Anemia, Chronic Renal Failure
Conditions
Brief summary
The purpose of this study is to evaluate the safety,efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple intravenous doses of EPO-018B in participants with chronic kidney disease (CKD) who are on hemodialysis.
Interventions
DRUGEPO-018B
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females\>=18 and≤65. 2. Receiving dialysis for at least 2 weeks before the first study dose. 3. Patients who have not received any erythropoietic agents within 6 weeks prior to the first study dose. 4. Two hemoglobin values of ≥ 6.0 and \< 10.0 g/dL at Screening 5. Patients with a transferrin saturation ≥ 20% or a ferritin≥ 100 ng/mL. vitamin B12 and folic acid level above lower limit of normal. 6. Signed informed consent.
Exclusion criteria
1. Pregnant or lactating females. 2. Red blood cell transfusion within 3 months prior to study drug administration. 3. Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule or to all parenteral iron supplementation products. 4. Hemolytic syndromes or coagulation disorder. 5. Hematological disease (including but not limited to myelodysplastic syndrome, hematological malignancy, , hemoglobinopathy, pure red cell aplasia). 6. Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis,systemic lupus erythematosus, etc.). 7. C reactive Protein (CRP) level greater than 30 mg/L within the 4 weeks prior to study drug administration. 8. Uncontrolled or symptomatic secondary hyperparathyroidism，iPTH\>500pg/ml. 9. Poorly controlled hypertension within 2 weeks prior to study drug administration, per investigator's clinical judgment (e.g. systolic ≥ 160mm Hg, diastolic ≥ 100 mm Hg). 10. Chronic congestive heart failure (New York Heart Association Class IV). 11. Significant symptom within 6 months prior to study drug administration (e.g. myocardial infarction, serious or precarious coronary artery disease,stroke, respiratory disease, autoimmune disease, neuropathy, phrenopathy, hepatopathy including Active hepatitis B, Active hepatitis C, or ALT\> 2 x upper limit of normal (ULN), AsT\> 2 x upper limit of normal (ULN) , etc.). 12. A positive test for HIV antibody. 13. Tumor malignancy 14. Expected survival less than 12 months, 15. A scheduled kidney transplant 16. Major surgery (may Massive bleeding) during the study 17. Expected conception within 4 Weeks after the end of the Study Treatment 18. The subject has participated in other clinical trial within the 6 weeks prior to study drug administration 19. Have any other condition or prior therapy that, in the investigator's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who achieved a target hemoglobin response during the study | Baseline to Week 24 | A target hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) from baseline and a hemoglobin value ≥ 10.0 g/dL during the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who response to study drug. | Baseline to Week 24 | Hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) from baseline during the study. |
| Average reticulocytes and hemoglobin change from baseline | Baseline to Week 24 | — |
| Incidence of adverse events and serious adverse events | Baseline to Week 24 | — |
Countries
China
Contacts
Primary ContactChanglin Mei
Outcome results
None listed