NANLING - Roxadustat Effectiveness/Safety in Chronic Kidney Disease-Associated Anemia with Peritoneal Dialysis

Q: What is the purpose of this study?

To evaluate the effectiveness and safety of oral roxadustat for CKD-associated anemia in Chinese patients receiving peritoneal dialysis.

Q: How was roxadustat administered and for how long?

Patients received roxadustat three times weekly for 24 weeks in this phase 4 study.

Q: What hemoglobin endpoint was used to measure effectiveness?

The primary effectiveness measure reported was the proportion achieving hemoglobin concentration ≥100 g/L at Weeks 20 and 24, overall and by T2DM status.

Q: Did roxadustat safety results align with expectations?

Treatment-emergent adverse events occurred in 81.0% of patients, and roxadustat-related events occurred in 10.3%, consistent with roxadustat’s known safety profile and PD patient characteristics.

Sep 29, 2026

Uploaded by dabgoudw

Oral anemia therapies are preferred by patients receiving home-based peritoneal dialysis (PD). This phase 4 study assessed the effectiveness and safety of oral roxadustat in Chinese patients with chronic kidney disease (CKD)-associated anemia on PD. Patients received roxadustat thrice weekly for 24 weeks, evaluating hemoglobin response (including stratification by type 2 diabetes mellitus), quality-of-life changes via FACT-An and SF-36, and treatment-emergent adverse events. Roxadustat corrected anemia regardless of baseline T2DM, with adverse events consistent with the known safety profile.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages17

Reading Time43 min

AccessFree to download

Introduction

Study methods and outcomes

Results

Conclusion

Kidney Diseases Research Article Kidney Dis 2026;12:1–17 DOI: 10. 1159/000549723 Received: June 30, 2025 Accepted: October 29, 2025 Published online: November 24, 2025 NANLING: Roxadustat Effectiveness/Safety in Chronic Kidney Disease-Associated Anemia with Peritoneal Dialysis Zhiming Yea Gang Xu b Hao Zhang c Liang Wangd Aiping Yine Hong Liu f Xiao Yangg Hui Zhongh Fei Xiongi Zhenhua Yangj Jie Dongk Hongtao Yangl Yiqing Wu m Cuihua Huang m Shuting Pan n Xueqing Yu a on behalf ofthe NANLING Working Group aDepartment of Nephrology, Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, PR China; bDepartment of Nephrology, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, PR China; cDepartment of Nephrology, The Third Xiangya Hospital of Central South University, Changsha, PR China; dDepartment of Nephrology, The Affiliated Wuxi People’s Hospital of Nanjing Medical University, Wuxi People’s Hospital, Wuxi Medical Center, Nanjing Medical University, Wuxi, PR China; eDepartment of Nephrology, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, PR China; fDepartment of Nephrology, The Second Xiangya Hospital of Central South University, Changsha, PR China; gDepartment of Nephrology, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, PR China; hDepartment of Nephrology, West China Hospital of Sichuan University, Chengdu, PR China; iDepartment of Nephrology, Wuhan No. 1 Hospital, Wuhan, PR China; jDepartment of Nephrology, The First Affiliated Hospital of Guangxi Medical University, Nanning, PR China; kDepartment of Nephrology, Peking University First Hospital, Beijing, PR China; lDepartment of Nephrology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, PR China; mMedical Affairs Department, FibroGen (China), Medical Technology Development Co. Ltd., Beijing, PR China; nClinical Biometrics Department, FibroGen (China), Medical Technology Development Co. Ltd., Beijing, PR China Keywords Anemia · Chronic kidney disease · Peritoneal dialysis · Roxadustat · Type 2 diabetes Abstract Introduction: Oral anemia treatments are preferred by patients on home-based peritoneal dialysis (PD). We evaluated the effectiveness and safety of oral roxadustat in Chinese patients with chronic kidney disease (CKD)-associated anemia on PD. Methods: In this phase 4 study, patients with CKD-anemia on PD received roxadustat thrice weekly for 24 weeks. We assessed the proportion with hemoglobin ≥100 g/L at Weeks 20 and 24 (overall and stratified by type 2 diabetes mellitus [T2DM] vs. nondiabetes mellitus [DM]), quality of life changes according to the Functional Assessment of Cancer Therapy-Anemia (FACT-An), and 36-Item Short Form Health Survey (SF-36), and safety. Results: Overall, 195 patients (116 male [59.5%]; mean ± standard deviation age, 46.3 ± 12.3 years) were enrolled; 189 Trial registration: China Clinical Trial Registry (ChiCTR2100044799, [https://www.chictr.org.cn/](https://www.chictr.org.cn/)). The individual names of the NANLING Working Group members are provided in the online supplementary material. [karger@karger.com](karger@karger.com)[ ](karger@karger.com)[www.karger.com/kdd](www.karger.com/kdd) © 2025 The Author(s) . Published by S. Karger AG, Basel Correspondence to: Xueqing Yu, yuxueqing [gdph.org.cn](gdph.org.cn) This article is licensed under the Creative Commons AttributionNonCommercial 4.0 International License (CC BY-NC) ([https://www](https://www). [karger.com/Services/OpenAccessLicense](karger.com/Services/OpenAccessLicense)). Usage and distribution for commercial purposes requires written permission. (96.9%) were erythropoiesis-stimulating agent-treated and 43 (22.1%) had T2DM. Baseline hemoglobin was 98.1 ± 10.7 g/Land was <80 g/L in 10 (5.1%). The mean (95% confidence interval) proportion who achieved a hemogl

FAQs

What is the purpose of this study?

To evaluate the effectiveness and safety of oral roxadustat for CKD-associated anemia in Chinese patients receiving peritoneal dialysis.

How was roxadustat administered and for how long?

Patients received roxadustat three times weekly for 24 weeks in this phase 4 study.

What hemoglobin endpoint was used to measure effectiveness?

The primary effectiveness measure reported was the proportion achieving hemoglobin concentration ≥100 g/L at Weeks 20 and 24, overall and by T2DM status.

Did roxadustat safety results align with expectations?

Treatment-emergent adverse events occurred in 81.0% of patients, and roxadustat-related events occurred in 10.3%, consistent with roxadustat’s known safety profile and PD patient characteristics.

Sep 29, 2026

Uploaded by dabgoudw