A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study of SAL-0951 Tablets in the Treatment of Renal Anemia in Non-dialysis Chronic Kidney Disease

Shenzhen Salubris Pharmaceuticals Co., Ltd.1 site in 1 country156 target enrollmentDecember 8, 2020

ConditionsRenal Anemia in Non-dialysis Chronic Kidney Disease

InterventionsSAL-0951 Placebo

Overview

Phase: Phase 3
Intervention: SAL-0951
Conditions: Renal Anemia in Non-dialysis Chronic Kidney Disease
Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.
Enrollment: 156
Locations: 1
Primary Endpoint: Difference in mean Hb concentration levels from baseline at weeks 7-9
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 8, 2020

End Date

February 21, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shenzhen Salubris Pharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged 18-75 years old men and women;
•40-100 kg weight;
•The glomerular filtration rate value calculated by CKD-EPI formula is \<60 mL/min/1.73 m\^2 (stage 3, 4 or 5 of KDOQI chronic kidney disease) in non-dialyzed subjects with confirmed anemia of chronic kidney disease;
•Ferritin \> 100 g/L and TSAT \> 20%;
•No treatment with ESA was received at least 8 weeks before randomization, and the central laboratory hemoglobin value for the last two screening period (at least 6 days interval) \>=80 g/L and \<=105 g/L, and the change of absolute value of the two visits \<=10g/L;
•The investigators determined that dialysis or alternative kidney transplantation was not required throughout the trial;
•Volunteer to participate in the trial and have an informed consent form signed.

Exclusion Criteria

•Blood pressure control was poor after regular drug therapy for more than 4 weeks before screening, SBP \> 160mmHg or DBP \> 100mmHg during screening;
•Patients with severe complications of hepatobiliary system (AST or ALT \> 2.5 ULN, TBiL \> 1.5 ULN);
•Acute kidney injury occurred 12 weeks before screening;
•NYHA class III - IV heart failure or unstable angina;
•Acute myocardial infarction, transient ischemic attack, cerebral infarction or pulmonary embolism, deep venous thrombosis occurred 6 months before randomization;
•Patients requiring ophthalmologic treatment for diabetic eye disease, diabetic macular edema, or age-related macular degeneration, or patients with hypertrophic choroid or retinopathy;
•Blood transfusion or red blood cell infusion within 3 months before screening;
•Subjects received protein anabolic hormone, testosterone heptanoate, or methadone within 3 month before screening
•Severe hyperparathyroidism (iPTH\>=500pg/mL);
•Patients with HIV, HCV or Treponema pallidum antibody positive, or HBsAg positive with HBV DNA\>=1000 U/mL;

Arms & Interventions

SAL-0951

Intervention: SAL-0951

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Difference in mean Hb concentration levels from baseline at weeks 7-9

Time Frame: Baseline and week 7-9

Change From Baseline in mean Hb concentration levels at week 7-9

Secondary Outcomes

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：The cumulative percentage of subjects who achieved Hb response at any time from treatment to week 9(Baseline to week 9)
Double-blind phase：Proportion of subjects with average Hb level ≥100 g/L at week 7-9(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 Hb > 130 g/L(Week 9)
Double-blind phase：Proportion of subjects receiving intravenous iron at week 9(Week 9)