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To evaluate the superiority to placebo, dose-responsibility and safety.
This is a multi-center, randomized, double blind placebo-controlled and open label sevelamer hydrochloride-controlled, dose-ranging study in CKD patients with hyperphosphatemia on hemodialysis. Patients will be randomly allocated to one of the five treatment groups (ASP1585: 3 dose, placebo, Sevelamer hydrochloride) and advance to the 4-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP1585 dose #1 | Experimental |
| |
| ASP1585 dose #2 | Experimental |
| |
| ASP1585 dose #3 | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Sevelamer hydrochloride | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP1585 | Drug | Oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum phosphorus | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum phosphorus level by time | Up to 4 weeks | |
| Percent of patients meeting the target range of serum phosphorus (3.5-6.0 mg/dL) and achieving time | 4 Weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chugoku | 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. | |
| 24975892 | Derived | Akizawa T, Origasa H, Kameoka C, Kaneko Y, Kanoh H. Dose-finding study of bixalomer in patients with chronic kidney disease on hemodialysis with hyperphosphatemia: a double-blind, randomized, placebo-controlled and sevelamer hydrochloride-controlled open-label, parallel group study. Ther Apher Dial. 2014 Jun;18 Suppl 2:24-32. doi: 10.1111/1744-9987.12202. |
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| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051437 | Renal Insufficiency |
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| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
Oral |
|
| Sevelamer hydrochloride | Drug | Oral |
|
| Change in corrected serum Ca level |
| 4 weeks |
| Change in Ca×P | 4 weeks |
| Change in intact PTH | 4 weeks |
| Chūbu |
| Japan |
| Kansai | Japan |
| Kanto | Japan |
| Kyushu | Japan |
| Shikoku | Japan |
| 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 |