NCT06720025

Study of SAL-0951 Compared to Recombinant Human Erythropoietin in Anemic Patients Receiving Maintenance Hemodialysis

A Phase 3 Study to Compare the Efficacy and Safety of SAL-0951 With Recombinant Human Erythropoietin Injection in Anemic Patients With Chronic Kidney Disease Receiving Maintenance Hemodialysis <Switch / Maintenance Study>

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of SAL-0951 in Chinese patients undergoing maintenance hemodialysis with chronic kidney disease and anemia，who are receiving stable treatment with erythropoietic stimulants (ESAs).

Detailed description

A randomized, open-label, rHuEPO positive-controlled, parallel-design multicenter clinical trial is used to evaluate the efficacy and safety of SAL-0951 in maintenance hemodialysis patients with anemia in CKD who were stable on ESAs. It is planned to enroll 100 subjects and eligible subjects screened are assigned 1:1 to the test arm and the control arm for a 24-week treatment to verify that the efficacy of SAL-0951 in the treatment of renal anemia in hemodialysis patients is non-inferior to that of rHuEPO and to verify the long-term safety of investigational drug in the treatment of renal anemia by comparing the difference in mean Hb levels between the two arms at weeks 20, 22, and 24 after treatment. The study is mainly divided into four stages: screening period (2 weeks before administration), initial treatment period (4 weeks), maintenance treatment period (20 weeks), and safe follow-up period (2 weeks), requiring a total of 12 visits. This study included the 24th week visit as the end of treatment visit (EOT) and the 26th week as the end of study visit (EOS). Subjects who withdrew early are required to complete the research procedure for week 24.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	SAL-0951 tablets	initial phase：4mg QD subsequent phase：1mg～8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks
DRUG	rHuEPO injection	Initial based on the original rHuEPO dose adjust the dose based on hemoglobin concentration level every 4 weeks

Timeline

• Start date: 2023-09-19
• Primary completion: 2024-06-17
• Completion: 2024-06-20
• First posted: 2024-12-06
• Last updated: 2024-12-06

Locations

1 site across 1 country: China