Evidence map›Paper›PMID 34221384›Full record

ArticleClinical kidney journal2021

Real-world safety and effectiveness of sucroferric oxyhydroxide for treatment of hyperphosphataemia in dialysis patients: a prospective observational study.

Marc G Vervloet, Ioannis N Boletis, Angel L M de Francisco, Philip A Kalra, Markus Ketteler, Piergiorgio Messa, Manuela Stauss-Grabo, Anja Derlet, Sebastian Walpen, Amandine Perrin and 5 more

Open access · goldAbstract read
In one paragraph

Article in Clinical kidney journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.4field-weighted citation impact, top 18% 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

6 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Trial
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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

15 authors at 12 institutions in 9 countries.

Marc G VervloetDepartment of Nephrology and Amsterdam Cardiovascular Sciences (ACS), Amsterdam University Medical Center, Amsterdam, The Netherlands.ORCID https://orcid.org/0000-0003-4607-9415
Ioannis N BoletisDepartment of Nephrology, Laiko General Hospital, National and Kapodistrian University, Athens, Greece.
Angel L M de FranciscoNephrology Service, Hospital Universitario Marqués de Valdecilla, Santander, Spain.
Philip A KalraDepartment of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, UK.
Markus KettelerDepartment of General Internal Medicine and Nephrology, Robert-Bosch-Krankenhaus, Stuttgart, Germany.
Piergiorgio MessaDivision of Nephrology, Fondazione IRCCS Ca' Granda Milano, Università degli Studi di Milano, Milan, Italy.ORCID https://orcid.org/0000-0002-1512-559X
Manuela Stauss-GraboClinical & Epidemiological Research, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Germany.
Anja DerletClinical & Epidemiological Research, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Germany.
Sebastian WalpenDepartment of Medical Affairs, Vifor Fresenius Medical Care Renal Pharma, Glattbrugg, Switzerland.
Amandine PerrinDepartment of Medical Affairs, Vifor Fresenius Medical Care Renal Pharma, Glattbrugg, Switzerland.
Linda H FicocielloFresenius Medical Care Renal Therapies Group, Waltham, MA, USA.
Jacques RottembourgDivision of Nephrology, Dialysis and Transplantation, Assistance Publique-Hôpitaux de Paris, Pitié-Salpêtrière Hospital, Paris, France.
Christoph WannerDivision of Nephrology, University Hospital, Würzburg, Germany.
Jorge B Cannata-AndíaBone and Mineral Research Unit, Hospital Universitario Central de Asturias, Instituto de Investigación del Principado de Asturias, Universidad de Oviedo, RedinRen, Instituto de Salud Carlos III, Madrid, Spain.
Denis FouqueDepartment of Nephrology, UCBL, CarMeN, Centre Hospitalier Lyon-Sud, University of Lyon, Lyon, France.ORCID https://orcid.org/0000-0002-9707-7199
Fresenius Medical Care (Germany) · DEVifor Pharma (Switzerland) · CHFresenius Medical Care (United States) · USLaiko General Hospital of Athens · GRMarqués de Valdecilla University Hospital · ESRobert Bosch Hospital · DESalford Royal NHS Foundation Trust · GBSorbonne Université · FRUniversidad de Oviedo · ESUniversitätsklinikum Würzburg · DEUniversité Claude Bernard Lyon 1 · FRUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe iron-based phosphate binder (PB), sucroferric oxyhydroxide (SFOH), is indicated to control serum phosphorus levels in patients with chronic kidney disease on dialysis.

methodsThis non-interventional, prospective, multicentre, cohort study conducted in seven European countries evaluated the safety and effectiveness of SFOH in dialysis patients with hyperphosphataemia in routine practice. Safety outcomes included adverse drug reactions (ADRs) and changes in iron-related parameters. SFOH effectiveness was evaluated by changes-from-baseline (BL) in serum phosphorus and percentage of patients achieving in-target phosphorus levels.

resultsThe safety analysis set included 1365 patients (mean observation: 420.3 ± 239.3 days). Overall, 682 (50.0%) patients discontinued the study. Mean SFOH dose during the observation period was 1172.7 ± 539.9 mg (2.3 pills/day). Overall, 617 (45.2%) patients received concomitant PB(s) during SFOH treatment. ADRs and serious ADRs were observed for 531 (38.9%) and 26 (1.9%) patients. Most frequent ADRs were diarrhoea (194 patients, 14.2%) and discoloured faeces (128 patients, 9.4%). Diarrhoea generally occurred early during SFOH treatment and was mostly mild and transient. Small increases from BL in serum ferritin were observed (ranging from +12 to +75 µg/L). SFOH treatment was associated with serum phosphorus reductions (6.3 ± 1.6 mg/dL at BL versus 5.3 ± 1.8 mg/dL at Month 30; ΔBL: -1.0 mg/dL, P < 0.01). Percentage of patients achieving serum phosphorus ≤4.5 mg/dL increased from 12.0% at BL to 34.8% at Month 30, while the percentage achieving serum phosphorus ≤5.5 mg/dL increased from 29.9% to 63.0%.

conclusionsSFOH has a favourable safety and tolerability profile in a real-world setting, consistent with results of the Phase 3 study. Moreover, SFOH improved serum phosphorus control with a low daily pill burden.

Indexed as

chronic kidney diseaseend-stage kidney diseasehaemodialysisperitoneal dialysisphosphate binder

Identifiers

PMID34221384
PMCPMC8243278
OpenAlexW3127716455

What OpenQuestion holds

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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.