Evidence map›Paper›PMID 33302891›Full record

Observational studyBMC nephrology2020

NIMO-CKD-UK: a real-world, observational study of iron isomaltoside in patients with iron deficiency anaemia and chronic kidney disease.

Philip A Kalra, Sunil Bhandari, Michael Spyridon, Rachel Davison, Sarah Lawman, Ashraf Mikhail, David Reaich, Nick Pritchard, Kieran McCafferty, Jason Moore

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in BMC nephrology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02546154 (A Non-interventional Study of the Time to Relapse of Iron Deficiency Anaemia After Standard Treatment With the Intravenous Iron Monofer®), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.4field-weighted citation impact, top 16% 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.

NCT02546154 completednot on this map

A Non-interventional Study of the Time to Relapse of Iron Deficiency Anaemia After Standard Treatment With the Intravenous Iron Monofer® (10% Iron Isomaltoside 1000)

TypeobservationalSponsorPharmacosmos UK LtdRan2016 to 2018Enrolled359ConditionsIron Deficiency AnaemiaArms10% Iron Isomaltoside 1000
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 17 citations in OpenAlex.

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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

10 authors at 9 institutions in 1 country.

Philip A KalraSalford Royal NHS Foundation Trust, Salford, UK. philip.kalra@srft.nhs.uk.
Sunil BhandariHull University Teaching Hospitals NHS Trust, Hull, UK.
Michael SpyridonPharmacosmos UK, Reading, UK.
Rachel DavisonSunderland Royal Hospital, Sunderland, UK.
Sarah LawmanRoyal Sussex County Hospital, Brighton, UK.
Ashraf MikhailMorriston Hospital, Swansea, UK.
David ReaichThe James Cook University Hospital, Middlesbrough, UK.
Nick PritchardAddenbrooke's University Hospital, Cambridge, UK.
Kieran McCaffertyRoyal London University Hospital, London, UK.
Jason MooreRoyal Devon and Exeter University Hospital, Exeter, UK.
Addenbrooke's Hospital · GBJames Cook University Hospital · GBMorriston Hospital · GBPrincess Royal University Hospital · GBRoyal Devon and Exeter Hospital · GBRoyal Sussex County Hospital · GBSalford Royal NHS Foundation Trust · GBSunderland Royal Hospital · GBUniversity of Hull · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntravenous iron is often used to treat iron deficiency anaemia in non-dialysis chronic kidney disease (ND-CKD), but the optimal dosing regimen remains unclear. We evaluated the impact of high- versus low-dose intravenous iron isomaltoside on the probability of retreatment with intravenous iron in iron-deficient ND-CKD patients.

methodsThis real-world, prospective, observational study collected data from 256 ND-CKD patients treated for anaemia in the UK. Following an initial course of iron isomaltoside, patients were followed for ≥12 months. Iron dose and the need for retreatment were determined at the investigators' discretion. The primary study outcome was the need for retreatment at 52 weeks compared between patients who received >1000 mg of iron during Course 1 and those who received ≤1000 mg. Safety was evaluated through adverse drug reactions.

resultsThe probability of retreatment at Week 52 was significantly lower in the >1000 mg iron group (n = 58) versus the ≤1000 mg group (n = 198); hazard ratio (95% confidence interval [CI]): 0.46 (0.20, 0.91); p = 0.012. Mean (95% CI) haemoglobin increased by 6.58 (4.94, 8.21) g/L in the ≤1000 mg group and by 10.59 (7.52, 13.66) g/L in the >1000 mg group (p = 0.024). Changes in other blood and iron parameters were not significantly different between the two groups. Administering >1000 mg of iron isomaltoside saved 8.6 appointments per 100 patients compared to ≤1000 mg. No serious adverse drug reactions were reported. Of the patients who received ≤1000 mg of iron in this study, 82.3% were eligible for a dose >1000 mg.

conclusionsThe >1000 mg iron isomaltoside regimen reduced the probability of retreatment, achieved a greater haemoglobin response irrespective of erythropoiesis-stimulating agent treatment, and reduced the total number of appointments required, compared to the ≤1000 mg regimen. Many of the patients who received ≤1000 mg of iron were eligible for >1000 mg, indicating that there was considerable underdosing in this study.

trial registrationClinicalTrials.gov NCT02546154 , 10 September 2015.

Indexed as

Administration, IntravenousAnemia, Iron-DeficiencyDisaccharidesFatigueFemaleFerric CompoundsHematinicsHemoglobinsHumansMaleProportional Hazards ModelsProspective StudiesRenal Insufficiency, ChronicRetreatmentSeverity of Illness IndexTreatment OutcomeDisaccharidesFerric CompoundsHematinicsHemoglobinsiron isomaltoside 1000AnaemiaChronic kidney diseaseFerric derisomaltoseIntravenous ironIron deficiencyIron isomaltoside 1000Non-dialysis dependentObservationalReal-world

Identifiers

PMID33302891
PMCPMC7726614
OpenAlexW3112096880

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.