Evidence map›Paper›PMID 25925701›Full record

Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2015

A randomized, open-label trial of iron isomaltoside 1000 (Monofer®) compared with iron sucrose (Venofer®) as maintenance therapy in haemodialysis patients.

Sunil Bhandari, Philip A Kalra, Jatin Kothari, Patrice M Ambühl, Jeppe H Christensen, Ashot M Essaian, Lars L Thomsen, Iain C Macdougall, Daniel W Coyne

Registry-linked trialOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06830941 (Efficacy and Safety of Iron Isomaltoside in the Treatment of Peritoneal Dialysis Patients with Renal Related Anemia), which is not on this map. Cited by 40 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 4 pooled it
4.2field-weighted citation impact, top 6% 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.

NCT06830941 phase4not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Efficacy and Safety of Iron Isomaltoside in the Treatment of Peritoneal Dialysis Patients with Renal Related Anemia: a Randomized Controlled Trial

TypeinterventionalSponsorXie Jingyuan, MDRan2025 to 2027Enrolled124ConditionsRenal Anemia, Peritoneal Dialysis (PD)ArmsIron isomaltoside, Ferrous succinate
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 4 syntheses or guidelines pooled it, 78 citations in OpenAlex.

  1. Guideline
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  5. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2021
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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

9 authors at 9 institutions in 6 countries.

Sunil BhandariHull and East Yorkshire Hospitals NHS Trust, Hull, UK.
Philip A KalraSalford Royal NHS Foundation Trust, Salford, UK.
Jatin KothariP. D. Hinduja National Hospital and Research Center Mumbai, Mumbai, India.
Patrice M AmbühlLeiter Abteilung Nephrologie, Stadtspital Waid Zürich, Zürich, Switzerland.
Jeppe H ChristensenAalborg University Hospital, Aalborg, Denmark.
Ashot M EssaianCity Clinical Hospital #31, Saint Petersburg, Russia.
Lars L ThomsenPharmacosmos A/S, Holbaek, Denmark.
Iain C MacdougallKing's College Hospital London, London, UK.
Daniel W CoyneWashington University School of Medicine St. Louis, St. Louis, MO, USA.
Aalborg University Hospital · DKCity Clinical Hospital No 31 · RUHull and East Yorkshire Hospitals NHS Trust · GBKing's College Hospital · GBNational Hospital · INPharmacosmos (Denmark) · DKSalford Royal NHS Foundation Trust · GBStadtspital Waid · CHWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIron deficiency anaemia is common in patients with chronic kidney disease, and intravenous iron is the preferred treatment for those on haemodialysis. The aim of this trial was to compare the efficacy and safety of iron isomaltoside 1000 (Monofer®) with iron sucrose (Venofer®) in haemodialysis patients.

methodsThis was an open-label, randomized, multicentre, non-inferiority trial conducted in 351 haemodialysis subjects randomized 2:1 to either iron isomaltoside 1000 (Group A) or iron sucrose (Group B). Subjects in Group A were equally divided into A1 (500 mg single bolus injection) and A2 (500 mg split dose). Group B were also treated with 500 mg split dose. The primary end point was the proportion of subjects with haemoglobin (Hb) in the target range 9.5-12.5 g/dL at 6 weeks. Secondary outcome measures included haematology parameters and safety parameters.

resultsA total of 351 subjects were enrolled. Both treatments showed similar efficacy with >82% of subjects with Hb in the target range (non-inferiority, P = 0.01). Similar results were found when comparing subgroups A1 and A2 with Group B. No statistical significant change in Hb concentration was found between any of the groups. There was a significant increase in ferritin from baseline to Weeks 1, 2 and 4 in Group A compared with Group B (Weeks 1 and 2: P < 0.001; Week 4: P = 0.002). There was a significant higher increase in reticulocyte count in Group A compared with Group B at Week 1 (P < 0.001). The frequency, type and severity of adverse events were similar.

conclusionsIron isomaltoside 1000 and iron sucrose have comparative efficacy in maintaining Hb concentrations in haemodialysis subjects and both preparations were well tolerated with a similar short-term safety profile.

Indexed as

Renal DialysisAdolescentAdultAgedAged, 80 and overAnemia, Iron-DeficiencyDisaccharidesEarly Intervention, EducationalFemaleFerric CompoundsFerric Oxide, SaccharatedFerritinsGlucaric AcidHematinicsHemoglobinsHumansDisaccharidesFerric CompoundsFerric Oxide, SaccharatedFerritinsGlucaric AcidHematinicsHemoglobinsiron isomaltoside 1000chronic kidney diseaseiron isomaltoside 1000iron treatment

Identifiers

PMID25925701
PMCPMC4550440
OpenAlexW2103992480

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.