Chronic kidney disease with anemia
Conditions
Interventions
0.5ug/Kg subcutaneous infusion group:The dosage is 0.5 ug/Kg, subcutaneous injection, once a week, for 4 weeks
1.0µg/Kg subcutaneous infusion group:The dosage is 1.0 ug/Kg, subcutaneous injection, once a week, for 4 weeks
2.0ug/Kg subcutaneous infusion group:The dosage is 2.0 ug/Kg, subcutaneous injection, once a week, for 4 weeks
0.5ug/Kg intravenous infusion group:The dosage is 0.5 ug/Kg, intravenous injection, once a week, for 4 weeks
Sponsors
Shengjing Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75; 2. chronic kidney disease (CKD) diagnosed by investigators according to the National Kidney Foundation (NKF) formulated Kidney Disease Outcomes Quality Initiative ( K/DOQI ) guidelines: (1) Kidney injury (abnormal of renal structural or functional) >=3 months, with or without reduced glomerular filtration rate, clinical manifestations pathology abnormal or renal injury (including blood, urine composition abnormalities or imaging abnormalities); (2) eGFR =3 months, with or without evidence of renal injury; 5. Dialysis or non dialysis patients whose emoglobin concentration between (including) 6-10g/dL. Patients undergoing hemodialysis receive continuous dialysis for more than 1 months, in stable condition; 6. Serum ferritin >10ng/ml or transferrin saturation >20%; 7. Be able to understand and comply with the protocol requirements, can be expected to complete the entire study process; 8. Voluntarily signed on informed consent.
Exclusion criteria
Exclusion criteria: 1) History of anaphylaxis or allergy to biological drug; 2) Subjects who are pregnant or nursing a child; 3) Female subjects only take oral contraceptive, and are planning pregnancy during the study or within 3 months post administration; 4) Male subjects, whose female partner is planning pregnancy during the study or within 3 months post administration; 5) Female subjects receiving estrogen therapy after menopause; 6) Subjects with malignant hypertension or poor hypertension control( systolic blood pressure > 160 mmHg or diastolic blood pressure > 100mmHg ), or having a history of thromboembolic disease or hematopoietic system disease; 7) Reticulocyte>=3%; 8) serum ferritin <10ng/ml and Transferrin saturation <20%; 9) Donated blood or received a blood transfusion treatment within 90 days of inclusion; 10) Participated in other drug study within 4 weeks of inclusion; 11) Subjects who have received recombinant erythropoiesis stimulating protein or rHuEPO treatment within 3 months of inclusion; 12) Patients with EPO resistance; EPO resistance is the situation that subcutaneous infusion of rHuEPo reached 300IU/(kg.wk)(total 20000IU.wk) or intravenous infusion of rHuEPO 500IU/(kg.wk)(total 30000Iu/week) for 4 months after the treatment, Hb still fails to achieve or maintain the target value; 13) Patients with recombinant erythropoiesis stimulating protein (RESP) antibody or endogenous erythropoietin (EPO) antibody; 14) Subjects who have taken organs damage drug known by now within 3 months of inclusion; 15) Patients with malignant tumors (excluding non-melanoma skin cancer or in situ excision cancer); 16) Patients with severe cardiovascular and cerebrovascular diseases, or heart failure (NYHA grade III or IV); 17) Patients with hypercoagulable tendency; 18) Abnormal liver function (aminotransferase greater than 2 times of the upper limit of normal value); 19) Patients with active infection; 20) Patients undergoing immunosuppressive therapy, unless have reached a stable dose level; 21) Subjects with alcohol abuse, drug abuse or drug addiction; 22) Subjects who in the opinion of the investigator are unsuitable for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical Examination;Routine hematology;Biochemistry;Urinalysis;Serum ferritin;Chest X-ray detection;Recombinant erythropoiesis stimulating protein antibody;Endogenous erythropoietin antibody detection;Reticulocyte count;Coagulation test; | — |
Countries
China
Contacts
Public ContactLi Detian
Shengjing Hospital of China Medical University
Outcome results
None listed