Renal anemia
Conditions
Interventions
Treatment group:rhEPO 12000IU, once a week, was administered by i.v. injection, for 24 weeks
Control group:rhEPO 4000IU, three times a week, was administered by i.v. injection, for 24 weeks
Sponsors
Beijing Friendship Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Hb concentration should be 100 to 120 g/L; 2. Patient aged 18 to 75 years old; 3. Treatment of rhEPO stable for 3 months; 4. Regular hemodialysis for more than 3 months, the condition stabilizers (full dialysis Kt/V = 1.2); 5. During the first four weeks of the test, the serum iron protein > 200ng/ml, transfer-iron protein saturation > 20%; 6. Those who have signed informed consent forms have been subject to voluntary trial.
Exclusion criteria
Exclusion criteria: 1. with uncontrolled severe hypertension (SP = 180mmHg, DP = 110, mmHg); 2. patients with congestive heart failure [New York Heart Association cardiac function class III or higher]; 3. AST or ALT value > 2 high limitation of normal value and Alb 15mg/L was in the first 4 weeks; 5. the examination of fecal occult blood positive was in the first 4 weeks; 6. patients who had undergone surgery with massive bleeding or who were scheduled to undergo surgery during the clinical trial (except for arteriovenous shunt surgery) in recent three months; 7. complicated with malignant tumors (including hematological malignancies), hematological diseases (myelodysplastic syndromes, hemolytic anemia, etc.) or obvious hemorrhagic diseases; 8. receiving anabolic steroids, testosterone or androgenic medication in recent three months; 9. previous functional organ transplantation or scheduled organ transplantation or without kidney disease; 10. previous alcoholic and drug abusers; 11. patients with neurological and psychiatric disorders who cannot cooperate or are unwilling to cooperate; 12. allergic or allergic or ESAs resistant to known components of test or control drugs; 13. pregnant women, lactating women or recent fertility planners; 14. history of blood transfusion within 3 months; 15. participated in other clinical trials in the past 3 months; 16. the researchers believe that there is any other medical condition that is not suitable for the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the hemoglobin value; | — |
Secondary
| Measure | Time frame |
|---|---|
| RC Hct Hemoglobin variability rhEPO of average weekly dose, injection frequency and total number of injections and total dose comparison; | — |
Contacts
Public ContactLiu Wenhu
Beijing Friendship Hospital Capital Medical University
Outcome results
None listed