobin concentration (Hb) 110-130g / L (excluding 130g / L); 4. With transferrin saturation (TSAT) 20-50% (without boundary value); 5. With serum ferritin (SF) 200-500 µg / L (without boundary value); 6. Patients who had been treated with recombinant human erythropoietin (EPO) and iron within 12 weeks before enrollment; 7. Patients who voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Iron allergy, history of allergy to test drugs or intolerance; 2. Suspected of being pure red aplastic anemia and hematopoietic and hemolytic diseases; 3. Acute and chronic bleeding; 4. Blood albumin 10 mg / L; 6. With severe secondary hyperparathyroidism (iPTH >= 800pg / ml); 7. With severe cardiac insufficiency (NYHA class 3 or higher) and poorly controlled hypertension (systolic blood pressure >= 180mmHg or diastolic blood pressure >= 100mmHg); 8. With severe liver disease (ALT, AST, and TBIL >= 2 times normal upper limit) or hepatitis B surface antigen positive, or hepatitis C antibody positive; 9. With malignant tumors; 10. With more serious bacterial infections or viral infections occurred within 1 month; 11. With a history of blood transfusion within 1 month; 12. Planned admission or planned kidney transplantation during the study period; 13. Have a history of chronic alcohol abuse, drug abuse, or any factors that affect compliance; 14. Pregnant or breast-feeding women; 15. The estimated life expectancy is less than 12 months; 16. Patients who have participated in other clinical trials or are currently participating in other clinical trials in the last three months; 17. Patients with gastric and duodenal ulcer and ulcerative colitis 18. The situation that the investigator believes may affect the compliance of the subject or affect the outcome of the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transferrin saturation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Transferrin saturation;The values of Hb, SF and hsCRP;The cost of the drug (including the cost of recombinant EPO and iron);The score of EQSD-5L;The indexes of oxidative stress were MDA, SOD and GSH-Px; | — |
Countries
China
Contacts
Public ContactNi Zhaohui
Renji Hospital School Affiliated to Medicine Shanghai Jiaotong University
Outcome results
None listed