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This study is a phase 3 randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of SAL-0951 in CKD-anemia patients in Non-dialysis, comprising 8 weeks of double-blind treatment period followed by an open-label treatment period, making up a total of 27 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAL-0951 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAL-0951 | Drug | SAL-0951:
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in mean Hb concentration levels from baseline at weeks 7-9 | Change From Baseline in mean Hb concentration levels at week 7-9 | Baseline and week 7-9 |
| Measure | Description | Time Frame |
|---|---|---|
| double-blind phase:The cumulative percentage of subjects who achieved Hb response at any time from treatment to week 9 | Change From Baseline in cumulative percentage of subjects who achieved Hb response at any time at week 9 | Baseline to week 9 |
| Double-blind phase:Proportion of subjects with average Hb level ≥100 g/L at week 7-9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xueqing Yu, Ph.D | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 519041 | China |
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| Placebo | Drug | SAL-0951 placebo:
|
|
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| Week 7-9 |
| Double-blind phase:Proportion of average Hb concentration ≥100g/L and ≤120g/L in week 9 | Week 9 |
| Double-blind phase:By week 9, the cumulative proportion of subjects whose Hb increased by ≥10 g/L and whose Hb reached ≥100g/L | Week 9 |
| Double-blind phase:By week 9, the cumulative proportion of Hb > 130 g/L | Week 9 |
| Double-blind phase:Proportion of subjects receiving intravenous iron at week 9 | Week 9 |