NCT06720233

Efficacy and Safety Study of SAL-0951 in the Treatment of Renal Anemia in Patients Receiving Peritoneal Dialysis

A Phase III, Multicenter, Open-label, Single-arm Clinical Study to Evaluate the Efficacy and Safety of SAL-0951 Tablets in the Treatment of Renal Anemia in Patients With Chronic Kidney Disease Receiving Maintenance Peritoneal Dialysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 37 (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 receiving peritoneal dialysis with chronic kidney disease and anemia

Detailed description

This is a multicenter, open-label, single-arm clinical study (using individualized dose adjustment design). Eligible subjects after screening will be assigned to the test group for a 24-week treatment to verify the efficacy and safety of SAL-0951 in the treatment of renal anemia in patients receiving peritoneal dialysis. The study is mainly divided into four stages: screening period (2 or 4 weeks before administration), initial treatment period (4 weeks), maintenance treatment period (20 weeks), and safety follow-up period (2 weeks), requiring a total of 11 visits. This study includes the 24th week visit as the end of treatment visit (EOT) and the 26th week as the end of study visit (EOS). Subjects who withdraw early will be 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

Timeline

• Start date: 2002-02-22
• Primary completion: 2024-10-18
• Completion: 2024-10-28
• First posted: 2024-12-06
• Last updated: 2024-12-06

Locations

1 site across 1 country: China