Chronic kidney disease with Anaemia
Conditions
Interventions
2.50µg/Kg subcutaneous infusion group:Single dose of study drug through subcutaneous infusion: 2.50µg/Kg
3.00µg/Kg subcutaneous infusion group:Single dose of study drug through subcutaneous infusion: 3.00µg/Kg
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18-65 years; 2) chronic kidney disease (CKD) diagnosed by investigators according to the National Kidney Foundation (NKF) formulated Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines; 3) Dialysis or non dialysis patients whose emoglobin concentration below the lower limit of the normal value (male Hgb10ng/ml or transferrin saturation >=20%; 5) Be able to understand and comply with the protocol requirements, can be expected to complete the entire study process; 6) Voluntarily signed on informed consent form.
Exclusion criteria
Exclusion criteria: 1) History of anaphylaxis or allergy to biological drug; 2) Subjects who are pregnant or nursing a child; Female subjects receiving estrogen therapy after menopause; 3) Female subjects only take oral contraceptive, and are planning pregnancy during the study or within 3 months post administration; Male subjects, whose female partner is planning pregnancy during the study or within 3 months post administration; 4) Subjects with malignant hypertension or poor hypertension control(systolic pressure >160 mmHg or diastolic pressure >100mmHg), or having a history of thromboembolic disease ,or hematopoietic system disease, or with hypercoagulable tendency; 5) Patients with malignant tumors (excluding non-melanoma skin cancer or in situ excision cancer) or severe cardiovascular and cerebrovascular diseases, or heart failure (NYNA grade III or IV), or active infection; 6) Abnormal liver function (of ALT or AST is greater than 2 times of the upper limit of normal value); 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 90 days of inclusion; 11) Subjects who have received recombinant erythropoiesis stimulating protein or rHuEPO treatment within 30 days of inclusion; 12) Subjects who have taken organs damage drug known by now within 3 months of inclusion; 13) Patients undergoing immunosuppressive therapy, unless have reached a stable dose level; 14) Subjects with alcohol abuse, drug abuse or drug addiction; 15) 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; 16) Patients with recombinant erythropoiesis stimulating protein (RESP) antibody or endogenous erythropoietin (EPO) antibody; 17) 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 detection;Endogenous erythropoietin antibody detection;Reticulocyte count;Coagulation test;Transferrin saturatio; | — |
Countries
China
Contacts
Public ContactMei Changlin
Shanghai Changzheng Hospital
Outcome results
None listed