Evidence map›Paper›PMID 28371815›Full record

Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2017

Phase 2 studies of oral hypoxia-inducible factor prolyl hydroxylase inhibitor FG-4592 for treatment of anemia in China.

Nan Chen, Jiaqi Qian, Jianghua Chen, Xueqing Yu, Changlin Mei, Chuanming Hao, Gengru Jiang, Hongli Lin, Xinzhou Zhang, Li Zuo and 11 more

Open access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 117 papers, 22 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
117citing papers in PubMed, 22 pooled it
14.4field-weighted citation impact, top 1% of its field
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

117 citing papers in PubMed, 22 syntheses or guidelines pooled it, 195 citations in OpenAlex.

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57 more citing papers are in PubMed but not listed here.

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

21 authors at 13 institutions in 2 countries.

Nan ChenInstitute of Nephrology, Department of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Jiaqi QianRenji Hospital, Shanghai, China.
Jianghua ChenZhejiang University, Hangzhou, China.
Xueqing YuSun Yat-Sen University, Guangzhou, China.
Changlin MeiChangzheng Hospital, Shanghai, China.
Chuanming HaoShanghai Huashan Hospital, Shanghai, China.
Gengru JiangXinhua Hospital, Jiaotong University, Shanghai, China.
Hongli LinDalian Medical University, Dalian, China.
Xinzhou ZhangShenzhen People's Hospital, Shenzhen, China.
Li ZuoBeijing University First Hospital, Beijing, China.
Qiang HeSichuan Province Hospital, Chengdu, China.
Ping FuWest China Hospital, Chengdu, China.
Xuemei LiUnion Medical College Hospital, Beijing, China.
Dalvin NiFibroGen, Inc., San Francisco, CA, USA.
Stefan HemmerichFibroGen, Inc., San Francisco, CA, USA.
Cameron LiuFibroGen, Inc., San Francisco, CA, USA.
Lynda SzczechFibroGen, Inc., San Francisco, CA, USA.
Anatole BesarabFibroGen, Inc., San Francisco, CA, USA.
Thomas B NeffFibroGen, Inc., San Francisco, CA, USA.
Kin-Hung Peony YuFibroGen, Inc., San Francisco, CA, USA.
Frank H ValoneFibroGen, Inc., San Francisco, CA, USA.
FibroGen (United States) · USChinese Academy of Medical Sciences & Peking Union Medical College · CNDalian Medical University · CNHuashan Hospital · CNPeking University First Hospital · CNRenji Hospital · CNShanghai Changzheng Hospital · CNShanghai Jiao Tong University · CNShenZhen People’s Hospital · CNSichuan University · CNSun Yat-sen University · CNXinHua Hospital · CNZhejiang University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFG-4592 (roxadustat) is an oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (HIF-PHI) promoting coordinated erythropoiesis through the transcription factor HIF. Two Phase 2 studies were conducted in China to explore the safety and efficacy of FG-4592 (USAN name: roxadustat, CDAN name: ), a HIF-PHI, in patients with anemia of chronic kidney disease (CKD), both patients who were dialysis-dependent (DD) and patients who were not dialysis-dependent (NDD).

methodsIn the NDD study, 91 participants were randomized to low (1.1-1.75 mg/kg) or high (1.50-2.25 mg/kg) FG-4592 starting doses or to placebo. In the DD study, 87 were enrolled to low (1.1-1.8 mg/kg), medium (1.5-2.3 mg/kg) and high (1.7-2.3 mg/kg) starting FG-4592 doses or to continuation of epoetin alfa. In both studies, only oral iron supplementation was allowed.

resultsIn the NDD study, hemoglobin (Hb) increase ≥1 g/dL from baseline was achieved in 80.0% of subjects in the low-dose cohort and 87.1% in the high-dose cohort, versus 23.3% in the placebo arm (P < 0.0001, both). In the DD study, 59.1%, 88.9% (P = 0.008) and 100% (P = 0.0003) of the low-, medium- and high-dose subjects maintained their Hb levels after 5- and 6-weeks versus 50% of the epoetin alfa-treated subjects. In both studies, significant reductions in cholesterol were noted in FG-4592-treated subjects, with stability or increases in serum iron, total iron-binding capacity (TIBC) and transferrin (without intravenous iron administration). In the NDD study, hepcidin levels were significantly reduced across all FG-4592-treated arms as compared with no change in the placebo arm. In the DD study, hepcidin levels were also reduced in a statistically significant dose-dependent manner in the highest dose group as compared with the epoetin alfa-treated group. Adverse events were similar for FG-4592-treated and control subjects.

conclusionsFG-4592 may prove an effective alternative for managing anemia of CKD. It is currently being investigated in a pivotal global Phase 3 program.

Indexed as

AdolescentAdultAgedAged, 80 and overAnemiaCohort StudiesDouble-Blind MethodFemaleGlycineHumansHypoxia-Inducible Factor-Proline DioxygenasesIsoquinolinesMaleMiddle AgedRenal DialysisRenal Insufficiency, ChronicEGLN2 protein, humanGlycineHypoxia-Inducible Factor-Proline DioxygenasesIsoquinolinesroxadustatanemia in chronic kidney diseaseerythropoiesiserythropoietinFG-4592hypoxia-inducible factor

Identifiers

PMID28371815
PMCPMC5837707
OpenAlexW2599499085

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Registered trials

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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.