Evidence map›Paper›PMID 21505096›Full record

Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2011

C.E.R.A. once every 4 weeks corrects anaemia and maintains haemoglobin in patients with chronic kidney disease not on dialysis.

Simon D Roger, Francesco Locatelli, Rainer P Woitas, Maurice Laville, Sheldon W Tobe, Robert Provenzano, Thomas A Golper, Prajej Ruangkanchanasetr, Ho Yung Lee, Kwan-Dun Wu and 5 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 6 pooled it
3.3field-weighted citation impact, top 7% 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

23 citing papers in PubMed, 6 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
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  5. Pooled it
  6. Darbepoetin for the anaemia of chronic kidney disease.The Cochrane database of systematic reviews · 2014
    Pooled it
  7. Trial
  8. Randomized placebo-controlled dose-ranging and pharmacodynamics study of roxadustat (FG-4592) to treat anemia in nondialysis-dependent chronic kidney disease (NDD-CKD) patients.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2015
    Trial
  9. Trial
  10. Article
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  12. Article
  13. Article
  14. Article
  15. Erythropoietin Resistance in Patients with Chronic Kidney Disease: Current Perspectives.International journal of nephrology and renovascular disease · 2020
    Review
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  17. Article
  18. Observational
  19. Article
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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

15 authors at 14 institutions in 13 countries.

Simon D RogerDepartment of Renal Medicine, Gosford Hospital, Gosford, Australia. sroger@nsccahs.health.nsw.gov.au
Francesco Locatelli
Rainer P Woitas
Maurice Laville
Sheldon W Tobe
Robert Provenzano
Thomas A Golper
Prajej Ruangkanchanasetr
Ho Yung Lee
Kwan-Dun Wu
Michal Nowicki
Agnes Ladanyi
Alberto Martínez-Castelao
Ulrich Beyer
Frank C Dougherty
Roche (Switzerland) · CHAlessandro Manzoni Hospital · ITBellvitge University Hospital · ESGosford Hospital · AUHôpital Edouard Herriot · FRMedical University of Lodz · PLNational Taiwan University Hospital · TWPéterfy Sándor Utcai Kórház-Rendelőintézet és Baleseti Központ · HUPhramongkutklao Hospital · THSt. John Hospital & Medical Center · USUniversity of Bonn · DEUniversity of Toronto · CAVanderbilt University Medical Center · USYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNo previous randomized controlled studies have been reported examining de novo, once every 4 weeks (Q4W) administration of erythropoiesis-stimulating agents in chronic kidney disease (CKD) patients. We report results from a randomized multinational study that compared continuous erythropoietin receptor activator (C.E.R.A.) Q4W with darbepoetin alfa once weekly (QW) or every 2 weeks (Q2W) for the correction of anaemia in non-dialysis CKD patients.

methodsPatients were randomized (1:1) to receive either 1.2 μg/kg C.E.R.A. Q4W or darbepoetin alfa QW/Q2W during a 20-week correction period and an 8-week evaluation period. Two primary end points were assessed: the haemoglobin (Hb) response rate and the change in average Hb concentration between baseline and evaluation.

resultsThe Hb response rate for C.E.R.A. was 94.1%, significantly higher than the protocol-specified 60% response rate [95% confidence interval (CI): 89.1, 97.3; P < 0.0001] and comparable with darbepoetin alfa (93.5%; 95% CI: 88.4, 96.8; P < 0.0001). C.E.R.A. Q4W was non-inferior to darbepoetin alfa QW/Q2W, with similar mean Hb changes from baseline of 1.62 g/dL and 1.66 g/dL, respectively. Patients receiving C.E.R.A. showed a steady rise in Hb, with fewer patients above the target range during the first 8 weeks compared with darbepoetin alfa [39 patients (25.8%) versus 72 patients (47.7%); P < 0.0001]. Adverse event rates were comparable between the treatment groups.

conclusionC.E.R.A. Q4W successfully corrects anaemia and maintains stable Hb levels within the recommended target range in non-dialysis CKD patients.

Indexed as

AgedAnemiaErythropoietinFemaleHemoglobinsHumansMalePolyethylene GlycolsRenal DialysisRenal Insufficiency, Chroniccontinuous erythropoietin receptor activatorErythropoietinHemoglobinsPolyethylene Glycols

Identifiers

PMID21505096
PMCPMC3224113
OpenAlexW2119341506

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.