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

NCT07359027 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2026-01-26

No results posted yet for this study

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).

Conditions

  • Diabetic Kidney Disease
  • Anemia

Interventions

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).

Sponsors & Collaborators

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • The Third Xiangya Hospital of Central South University

    collaborator OTHER

  • Second Xiangya Hospital of Central South University

    lead OTHER

Principal Investigators

  • Lin Sun, doctor · Department of Nephrology, Second Xiangya hospital of central south university, Changsha, China.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2022-12-31
Completion
2024-07-08

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07359027 on ClinicalTrials.gov