Evidence map›Paper›PMID 33732977›Full record

ArticleKidney international reports2021

Roxadustat for CKD-related Anemia in Non-dialysis Patients.

Daniel W Coyne, Simon D Roger, Sug Kyun Shin, Sung Gyun Kim, Andres A Cadena, Moustafa A Moustafa, Tak Mao Chan, Anatole Besarab, Willis Chou, Charles Bradley and 6 more

Retracted Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Kidney international reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It has been retracted, and should not be counted. It is linked to trial NCT01750190 (A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Roxadustat), which is not on this map. Cited by 69 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 14 pooled it
8.1field-weighted citation impact, top 2% 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.

NCT01750190 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Roxadustat (FG-4592) for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

TypeinterventionalSponsorKyntra BioRan2012 to 2018Enrolled922ConditionsCKD AnemiaArmsRoxadustat, Placebo
3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 14 syntheses or guidelines pooled it, 107 citations in OpenAlex.

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  20. Roxadustat for the treatment of anaemia in chronic kidney disease patients not on dialysis: a Phase 3, randomized, open-label, active-controlled study (DOLOMITES).Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2021
    Trial

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 6 countries.

Daniel W CoyneDivision of Nephrology, Washington University School of Medicine, St. Louis, Missouri, USA.
Simon D RogerRenal Unit, Renal Research, Gosford, NSW, Australia.
Sug Kyun ShinKidney Center, Ilsan Hospital NHIS, Goyang-si, Gyeongeei-Do, Republic of Korea.
Sung Gyun KimDepartment of Internal Medicine, Hallym University, Chuncheon, Republic of Korea.
Andres A CadenaDepartment of Internal Medicine, Clinica de la Costa, Barranquilla, Colombia.
Moustafa A MoustafaSouth Carolina Nephrology and Hypertension Center, Inc., Orangeburg, South Carolina, USA.
Tak Mao ChanDepartment of Medicine, University of Hong Kong, Queen Mary Hospital, HKSAR, Hong Kong, China.
Anatole BesarabSchool of Medicine Center for Neuroscience in Women's Health, Stanford University, Palo Alto, California, USA.
Willis ChouDepartment of Clinical Development, FibroGen, Inc., San Francisco, California, USA.
Charles BradleyDepartment of Clinical Development, FibroGen, Inc., San Francisco, California, USA.
Meraf EyassuDepartment of Clinical Operations, FibroGen, Inc., San Francisco, California, USA.
Robert LeongDepartment of Clinical Development, FibroGen, Inc., San Francisco, California, USA.
Tyson T LeeDepartment of Biometrics, FibroGen, Inc., San Francisco, California, USA.
Khalil G SaikaliDepartment of Biometrics, FibroGen, Inc., San Francisco, California, USA.
Lynda SzczechDepartment of Clinical Development, FibroGen, Inc., San Francisco, California, USA.
Kin-Hung P YuDepartment of Clinical Development, FibroGen, Inc., San Francisco, California, USA.
FibroGen (United States) · USGosford Hospital · AUHallym University · KRNational Health Insurance Service Ilsan Hospital · KRQueen Mary Hospital · CNStanford University · USUniversity of the Coast · COWashington University in St. Louis · USZimmer Biomet (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRoxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and improves iron metabolism. We assessed the efficacy and tolerability of roxadustat in patients with chronic kidney disease (CKD)-related anemia not on dialysis.

methodsANDES was a global Phase 3 randomized study in which adults with stage 3-5 CKD not on dialysis received roxadustat or placebo. Patients were initially dosed thrice weekly; dose was titrated to achieve a hemoglobin level ≥11.0 g/dl, followed by titration for maintenance. The primary endpoints were change in hemoglobin (weeks 28-52) and proportion of patients achieving a hemoglobin response (hemoglobin ≥11.0 g/dl and increase ≥1.0 g/dl [baseline >8.0 g/dl], or increase ≥2.0 g/dl [baseline ≤8.0 g/dl]) (week 24). Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were recorded.

resultsIn roxadustat (n = 616) and placebo (n = 306) groups, hemoglobin mean (SD) change from baseline over weeks 28-52 was significantly larger for roxadustat (2.00 [0.95]) versus placebo (0.16 [0.90]), corresponding to least-squares mean difference of 1.85 g/dl (95% confidence interval [CI] 1.74-1.97;

conclusionThis study showed that roxadustat corrected and maintained hemoglobin and was well tolerated in patients with CKD-related anemia not on dialysis (ClinicalTrials.gov NCT01750190).

Indexed as

anemiachronic kidney diseaserescue therapyroxadustat

Identifiers

PMID33732977
PMCPMC7938196
OpenAlexW3112489277

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.