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A clinical study on roxadustat for anemia in diabetic nephropathy: a 8-week study

  • Nephrology - Original Paper
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Abstract

Purpose

The development of roxadustat is a standard treatment for renal anemia, and multiple clinical trials have proved its safety and efficacy. However, less information is available from trials of the population with diabetic nephropathy (DN). This study aimed to determine whether roxadustat is effective for treating DN.

Methods

This was a single-center, retrospective, institutional review board-approved cohort study. The patients with DN were chosen and given roxadustat or erythropoietin (EPO) for 8 weeks. The mean hemoglobin (Hb) level after 8 weeks of treatment served as the primary outcome. Alterations in the iron index and lipid levels were considered secondary objectives. Sub-group analysis was performed to observe the impact of inflammation and glycemic status on Hb.

Results

A total of 80 patients were enrolled, 40 in each group. After 8 weeks of treatment, the Hb levels in the roxadustat group were higher than those in the control group. The number of patients who achieved Hb response was higher in the roxadustat group than in the control group (77.5% versus 27.5%; P < 0.001). In addition to lowering total cholesterol and low-density lipoprotein cholesterol, roxadustat decreased ferritin and elevated total iron-binding capacity. Compared to the control group, roxadustat was more beneficial for patients with an inflammatory condition and poor glycemic control.

Conclusions

Roxadustat treatment remarkably corrected anemia in patients with DN, and its effectiveness was unaffected by inflammation or glycemic control levels. In addition, roxadustat can also reduce a patient's blood lipid level and enhance the body's use of iron.

Clinical trial registration

ChiCTR2200057232.

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Funding

This work (research, review, or writing) required no funding of any type from any agency in the public, commercial, or not-for-profit sectors.

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Authors and Affiliations

  1. Department of Nephrology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, 221002, China

    Luhua Jiang, Zhifang Zheng, Xuejie Zhang, Yizhou Xu, Ashok Raj & Dong Sun

  2. Department of Urology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, 221002, China

    Ashok Raj

  3. Department of Internal Medicine and Diagnostics, Xuzhou Medical University, Xuzhou, 221002, China

    Dong Sun

  4. Department of Nephrology, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai West Road, Quanshan District, Xuzhou, 221001, China

    Dong Sun

  5. National Clinical Research Center of Kidney Diseases, Affiliated Jinling Hospital, Medical School, Nanjing University, Nanjing, 210002, China

    Ruoyu Jia

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  1. Luhua Jiang
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Correspondence to Dong Sun.

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Jiang, L., Jia, R., Zheng, Z. et al. A clinical study on roxadustat for anemia in diabetic nephropathy: a 8-week study. Int Urol Nephrol 56, 1093–1101 (2024). https://doi.org/10.1007/s11255-023-03757-0

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