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To evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kiklin group | Oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bixalomer | Drug | Oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by the incidence of adverse events (including adverse drug reactions), vital signs and laboratory tests | Baseline and 1, 2, 3, 6, 12 months after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Serum phosphorous levels | Baseline and 1, 2, 3, 6, 12 months after administration | |
| Serum albumin level | Baseline and 1, 2, 3, 6, 12 months after administration | |
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Inclusion Criteria:
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Patients with Chronic renal failure with Hyperphosphatemia receiving Peritoneal dialysis
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chugoku | Japan | |||||
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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| Serum calcium level |
| Baseline and 1, 2, 3, 6, 12 months after administration |
| Serum intact PTH (parathyroid hormone) level | Baseline and 1, 2, 3, 6, 12 months after administration |
| Chūbu |
| Japan |
| Hokkaido | Japan |
| Kansai | Japan |
| Kanto | Japan |
| Kyushu | Japan |
| Shikoku | Japan |
| Tōhoku | 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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| ID | Term |
|---|---|
| C000589735 | bixalomer |
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