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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
156
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
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
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.