drugset / Trial / NCT07359027
Study of Roxadustat's Effect on Anemia in Patients With Diabetic Kidney Disease
Phase 4
Completed
124 enrolled
Second Xiangya Hospital of Central South University
The Third Xiangya Hospital of Central South University · collabXiangya Hospital of Central South University · collab
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2021-11-02
- Primary completion
- 2022-12-31
- Completion
- 2024-07-08
Publications
- Background Chen N, Hao C, Peng X, Lin H, Yin A, Hao L, Tao Y, Liang X, Liu Z, Xing C, Chen J, Luo L, Zuo L, Liao Y, Liu BC, Leong R, Wang C, Liu C, Neff T, Szczech L, Yu KP. Roxadustat for Anemia in Patients with Kidney Disease Not Receiving Dialysis. N Engl J Med. 2019 Sep 12;381(11):1001-1010. doi: 10.1056/NEJMoa1813599. Epub 2019 Jul 24.
- Background Chen N, Hao C, Liu BC, Lin H, Wang C, Xing C, Liang X, Jiang G, Liu Z, Li X, Zuo L, Luo L, Wang J, Zhao MH, Liu Z, Cai GY, Hao L, Leong R, Wang C, Liu C, Neff T, Szczech L, Yu KP. Roxadustat Treatment for Anemia in Patients Undergoing Long-Term Dialysis. N Engl J Med. 2019 Sep 12;381(11):1011-1022. doi: 10.1056/NEJMoa1901713. Epub 2019 Jul 24.
- Background Yan Z, Xu G. A Novel Choice to Correct Inflammation-Induced Anemia in CKD: Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor Roxadustat. Front Med (Lausanne). 2020 Aug 6;7:393. doi: 10.3389/fmed.2020.00393. eCollection 2020.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Roxadustat | Small molecule | 70 mg | Oral |
| Subject | Roxadustat | Small molecule | 100 mg | Oral |