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The objective of this study is to assess the long-term safety and efficacy of bixalomer under post-marketed setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic kidney disease | Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bixalomer | Drug | Oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the serum concentrations of phosphate | Baseline and up to Month 12 | |
| Change from baseline in the corrected serum concentrations of calcium | Baseline and up to Month 12 | |
| Change from baseline in the serum concentrations of intact parathyroid hormone | Baseline and up to Month 12 | |
| Safety assessed by incidence of adverse events | Up to Month 12 |
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Inclusion Criteria:
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Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site JP00006 | Aichi | Japan | ||||
| Site JP00010 |
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C000589735 | bixalomer |
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| Ehime |
| Japan |
| Site JP00012 | Fukuoka | Japan |
| Site JP00004 | Gifu | Japan |
| Site JP00001 | Ibaraki | Japan |
| Site JP00009 | Kagawa | Japan |
| Site JP00003 | Kanagawa | Japan |
| Site JP00011 | Kochi | Japan |
| Site JP00014 | Kumamoto | Japan |
| Site JP00013 | Nagasaki | Japan |
| Site JP00007 | Osaka | Japan |
| Site JP00005 | Shizuoka | Japan |
| Site JP00002 | Tochigi | Japan |
| Site JP00008 | Wakayama | Japan |
| 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 |