Evidence map›Paper›PMID 26482252›Full record

Trial reportPediatric nephrology (Berlin, Germany)2016

Safety and usage of darbepoetin alfa in children with chronic kidney disease: prospective registry study.

Franz Schaefer, Bernd Hoppe, Therese Jungraithmayr, Günter Klaus, Lars Pape, Mourad Farouk, Janet Addison, Nick Manamley, Karel Vondrak

Open access · hybridAbstract readClinical Trial, Phase IVMulticenter StudyObservational Study
In one paragraph

Trial report in Pediatric nephrology (Berlin, Germany), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 10% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Anemia in chronic kidney disease.Pediatric nephrology (Berlin, Germany) · 2018
    Review
  7. Article
  8. Article
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

9 authors at 8 institutions in 5 countries.

Franz SchaeferUniversity of Heidelberg, Heidelberg, Germany. franz.schaefer@med.uni-heidelberg.de.
Bernd HoppeUniversity Hospital Bonn, Bonn, Germany.
Therese JungraithmayrMedical University of Innsbruck, Innsbruck, Austria.
Günter KlausUniversity of Marburg, Marburg, Germany.
Lars PapeHannover Medical School, Hannover, Germany.
Mourad FaroukAmgen (Europe) GmbH, Zug, Switzerland.
Janet AddisonAmgen Ltd, Cambridge, UK.
Nick ManamleyAmgen Ltd, Cambridge, UK.
Karel VondrakUniversity Hospital Motol, Prague, Czech Republic.
Amgen (United Kingdom) · GBAmgen (Switzerland) · CHHeidelberg University · DEMedizinische Hochschule Hannover · DEPhilipps University of Marburg · DEUniversität Innsbruck · ATUniversity Hospital Bonn · DEUniversity Hospital in Motol · CZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLimited prospective data are available on the long-term safety of darbepoetin alfa (DA) for treating anemia in children with chronic kidney disease (CKD).

methodsIn this prospective, phase IV, observational registry study, children ≤16 years of age with CKD anemia and receiving DA were observed for ≤2 years. Adverse events (AEs), DA dosing, hemoglobin (Hb) concentrations, and transfusions were recorded.

resultsA total of 319 patients were included in the analysis (mean age, 9.1 years), 158 (49.5%) of whom were on dialysis at study entry. Of 434 serious AEs reported in 162 children, the most common were peritonitis (10.0%), gastroenteritis (6.0%), and hypertension (4.1%). Six patients (1.9%) died (unrelated to DA). Four patients (1.3%) experienced six serious adverse drug reactions. The geometric mean DA dose range was 1.4-2.0 μg/kg/month. Mean baseline Hb concentration was 11.1 g/dl; mean values for children receiving and not receiving dialysis at baseline ranged between 10.9 and 11.5 g/dl and 11.2-11.7 g/dl, respectively. Overall, 48 patients (15.0%) received ≥1 transfusion.

conclusionsNo new safety signals for DA were identified in children receiving DA for CKD anemia for ≤2 years. Based on Hb concentrations and transfusion requirements, DA was effective at managing anemia in these patients.

Indexed as

Renal DialysisAdolescentAge FactorsAnemiaBiomarkersBlood TransfusionChildChild, PreschoolDarbepoetin alfaEuropeFemaleHematinicsHemoglobinsHumansInfantMaleBiomarkersDarbepoetin alfaHematinicsHemoglobinsAdverse eventsAnemiaChronic kidney diseaseDarbepoetin alfaHemoglobinPediatric

Identifiers

PMID26482252
PMCPMC4756039
OpenAlexW2196114595

What OpenQuestion holds

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LicenceCC BY
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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.