Anemia, Chronic Renal Failure, Dialysis
Conditions
Keywords
ESAs CKD
Brief summary
The purpose of this study is to evaluate the safety and efficacy of multiple intravenous doses of pegol-Sihematide in participants with chronic kidney disease (CKD) who are on dialysis.
Interventions
DRUGpegol-Sihematide
DRUGEpoetin Alfa
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females≥18 and≤70, Weight ≥ 45 kilograms (kg) 2. Participants with chronic renal failure on dialysis for ≥ 3 months prior to randomization. 3. On ESAs treatment for ≥8 weeks prior to randomization with stable doses and the average doses ≤ 10000 IU/week 4. Hemoglobin values of ≥ 10.0 and≤ 12.0 g/dL at Screening 5. Patients with a transferrin saturation≥ 20% and 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 randomization 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) greater than 30 mg/L within the 4 weeks prior to randomization 8. Uncontrolled or symptomatic secondary hyperparathyroidism(iPTH\>800pg/ml) 9. Poorly controlled hypertension within 4 weeks prior to randomization 10. Chronic congestive heart failure (New York Heart Association Class Ⅲ or IV) 11. significant symptom within 6 months prior to randomization (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, A positive test for HIV antibody or ALT\> 2 x upper limit of normal (ULN), AST\> 2 x upper limit of normal (ULN)) 12. tumor malignancy 13. Expected survival less than 12 months 14. A scheduled kidney transplant 15. Major surgery (may Massive bleeding) during the study 16. expected conception within 4 Weeks after the end of the Study Treatment 17. The subject has participated in other clinical trial within the 12 weeks prior to randomization 18. 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 |
|---|---|
| Average reticulocytes and hemoglobin change from baseline | Baseline to Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients whose Hb within ±1.0 g/dL of baseline during Weeks 12 to 16 | week 12 to 16 |
| Average RBC, hematokrit and reticulocytes change from baseline | Baseline to Week 16 |
| Proportion of patients whose Hb levels were maintained within 10 to 12.0g/dL during Weeks 12 to 16 | week 12 to 16 |
| Incidence of adverse events and serious adverse events | Baseline to Week 16 |
Countries
China
Contacts
Primary ContactChanglin Mei
Outcome results
None listed