Evidence map›Paper›PMID 20522670›Full record

Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2010

Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial.

Fernando Carrera, Charmaine E Lok, Angel de Francisco, Francesco Locatelli, Johannes F E Mann, Bernard Canaud, Peter G Kerr, Iain C Macdougall, Anatole Besarab, Giuseppe Villa and 6 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00394953 (A Randomized, Controlled, Open Label, Multicenter, Parallel-group Study to Compare the Effect of Mircera With That of Darbepoetin Alfa, Administered Intravenously at Extended Dosing Intervals, for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Hemodialysis), which is not on this map. Cited by 30 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 9 pooled it
5.4field-weighted citation impact, top 4% 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.

NCT00394953 phase3completednot on this map

A Randomized, Controlled, Open Label, Multicenter, Parallel-group Study to Compare the Effect of Mircera With That of Darbepoetin Alfa, Administered Intravenously at Extended Dosing Intervals, for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Hemodialysis

TypeinterventionalSponsorHoffmann-La RocheRan2006 to 2008Enrolled490ConditionsAnemiaArmsDarbepoetin alfa, methoxy polyethylene glycol-epoetin beta [Mircera]
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 9 syntheses or guidelines pooled it, 78 citations in OpenAlex.

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  8. Darbepoetin for the anaemia of chronic kidney disease.The Cochrane database of systematic reviews · 2014
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  12. C.E.R.A. once every 4 weeks corrects anaemia and maintains haemoglobin in patients with chronic kidney disease not on dialysis.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2011
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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

16 authors at 11 institutions in 10 countries.

Fernando CarreraEurodial, Dialysis Unit, Leiria, Portugal. fcarrera@mail.telepac.pt
Charmaine E Lok
Angel de Francisco
Francesco Locatelli
Johannes F E Mann
Bernard Canaud
Peter G Kerr
Iain C Macdougall
Anatole Besarab
Giuseppe Villa
Isabelle Kazes
Bruno Van Vlem
Shivinder Jolly
Ulrich Beyer
Frank C Dougherty
PATRONUS Investigators
Roche (Switzerland) · CHAlessandro Manzoni Hospital · ITAltice Portugal (Portugal) · PTCentre Hospitalier Universitaire de Reims · FRFondazione Salvatore Maugeri · ITHenry Ford Health System · USKing's College Hospital · GBMarqués de Valdecilla University Hospital · ESMonash Medical Centre · AUOnze Lieve Vrouwziekenhuis Hospital · BEToronto General Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSeveral studies with erythropoiesis-stimulating agents claim that maintenance therapy of renal anaemia may be possible at extended dosing intervals; however, few studies were randomized, results varied, and comparisons between agents were absent. We report results of a multi-national, randomized, prospective trial comparing haemoglobin maintenance with methoxy polyethylene glycol-epoetin beta and darbepoetin alfa administered once monthly.

methodsHaemodialysis patients (n = 490) on stable once-weekly intravenous darbepoetin alfa were randomized to methoxy polyethylene glycol-epoetin beta once monthly or darbepoetin alfa every 2 weeks for 26 weeks, with dose adjustment for individual haemoglobin target (11-13 g/dL; maximum decrease from baseline 1 g/dL). Subsequently, patients entered a second 26-week period of once-monthly methoxy polyethylene glycol-epoetin beta and darbepoetin alfa. The primary endpoint was the proportion of patients who maintained average haemoglobin ≥10.5 g/dL, with a decrease from baseline ≤1 g/dL, in Weeks 50-53; the secondary endpoint was dose change over time. The trial is registered at www.ClinicalTrials.gov, number NCT00394953.

resultsBaseline characteristics were similar between groups. One hundred and fifty-seven of 245 patients treated with methoxy polyethylene glycol-epoetin beta and 99 of 245 patients with darbepoetin alfa met the response definition (64.1% and 40.4%; P < 0.0001). Doses increased by 6.8% with methoxy polyethylene glycol-epoetin beta and 58.8% with darbepoetin alfa during once-monthly treatment. Death rates were equal between treatments (5.7%). Most common adverse events included hypertension, procedural hypotension, nasopharyngitis and muscle spasms, with no differences between groups.

conclusionsMethoxy polyethylene glycol-epoetin beta maintained target haemoglobin more successfully than darbepoetin alfa at once-monthly dosing intervals despite dose increases with darbepoetin alfa.

Indexed as

AgedAnemia, Iron-DeficiencyChronic DiseaseDarbepoetin alfaDose-Response Relationship, DrugDrug CarriersErythropoietinFemaleHematinicsHumansKidney DiseasesMaleMiddle AgedPolyethylene GlycolsRecombinant ProteinsRenal DialysisDarbepoetin alfaDrug Carriersepoetin betaErythropoietinHematinicsmonomethoxypolyethylene glycolPolyethylene GlycolsRecombinant Proteins

Identifiers

PMID20522670
PMCPMC2989790
OpenAlexW2158383145

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.