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The purpose of this study is to evaluate the safety and efficacy of Nephoxil capsule administration for the improvement of hyperphosphatemia in CKD patients undergoing hemodialysis under actual conditions of routine medical care.
This study is a prospective observational study, and only observable information is collected during Visits 1 to 13 of the subjects' routine outpatient visits. Therefore, no further visits related to this study are planned, and all treatments, examinations, and evaluations necessary for the subjects shall be conducted at the discretion of the investigator.
The initial dose of Nephoxil capsules for the subjects participating in this study shall be determined at the investigator's discretion, and subjects shall be classified into either the low-dose group (1.5 g/day) or the standard-dose group (4 g/day) according to the initial dose. During the observation period, dose titration within 1 g may be performed at the investigator's discretion, and in such cases, the maximum dose per day shall not exceed 6 g.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low-dose group | initial dose 1.5 g/day |
| |
| standard-dose group | initial dose 4 g/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the low-dose group (1.5 g/day) or the standard-dose group (4 g/day) | Drug | The initial dose of Nephoxil capsules for the subjects participating in this study shall be determined at the investigator's discretion, and subjects shall be classified into either the low-dose group (1.5 g/day) or the standard-dose group (4 g/day) according to the initial dose. It will be conducted with 13 visits over 48 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48 | Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48 | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of subjects whose average serum phosphorus levels at Weeks 40, 44, and 48 reached the target serum phosphorus level (3.5 - 5.5 mg/dL) | Ratio of subjects whose average serum phosphorus levels at Weeks 40, 44, and 48 reached the target serum phosphorus level (3.5 - 5.5 mg/dL) | 40 ~ 48 weeks |
| Mean change from baseline to week 48 in serum phosphorus level |
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Inclusion Criteria:
Exclusion Criteria:
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Hyperphosphatemia in patients with CKD undergoing hemodialysis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hyeokjun choi | Contact | 01074713471 | hyeokjun.choi.2j@kyowakirin.com |
| Name | Affiliation | Role |
|---|---|---|
| hyeokjun choi | Kyowa Kirin Korea Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jesus Hospital | Recruiting | Jeonju | South Korea |
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| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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Mean change from baseline to week 48 in serum phosphorus level |
| 48 weeks |
| Initial dose retention period | Initial dose retention period | Up to 48weeks |