NCT07359027

Study of Roxadustat's Effect on Anemia in Patients With Diabetic Kidney Disease

Clinical Observation of Roxadustat's Effect on Anemia in Patients With Diabetic Kidney Disease (Stage III-IV)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Second Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open-label, multicenter and prospective study, which is conducted to evaluate the effect of Roxadustat on anemia in subjects with DKD (stage III-IV).

Detailed description

This study will consist of three study periods as follows: Screening Period: 2 weeks Treatment Period: 24weeks Follow-up Period: 4 weeks

Conditions

• Diabetic Kidney Disease
• Anemia

Interventions

Type	Name	Description
DRUG	Roxadustat	The starting dose of Roxadustat will be defined as per the China Package Insert. The recommended starting dose of roxadustat will depend on the body weight of the patient (based on patient's empty weight prior to instillation of dialysate): 70 mg (40 to \< 60 kg) tiw or 100 mg (≥ 60 kg) tiw. The frequency of hemoglobin concentration test should be ≥ once every 4 weeks. The dose will be adjusted according to the following table every 4 weeks to achieve and/or maintain hemoglobin within the target range (10.0-12.0 g/dl).

Timeline

• Start date: 2021-11-02
• Primary completion: 2022-12-31
• Completion: 2024-07-08
• First posted: 2026-01-22
• Last updated: 2026-01-26

Locations

1 site across 1 country: China