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This open-labeled, one-center study is designed to evaluate the efficacy and safety of roxadustat in ESA-naïve and ESA-treated pediatric patients with CKD Stages 3, 4, and 5 who are receiving dialysis or not. The study will enroll patients between the ages of 2 to <18 years. Approximately 30 patients will be enrolled.
This study is to evaluate the use of roxadustat for renal anemia in pediatric patients with CKD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roxadustat | Other | Starting doses of 20, 50, 70 or 100 mg/30,70,90,or 120mg based on weight and dialysis or not. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roxadustat | Drug | Starting doses of 20, 50, 70 or 100 mg/30,70,90,or 120mg based on weight and dialysis or not. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with mean Hb ≥ 11.0 g/dL | After the use of roxadustat, the proportion of patients with mean Hb ≥ 11.0 g/dL | weeks 16-24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Hb | weeks 16-24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jianhua Mao, MD | Contact | 086-571-86670015 | maojh88@zju.edu.cn | |
| fei Liu | Contact | alexdevin@163.com |
| Name | Affiliation | Role |
|---|---|---|
| jianhua Map, MD | The Children's Hospital of Zhejiang University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| C584543 | roxadustat |
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