Safety & Efficacy of EPO-018B for the Treatment of Anemia in Participants With ERSD Receiving Maintenance Hemodialysis

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Chronic Renal Failure, Anemia

Intervention / Treatment
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* Drug: EPO-018B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females>=18 and≤65. 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). 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.). A positive test for HIV antibody. Tumor malignancy Expected survival less than 12 months, A scheduled kidney transplant Major surgery (may Massive bleeding) during the study Expected conception within 4 Weeks after the end of the Study Treatment The subject has participated in other clinical trial within the 6 weeks prior to study drug administration 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EPO-018B 0.025 mg/kg<br>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 | Drug: EPO-018B<br> <br> |
| Experimental: EPO-018B 0.05 mg/kg<br>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 | Drug: EPO-018B<br> <br> |
| Experimental: EPO-018B 0.08 mg/kg<br>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 | Drug: EPO-018B<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who achieved a target hemoglobin response during the study | 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 | Baseline to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who response to study drug. | Hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) from baseline during the study. | Baseline to Week 24 | 
| Average reticulocytes and hemoglobin change from baseline |  | Baseline to Week 24 | 
| Incidence of adverse events and serious adverse events |  | Baseline to Week 24 |