A Phase 3 interventional study of SAL-0951 and Placebo in Renal Anemia in Non-dialysis Chronic Kidney Disease, sponsored by Shenzhen Salubris Pharmaceuticals Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by Shenzhen Salubris Pharmaceuticals Co., Ltd. · Phase 3, Interventional, and Treatment
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 156 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Shenzhen Salubris Pharmaceuticals Co., Ltd. is the lead sponsor of 39 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: SAL-0951
Drug: Placebo
SAL-0951: 1. initial phase:4mg QD for 8 weeks 2. subsequent phase:1mg、2mg、4mg、6mg、8mg QD,adjust the dose based on hemoglobin concentration level every 4 weeks
Also known as: SAL-0951 group
SAL-0951 placebo: 1. initial phase:4mg QD for 8 weeks 2. subsequent phase:1mg、2mg、4mg、6mg、8mg QD,adjust the dose based on hemoglobin concentration level every 4 weeks
Also known as: Placebo phase
Difference in mean Hb concentration levels from baseline at weeks 7-9
Change From Baseline in mean Hb concentration levels at week 7-9
Time frame: Baseline and week 7-9
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
Time frame: Baseline to week 9
Double-blind phase:Proportion of subjects with average Hb level ≥100 g/L at week 7-9
Time frame: Week 7-9
Double-blind phase:Proportion of average Hb concentration ≥100g/L and ≤120g/L in week 9
Time frame: 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
Time frame: Week 9
Double-blind phase:By week 9, the cumulative proportion of Hb > 130 g/L
Time frame: Week 9
Double-blind phase:Proportion of subjects receiving intravenous iron at week 9
Time frame: Week 9
Plan to share: No
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Shenzhen Salubris Pharmaceuticals Co., Ltd.