Evidence map›Paper›PMID 32049331›Full record

Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2021

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.

Sunil Bhandari, Philip A Kalra, Mario Berkowitz, Diogo Belo, Lars L Thomsen, Myles Wolf

Registry-linked trialOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2021. 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 42 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 4 pooled it
9.0field-weighted citation impact, top 1% 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

42 citing papers in PubMed, 4 syntheses or guidelines pooled it, 96 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

6 authors at 4 institutions in 3 countries.

Sunil BhandariDepartment of Renal Medicine, Hull University Teaching Hospitals NHS Trust, Kingston upon Hull, UK.
Philip A KalraDepartment of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, UK.
Mario BerkowitzLeon Medical Research, Miami, FL, USA.
Diogo BeloCalifornia Institute of Renal Research, Chula Vista, CA, USA.
Lars L ThomsenDepartment of Clinical and Non-clinical Research, Pharmacosmos A/S, Holbaek, Denmark.
Myles WolfDivision of Nephrology, Department of Medicine, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Clinical Research Institute · USPharmacosmos (Denmark) · DKPrecision Research Institute · USSalford Royal NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe optimal intravenous (IV) iron would allow safe correction of iron deficiency at a single infusion over a short time. The FERWON-NEPHRO trial evaluated the safety and efficacy of iron isomaltoside 1000/ferric derisomaltose (IIM) in patients with non-dialysis-dependent chronic kidney disease and iron deficiency anaemia.

methodsIn this randomized, open-label and multi-centre trial conducted in the USA, patients were randomized 2:1 to a single dose of 1000 mg IIM or iron sucrose (IS) administered as 200 mg IV injections up to five times within a 2-week period. The co-primary endpoints were serious or severe hypersensitivity reactions and change in haemoglobin (Hb) from baseline to Week 8. Secondary endpoints included incidence of composite cardiovascular adverse events (AEs).

resultsA total of 1538 patients were enrolled (mean estimated glomerular filtration rate 35.5 mL/min/1.73 m2). The co-primary safety objective was met based on no significant difference in the incidence of serious or severe hypersensitivity reactions in the IIM and IS groups [0.3% versus 0%; risk difference: 0.29% (95% confidence interval: -0.19; 0.77; P > 0.05)]. Incidence of composite cardiovascular AEs was significantly lower in the IIM versus IS group (4.1% versus 6.9%; P = 0.025). Compared with IS, IIM led to a more pronounced increase in Hb during the first 4 weeks (P ≤ 0.021), and change in Hb to Week 8 showed non-inferiority, confirming that the co-primary efficacy objective was met.

conclusionsCompared with multiple doses of IS, a single dose of IIM induced a non-inferior 8-week haematological response, comparably low rates of hypersensitivity reactions, and a significantly lower incidence of composite cardiovascular AEs.

Indexed as

Administration, IntravenousAdultAgedAged, 80 and overAnemia, Iron-DeficiencyDisaccharidesFemaleFerric CompoundsFerric Oxide, SaccharatedHematinicsHemoglobinsHumansInjections, IntravenousMaleMiddle AgedProspective StudiesDisaccharidesFerric CompoundsFerric Oxide, SaccharatedHematinicsHemoglobinsiron isomaltoside 1000ferric derisomaltoseiron deficiency anaemiairon isomaltoside 1000iron treatment

Identifiers

PMID32049331
PMCPMC7771981
OpenAlexW3005591251

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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.