Evidence map›Paper›PMID 40303227›Full record

ArticleKidney international reports2025

Randomized Trial of Lower-Dose Roxadustat Efficacy and Safety in Non-Dialysis-Dependent CKD-Associated Anemia.

Ping Li, Xuefeng Sun, Li Zhang, Hongli Lin, Niansong Wang, Yuehong Li, Sumei Zhao, Ping Fu, Hong Cheng, Zhiyong Guo and 10 more

Abstract read
In one paragraph

Article in Kidney international reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Ping LiDepartment of Nephrology, First Medical Center of Chinese PLA General Hospital, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Medical Devices and Integrated Traditional Chinese and Western Drug Development for Severe Kidney Diseases, Beijing Key Laboratory of Digital Intelligent TCM for the Prevention and Treatment of Pan-vascular Diseases, Key Disciplines of National Administration of Traditional Chinese Medicine (zyyzdxk-2023310), Beijing, China.
Xuefeng SunDepartment of Nephrology, First Medical Center of Chinese PLA General Hospital, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Medical Devices and Integrated Traditional Chinese and Western Drug Development for Severe Kidney Diseases, Beijing Key Laboratory of Digital Intelligent TCM for the Prevention and Treatment of Pan-vascular Diseases, Key Disciplines of National Administration of Traditional Chinese Medicine (zyyzdxk-2023310), Beijing, China.
Li ZhangDepartment of Nephrology, First Medical Center of Chinese PLA General Hospital, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Medical Devices and Integrated Traditional Chinese and Western Drug Development for Severe Kidney Diseases, Beijing Key Laboratory of Digital Intelligent TCM for the Prevention and Treatment of Pan-vascular Diseases, Key Disciplines of National Administration of Traditional Chinese Medicine (zyyzdxk-2023310), Beijing, China.
Hongli LinDepartment of Nephrology, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China.
Niansong WangDepartment of Nephrology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, China.
Yuehong LiDepartment of Nephrology, Beijing Tsinghua Changgung Hospital, Clinical Medicine of Tsinghua University, Beijing, China.
Sumei ZhaoDepartment of Nephrology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.
Ping FuDepartment of Nephrology, West China Hospital, Sichuan University, Chengdu, China.
Hong ChengDepartment of Nephrology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
Zhiyong GuoDepartment of Nephrology, The First Affiliated Hospital of Naval Medical University, Changhai Hospital, Shanghai, China.
Wanhong LuDepartment of Nephrology, The First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an, China.
Yani HeDepartment of Nephrology, Army Medical Center of Chinese People's Liberation Army, Chongqing, China.
Fengmin ShaoDepartment of Nephrology, Henan Provincial People's Hospital, Zhengzhou, China.
Qiang HeDepartment of Nephrology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang Provincial Hospital of Traditional Chinese Medicine, Hangzhou, China.
Yiqing WuMedical Affairs and Clinical Biometrics Department, FibroGen (China) Medical Technology Development Company Ltd., Beijing, China.
Cuihua HuangMedical Affairs and Clinical Biometrics Department, FibroGen (China) Medical Technology Development Company Ltd., Beijing, China.
Shuting PanMedical Affairs and Clinical Biometrics Department, FibroGen (China) Medical Technology Development Company Ltd., Beijing, China.
Guangyan CaiDepartment of Nephrology, First Medical Center of Chinese PLA General Hospital, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Medical Devices and Integrated Traditional Chinese and Western Drug Development for Severe Kidney Diseases, Beijing Key Laboratory of Digital Intelligent TCM for the Prevention and Treatment of Pan-vascular Diseases, Key Disciplines of National Administration of Traditional Chinese Medicine (zyyzdxk-2023310), Beijing, China.
Xiangmei ChenDepartment of Nephrology, First Medical Center of Chinese PLA General Hospital, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Medical Devices and Integrated Traditional Chinese and Western Drug Development for Severe Kidney Diseases, Beijing Key Laboratory of Digital Intelligent TCM for the Prevention and Treatment of Pan-vascular Diseases, Key Disciplines of National Administration of Traditional Chinese Medicine (zyyzdxk-2023310), Beijing, China.
FGCL-4592-858 Working Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Different starting doses of roxadustat are used for treating anemia in chronic kidney disease (CKD). We tested the noninferiority of weight-based lower starting dose compared with standard starting dose roxadustat for anemia in stage 3 to 5 CKD without dialysis. Methods: Patients were randomized (1:1) and stratified by CKD stage to receive weight-based standard (< 60 kg: 70 mg 3 times per week [TIW]; ≥ 60 kg: 100 mg TIW) or 1-step-lower (< 60 kg: 50 mg TIW; ≥ 60 kg: 70 mg TIW) roxadustat starting dose for 16 weeks. The primary endpoint was mean hemoglobin change from baseline over weeks 12 to 16. The secondary endpoints included the proportion achieving hemoglobin 100 to 120 g/l, hemoglobin variability, and rescue therapy. Results: Overall, 254 patients were randomized. The mean (SD) baseline hemoglobin was 89.88 (6.90) g/l. Most patients had stage 4 (39.0%) or stage 5 (40.2%) CKD. Mean hemoglobin increased from baseline at weeks 12 to 16 (lower: 21.57 g/l; standard: 26.35 g/l), but noninferiority was not met. A comparable proportion achieved hemoglobin of 100 to 120 g/l (lower: 46.0%; standard: 47.2%). The hemoglobin increase was comparable in CKD stage 3 to 4, but less with the lower dose in CKD stage 5 (17.28 vs. 26.71 g/l). The lower dose exhibited a lower hemoglobin rate of change (lower: 2.917; standard: 3.376) and less drug exposure. Drug-related adverse event rates were comparable. Conclusion: The proportion of patients who achieved the hemoglobin target was comparable between the doses. The lower starting dose had less hemoglobin fluctuation and is recommended for stage 3 to 4 CKD.

Indexed as

anemiachronic kidney diseaseefficacyhemoglobin variabilityroxadustat

Identifiers

PMID40303227
PMCPMC12034882

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.