Evidence map›Paper›PMID 21212421›Full record

Trial reportClinical journal of the American Society of Nephrology : CJASN2011

Darbepoetin alfa impact on health status in diabetes patients with kidney disease: a randomized trial.

Eldrin F Lewis, Marc A Pfeffer, Amy Feng, Hajime Uno, John J V McMurray, Robert Toto, Shravanthi R Gandra, Scott D Solomon, Moustafa Moustafa, Iain C Macdougall and 3 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical journal of the American Society of Nephrology : CJASN, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00093015 (Trial to Reduce Cardiovascular Events With Aranesp® Therapy), which is not on this map. Cited by 30 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 6 pooled it
–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.

NCT00093015 phase3completednot on this map

Trial to Reduce Cardiovascular Events With Aranesp® Therapy

TypeinterventionalSponsorAmgenRan2004 to 2009Enrolled4,038ConditionsKidney Disease, Diabetes Mellitus, AnemiaArmsPlacebo, darbepoetin alfa
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Interventions for fatigue in people with kidney failure requiring dialysis.The Cochrane database of systematic reviews · 2023
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  6. Darbepoetin for the anaemia of chronic kidney disease.The Cochrane database of systematic reviews · 2014
    Pooled it
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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

13 authors.

Eldrin F LewisCardiovascular Division, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA. eflewis@partners.org
Marc A Pfeffer
Amy Feng
Hajime Uno
John J V McMurray
Robert Toto
Shravanthi R Gandra
Scott D Solomon
Moustafa Moustafa
Iain C Macdougall
Francesco Locatelli
Patrick S Parfrey
TREAT Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesQuality of life (QOL) is markedly impaired in patients with anemia, diabetes mellitus, and chronic kidney disease. Limited data exist regarding the effect of anemia treatment on patient perceptions. The objectives were to determine the longitudinal impact of anemia treatment on quality of life in patients with diabetes and chronic kidney disease and to determine the predictors of baseline and change in QOL. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In a large, double blind study, patients with type 2 diabetes mellitus, nondialysis chronic kidney disease (estimated GFR, 20 to 60 ml/min per 1.73 m(2)), and anemia (hemoglobin 10.4 g/dl) were randomized to darbepoetin alfa or placebo. QOL was measured with Functional Assessment of Cancer Therapy-Fatigue, Short Form-36, and EuroQol scores over 97 weeks.

resultsPatients randomized to darbepoetin alfa reported significant improvements compared with placebo patients in Functional Assessment of Cancer Therapy-Fatigue, and EuroQol scores visual analog scores, persisting through 97 weeks. No consistent differences in Short Form-36 were noted. Consistent predictors of worse change scores include lower activity level, older age, pulmonary disease, and duration of diabetes. Interim stroke had a substantial negative impact on fatigue and physical function.

conclusionDarbepoetin alfa confers a consistent, but small, improvement in fatigue and overall quality of life but not in other domains. These modest QOL benefits must be considered in the context of neutral overall effect and increased risk of stroke in a small proportion of patients. Patient's QOL and potential treatment risk should be considered in any treatment decision.

Indexed as

Diabetes ComplicationsHealth StatusQuality of LifeAgedAnemiaDarbepoetin alfaDouble-Blind MethodErythropoietinFemaleHumansKidney DiseasesMaleMiddle AgedDarbepoetin alfaErythropoietin

Identifiers

PMID21212421
PMCPMC3069378

What OpenQuestion holds

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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.