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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegolsihematide | Experimental | Participants received Pegolsihematide by intravenous injection once every 4 weeks ; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL). |
|
| Epoetin Alfa | Active Comparator | Epoetin Alfa administration 1 to 3 times per week. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegol-Sihematide | Drug |
| ||
| Epoetin Alfa |
| Measure | Description | Time Frame |
|---|---|---|
| Average reticulocytes and hemoglobin change from baseline | Baseline to Week 16 |
| Measure | Description | 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 | |
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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 |
|---|---|---|
| Changli 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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| ID | Term |
|---|---|
| D000068817 | Epoetin Alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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|
| 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 |
| 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 |
| D002241 |
| Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |