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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPO-018B 0.025 mg/kg | Experimental | 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 |
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| EPO-018B 0.05 mg/kg | Experimental | 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 |
|
| EPO-018B 0.08 mg/kg | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPO-018B | Drug |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changlin Mei | Contact | 021-81886191 | Chlmei1954@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Changlin Mei | Changzheng Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changzheng Hospital | Recruiting | Shanghai | Shanghai Municipality | 200003 | China |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Baseline to Week 24 |
| Incidence of adverse events and serious adverse events | Baseline to Week 24 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |