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This study is to evaluate the efficacy and safety of QLG1218(daprodustat) following a switch from erythropoiesis-stimulating agent (ESA) in Chinese HD subjects with renal anemia who are currently treated with ESA. The primary objective is to demonstrate non-inferiority of QLG1218 to darbepoetin alfa. This study is a randomized, open Label, active-controlled, parallel-group, multi-center Study. The total duration of the study will be approximately 32 weeks including screening and follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daprodustat | Experimental |
| |
| Darbepoetin alfa | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daprodustat | Drug | Subjects will receive oral daprodustat once daily for 28 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Hemoglobin (Hgb) During the Efficacy Evaluation Period | The mean hemoglobin during the Evaluation Period was estimated by a statistical model. | Weeks 25 to 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuai He, Project Manager | Contact | 0531-55820453 | shuai1.he@qilu-pharma.com |
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| Darbepoetin alfa |
| Drug |
Subjects will receive IV darbepoetin alfa once weekly for 28 weeks |
|
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000599718 | GSK1278863 |
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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