NCT07079579

Enarodustat Tablets at Different Initial Doses for Anemia in Non-dialysis CKD Patients

A Prospective, Single-arm, Open-label Study to Evaluate Different Initial Doses of Enarodustat Tablets for the Treatment of Anemia in Patients With Non-dialysis Chronic Kidney Disease

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the rationality of different initial doses of enarodustat for the treatment of anemia in ND-CKD patients

Detailed description

The eligible subjects screened will be stratified by treatment history and randomized to the 2, 3, 4 mg dose groups in a 1:1:1 ratio. After receiving the initial doses of 2, 3, 4 mg/day for 4 weeks, the subjects will enter a 12-week maintenance treatment period with a total of 7 scheduled visits.

Conditions

• Renal Anemia in Non-dialysis Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Enarodustat 2mg	initial phase：2mg QD for 4 weeks subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks
DRUG	Enarodustat 3mg	initial phase：3mg QD for 4 weeks subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks
DRUG	Enarodustat 4mg	initial phase：4mg QD for 4 weeks subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2025-07-23
• Last updated: 2025-07-23

Locations

1 site across 1 country: China