Evidence map›Paper›PMID 38365952›Full record

Trial reportNature medicine2024

Anticoagulation with osocimab in patients with kidney failure undergoing hemodialysis: a randomized phase 2 trial.

Jeffrey I Weitz, László B Tankó, Jürgen Floege, Keith A A Fox, Deepak L Bhatt, Ravi Thadhani, James Hung, Ákos F Pap, Dagmar Kubitza, Wolfgang C Winkelmayer and 1 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Nature medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04523220 (A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study to Assess the Safety and Tolerability of Monthly Subcutaneous Administrations of a Low and High Dose Cohort of Osocimab to ESRD Patients on Regular Hemodialysis), which is not on this map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
18.8field-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.

NCT04523220 phase2completednot on this map

A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study to Assess the Safety and Tolerability of Monthly Subcutaneous Administrations of a Low and High Dose Cohort of Osocimab to ESRD Patients on Regular Hemodialysis

TypeinterventionalSponsorBayerRan2020 to 2022Enrolled704ConditionsEnd-stage Renal Disease, Prevention of Thromboembolic Events, Hemodialysis, HemodiafiltrationArmsBAY1213790 (Osocimab), Placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

  1. Management of antithrombotic therapies in kidney transplantation candidates and recipients: an ERBP clinical practice document by the DESCaRTES Working Group of ERA and the EKITA Committee of ESOT.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026
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  6. Targeting Factor XI for Safer Anticoagulation: Emerging Data and Future Directions.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2026
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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

11 authors at 8 institutions in 5 countries.

Jeffrey I WeitzThrombosis and Atherosclerosis Research Institute and McMaster University, Hamilton, Ontario, Canada. weitzj@taari.ca.ORCID 0000-0002-1092-7550
László B TankóClinical Development and Operations, Bayer Consumer Care AG, Basel, Switzerland.
Jürgen FloegeDivision of Nephrology and Rheumatology, RWTH Aachen University Hospital, Aachen, Germany.
Keith A A FoxCentre for Cardiovascular Sciences, University of Edinburgh, Edinburgh, UK.ORCID 0000-0002-0140-2752
Deepak L BhattMount Sinai Heart, Icahn School of Medicine at Mount Sinai Health System, New York, NY, USA.ORCID 0000-0002-1278-6245
Ravi ThadhaniEmory University School of Medicine, Atlanta, GA, USA.
James HungClinical Development and Operations, Bayer SA, São Paulo, Brazil.
Ákos F PapClinical Data Sciences and Analytics, Bayer AG, Wuppertal, Germany.ORCID 0000-0002-2161-3151
Dagmar KubitzaClinical Pharmacology, Bayer AG, Wuppertal, Germany.
Wolfgang C WinkelmayerSection of Nephrology, Baylor College of Medicine, Houston, TX, USA.
CONVERT Investigators
Bayer (Germany) · DEBayer (Switzerland) · CHBaylor College of Medicine · USEmory University · USMount Sinai Health System · USThrombosis and Atherosclerosis Research Institute · CAUniversitätsklinikum Aachen · DEUniversity of Edinburgh · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Individuals with kidney failure undergoing hemodialysis are at elevated risk for thromboembolic events. Factor (F) XI, which is in the intrinsic pathway of coagulation, is emerging as an attractive target for new anticoagulants that may be safer than existing agents. Osocimab-an inhibitory FXIa antibody-is a potential treatment option for such patients. We conducted a phase 2b, double-blind, placebo-controlled trial, in which 704 participants (448 male, 256 female) with kidney failure undergoing hemodialysis were randomized to receive lower- or higher-dose osocimab or placebo. In total, 686 participants (436 male, 250 female) received treatment for ≤18 months (planned minimal treatment period of 6 months). The co-primary outcomes were clinically relevant bleeding (a composite of major and clinically relevant nonmajor bleeding) and a composite of the incidence of moderate, severe or serious adverse events. Clinically relevant bleeding occurred in 16/232 (6.9%) and 11/224 (4.9%) participants who received lower- and higher-dose osocimab, respectively, and in 18/230 participants (7.8%) who received a placebo. For the composite adverse event endpoint, incidences were 51%, 47% and 43% in the lower-dose osocimab, higher-dose osocimab and placebo groups, respectively. These results suggest that osocimab is associated with a low risk of bleeding and is generally well tolerated in this population; findings that require confirmation in larger trials. ClinicalTrials.gov identifier, NCT04523220 .

Indexed as

Antibodies, Monoclonal, HumanizedBlood CoagulationRenal InsufficiencyAnticoagulantsDouble-Blind MethodFemaleHemorrhageHumansMaleRenal DialysisAntibodies, Monoclonal, HumanizedAnticoagulantsosocimab

Identifiers

PMID38365952
PMCPMC10878964
OpenAlexW4391883120

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.