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The goal of this clinical trial is to learn about the following questions in the patients receiving maintenance hemodialysis with elevated blood phosphorus:
Participants will receive either following treatments:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AP-306 | Experimental |
| |
| Sevelamer Carbonate | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AP-306 | Drug | A blood phosphorus lowering drug with a novel mechanism |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of AP-306 assessed by serum phosphorus lowering | The change in serum phosphorus level from the baseline to the end of treatment | 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the overall safety of AP-306 assessed by incidence of treatment-emergent adverse events | All adverse events occurred after the study treatment initiation will be collected and their nature, frequency, and severity will be assessed. | 15 weeks |
Important Inclusion Criteria:
Important Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Wang, MD | Sichuan Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | 610072 | China |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Sevelamer Carbonate |
| Drug |
A phosphate binder |
|
| 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 |
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |