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This is a randomized, double blind, placebo-controlled multi-center study to examine the efficacy and safety of ASP1585 in chronic kidney disease patients with hyperphosphatemia not on dialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP1585 group | Experimental |
| |
| placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP1585 | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in serum phosphorus level at the end of treatment | Baseline and Week 12 or treatment discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement rate of the target range of serum phosphorus level | During 12 week treatment | |
| Time to achieve the target range of serum phosphorus level | During 12 week treatment | |
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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 |
|---|---|---|---|
| 40576086 | Derived | Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000589735 | bixalomer |
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| placebo | Drug | oral |
|
| Time-course changes in serum phosphorus levels |
| During 12 week treatment |
| Time-course changes in serum calcium levels | During 12 week treatment |
| Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs | During 12 week treatment |
| Hokkaido |
| Japan |
| Kansai | Japan |
| Kanto | Japan |
| Kyushu | Japan |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |