Long-term safety and effectiveness of roxadustat in Chinese patients with chronic kidney disease-associated anemia: The ROXSTAR registry.
10.1097/CM9.0000000000003672
- Author:
Xiaoying DU
1
;
Yaomin WANG
1
;
Haifeng YU
2
;
Jurong YANG
3
;
Weiming HE
4
;
Zunsong WANG
5
;
Dongwen ZHENG
6
;
Xiaowei LI
7
;
Shuijuan SHEN
8
;
Dong SUN
9
;
Weimin YU
10
;
Detian LI
11
;
Changyun QIAN
12
;
Yiqing WU
12
;
Shuting PAN
12
;
Jianghua CHEN
1
Author Information
1. Kidney Disease Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310003, China.
2. Department of Nephrology, Taizhou Central Hospital, Taizhou, Zhejiang 318001, China.
3. Department of Nephrology, The Third Affiliated Hospital of Chongqing Medical University, Chongqing 401120, China.
4. Department of Nephrology, Jiangsu Provincial Hospital of Chinese Medicine, Nanjing, Jiangsu 210029, China.
5. Department of Nephrology, Shandong Provincial Qianfoshan Hospital, The First Affiliated Hospital of Shandong First Medical University, Jinan, Shandong 250000, China.
6. Department of Nephrology, The Tenth Affiliated Hospital of Southern Medical University (Dongguan People's Hospital), Dongguan, Guangdong 523059, China.
7. Department of Nephrology, Fuyang People's Hospital, Fuyang, Anhui 236001, China.
8. Department of Nephrology, Shaoxing People's Hospital, Shaoxing, Zhejiang 312300, China.
9. Department of Nephrology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu 221006, China.
10. Department of Nephrology, Shanxi Bethune Hospital, Taiyuan, Shanxi 030032, China.
11. Department of Nephrology, Shenjing Hospital of China Medical University, Shenyang, Liaoning 110801, China.
12. Department of Medical Affairs, FibroGen (China) Medical Technology Development Co., Ltd., Shanghai 200120, China.
- Publication Type:Clinical Trial, Phase IV
- Keywords:
Anemia;
Chronic kidney disease;
Effectiveness;
Roxadustat;
Safety
- MeSH:
Humans;
Male;
Female;
Anemia/etiology*;
Middle Aged;
Renal Insufficiency, Chronic/complications*;
Glycine/adverse effects*;
Isoquinolines/adverse effects*;
Aged;
Prospective Studies;
Adult;
Hemoglobins/metabolism*;
Treatment Outcome;
China;
Registries;
East Asian People
- From:
Chinese Medical Journal
2025;138(12):1465-1476
- CountryChina
- Language:English
-
Abstract:
BACKGROUND:Chronic kidney disease (CKD)-associated anemia (CKD-anemia) is associated with poor survival, and hemoglobin targets are often not achieved with current therapies. Phase 3 trials have demonstrated the treatment efficacy of roxadustat for CKD-anemia. This phase 4 study aims to evaluate the long-term (52-week) safety and effectiveness of roxadustat in a broad real-world patient population with CKD-anemia with and without dialysis in China.
METHODS:This Phase 4 multicenter, open-label, prospective study, conducted from 24 November 2020 to 11 November 2022, evaluated the long-term safety and effectiveness of roxadustat for CKD-anemia in China. Patients aged ≥18 years with CKD-anemia with or without dialysis were included. The initial oral dose was 70-120 mg (weight-based followed by dose adjustment) over 52 weeks. The primary endpoint was safety based on adverse events (AEs). The secondary endpoints were hemoglobin changes from baseline and the proportion of patients who achieved mean hemoglobin ≥100 g/L. Effectiveness evaluable populations 1 (EE1) and EE2 included roxadustat-naïve and previously roxadustat-treated patients, respectively. The safety analysis set (SAF) included all patients who received ≥1 occasion.
RESULTS:The EE1, EE2, and SAF populations included 1804, 193, and 2021 patients, respectively. In the SAF, the mean age was 50 ± 14 years, and 1087 patients (53.8%) were male. Mean baseline hemoglobin was 96.9 ± 14.0 g/L in EE1 and 100.3 ± 12.9 g/L in EE2. In EE1, the mean (95% confidence interval) hemoglobin changes from baseline over weeks 24-36 and 36-52 were 14.2 (13.5-14.9) g/L and 14.3 (13.5-15.0) g/L, respectively. Over weeks 24-36 and 36-52, 83.3% and 86.1% of patients in EE1 and 82.7% and 84.7% in EE2 achieved mean hemoglobin ≥100 g/L, respectively. In the SAF, 1643 (81.3%) patients experienced treatment-emergent AEs (TEAEs). Overall, 219 (10.8%) patients experienced drug-related TEAEs. Thirty-eight (1.9%) patients died of TEAEs (unrelated to the study drug). Vascular access thrombosis was uncommon.
CONCLUSIONS:Roxadustat (52 weeks) increased hemoglobin and maintained the treatment target in Chinese patients with CKD-anemia with acceptable safety, supporting its use in real-world settings.
REGISTRATION:Chinese Clinical Trial Registry ( www.chictr.org.cn ) ChiCTR2100046322; CDE ( www.chinadrugtrials.org.cn ) CTR20201568.
