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| Name | Class |
|---|---|
| Akebia Therapeutics | INDUSTRY |
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This trial is an investigator-initiated, multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the safety of vadadustat administered three times per week for the treatment of anemia in in-center hemodialysis patients with End Stage Kidney Disease (ESKD). This study will obtain long-term safety data in a large sample of subjects receiving in-center hemodialysis to support adoption of three times per week vadadustat dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vadadustat | Experimental | Vadadustat, 300 mg tablets, administered orally three times per week |
|
| Erythropoiesis-stimulating agent (ESA) - Standard of Care (SOC) | Active Comparator | Epoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp) administered as per standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vadadustat | Drug | A synthetic, orally bioavailable, small molecule being developed as an inhibitor of hypoxia-inducible factor prolyl-hydroxylases for the treatment of anemia associated with chronic kidney disease. Intervention to be administered to maintain hemoglobin within a target range of 10-11 g/dL. |
| Measure | Description | Time Frame |
|---|---|---|
| Combination of the hierarchical endpoints of all-cause mortality and all-cause hospitalization. | The hierarchical endpoints of all-cause mortality and all cause hospitalization will be analyzed by the win odds method with ranking all cause mortality more important than all cause hospitalization. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause hospitalization | All-cause hospitalization | 18 months |
| All-cause mortality | All-cause mortality | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USRC Kidney Research | Lone Tree | Colorado | 80124 | United States | ||
| Nephrology and Hypertension Specialists, PC |
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| ID | Term |
|---|---|
| C000624313 | vadadustat |
| D006397 | Hematinics |
| D000068817 | Epoetin Alfa |
| C508420 | continuous erythropoietin receptor activator |
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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|
|
| Erythropoiesis Stimulating Agent | Drug | Standard of care erythropoiesis stimulating agent will be administered to maintain hemoglobin within a target range of 10-11 g/dL. |
|
|
| Dalton |
| Georgia |
| 30720 |
| United States |
| US Renal Care - Gallup | Gallup | New Mexico | 87301 | United States |
| Dallas Renal Group | Dallas | Texas | 75230 | United States |
| US Renal Care - Live Oak | Live Oak | Texas | 78233 | United States |
| D004921 |
| Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| 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 |