NCT06016036

SAL-0951 Tablets in the Treatment of Renal Anemia in Non-dialysis Chronic Kidney Disease

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Anemia in Non-dialysis Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	SAL-0951	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
DRUG	Placebo	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

Timeline

• Start date: 2020-12-08
• Primary completion: 2021-10-08
• Completion: 2022-02-21
• First posted: 2023-08-29
• Last updated: 2024-08-13

Locations

1 site across 1 country: China