A Phase 2, Open-Label, Multi-Center , Dose-Finding Study of the Safety and Efficacy of Pegol-Sihematide (EPO-018B) for the Treatment of Anemia in Patients With End-Stage Renal Disease Receiving Maintenance Hemodialysis (HD)
Overview
- Phase
- Phase 2
- Intervention
- EPO-018B
- Conditions
- Chronic Renal Failure
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Percentage of participants who achieved a target hemoglobin response during the study
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males or females\>=18 and≤
- •Receiving dialysis for at least 2 weeks before the first study dose.
- •Patients who have not received any erythropoietic agents within 6 weeks prior to the first study dose.
- •Two hemoglobin values of ≥ 6.0 and \< 10.0 g/dL at Screening
- •Patients with a transferrin saturation ≥ 20% or a ferritin≥ 100 ng/mL. vitamin B12 and folic acid level above lower limit of normal.
- •Signed informed consent.
Exclusion Criteria
- •Pregnant or lactating females.
- •Red blood cell transfusion within 3 months prior to study drug administration.
- •Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule or to all parenteral iron supplementation products.
- •Hemolytic syndromes or coagulation disorder.
- •Hematological disease (including but not limited to myelodysplastic syndrome, hematological malignancy, , hemoglobinopathy, pure red cell aplasia).
- •Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis,systemic lupus erythematosus, etc.).
- •C reactive Protein (CRP) level greater than 30 mg/L within the 4 weeks prior to study drug administration.
- •Uncontrolled or symptomatic secondary hyperparathyroidism，iPTH\>500pg/ml.
- •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).
- •Chronic congestive heart failure (New York Heart Association Class IV).
Arms & Interventions
EPO-018B 0.025 mg/kg
EPO-018B starting dose of 0.025 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 6 doses
Intervention: EPO-018B
EPO-018B 0.05 mg/kg
EPO-018B starting dose of 0.05 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 6 doses
Intervention: EPO-018B
EPO-018B 0.08 mg/kg
EPO-018B starting dose of 0.08 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 6 doses
Intervention: EPO-018B
Outcomes
Primary Outcomes
Percentage of participants who achieved a target hemoglobin response during the study
Time Frame: 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 Outcomes
- Incidence of adverse events and serious adverse events(Baseline to Week 24)
- Average reticulocytes and hemoglobin change from baseline(Baseline to Week 24)
- Percentage of participants who response to study drug.(Baseline to Week 24)