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This study is to evaluate the safety and the dose-response of ASP1517 in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied intermittently.
To evaluate the safety and the dose-response of ASP1517 on Hemoglobin (Hb) correction in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied intermittently. Patients will receive ASP1517 three times a week (TIW) for first 6weeks. Patients may have the second-randomization to TIW dosing or once-a-week (QW) dosing at Week 6, 8, 10, 12, 14 or 16 if patients meet the criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP1517 low dose group | Experimental | Oral |
|
| ASP1517 middle dose group | Experimental | Oral |
|
| ASP1517 high dose group | Experimental | Oral |
|
| Placebo group | Placebo Comparator | Oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP1517 | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of rise in Hb (g/dL/week) at Week 6 | Baseline and at 6 weeks after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of cumulative number of responder patients | responder is defined as a Hb â¥10.0 g/dL and an increase in Hb by â¥1.0 g/dL | for 28 weeks after dosing |
| Percentage of visits at which patients maintain Hb between 10.0-12.0 g/dL after achieving Hb â¥10.0 g/dL for each patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chūbu | Japan | |||||
| 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. | |
| 30953333 | Derived | Akizawa T, Iwasaki M, Otsuka T, Reusch M, Misumi T. Roxadustat Treatment of Chronic Kidney Disease-Associated Anemia in Japanese Patients Not on Dialysis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial. Adv Ther. 2019 Jun;36(6):1438-1454. doi: 10.1007/s12325-019-00943-4. Epub 2019 Apr 5. |
| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website. | View source |
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Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
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| Placebo | Drug | Oral |
|
| for 28 weeks after dosing |
| Percentage of patients who maintain Hb between 10.0-12.0 g/dL at each visit | Before and Week-2, -3, -4, -6, -8, -10, -12, -14, -16, -18, -20, -22, -24 and -28 |
| Change from baseline in Hb | Before and Week-2, -3, -4, -6, -8, -10, -12, -14, -16, -18, -20, -22, -24 and -28 |
| Safety assessed as the incidence of adverse events, vital signs, 12-lead ECGs and lab-tests | for 28 weeks after dosing |
| Hokkaido |
| Japan |
| Kansai | Japan |
| Kanto | Japan |
| Kyushu | Japan |
| Shikoku | Japan |
| TÅhoku | Japan |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| 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 |
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