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The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of sequential ascending doses of JTZ-951 administered for 15 days in anemic subjects with end-stage renal disease (ESRD) receiving hemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 JTZ-951 or Placebo | Experimental | Tablets, 1 dose per day for 15 days |
|
| Dose 2 JTZ-951 or Placebo | Experimental | Tablets, 1 dose per day for 15 days |
|
| Dose 3 JTZ-951 or Placebo | Experimental | Tablets, 1 dose per day for 15 days |
|
| Dose 4 JTZ-951 or Placebo | Experimental | Tablets, 1 dose per day for 15 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JTZ-951 | Drug | Subjects will receive JTZ-951 or Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | 15 days | |
| Vital signs and 12 lead ECGs | 15 days | |
| Cmax (maximum concentration) | 15 days | |
| tmax (time to reach maximum concentration) | 15 days | |
| t1/2 (elimination half-life) | 15 days | |
| AUC (area under the concentration-time curve) | 15 days | |
| AR (accumulation ratio) | 15 days | |
| RBC (red blood cell) count | 15 days | |
| Hgb (hemoglobin) | 15 days | |
| TSAT (transferrin saturation) | 15 days | |
| serum ferritin | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hideyuki Yamamoto | Akros Pharma Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lakewood | Colorado | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36005278 | Derived | Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2. |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| C000656654 | enarodustat |
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| Placebo | Drug |
|
| Miami |
| Florida |
| United States |
| Orlando | Florida | United States |
| Minneapolis | Minnesota | United States |
| Saint Paul | Minnesota | United States |
| D014570 |
| Urologic Diseases |
| 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 |