Trial reportBlood2021
The contact activation inhibitor AB023 in heparin-free hemodialysis: results of a randomized phase 2 clinical trial.
Trial report in Blood, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03612856 (A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy/Potency of a Single Dose of Xisomab 3G3, Administered at the Beginning of a Regular Hemodialysis Procedure, in Patients With End-Stage Renal Disease on Chronic Hemodialysis), which is not on this map. Cited by 68 papers, 3 of them syntheses that pooled 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.
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.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy/Potency of a Single Dose of Xisomab 3G3, Administered at the Beginning of a Regular Hemodialysis Procedure, in Patients With End-Stage Renal Disease on Chronic Hemodialysis
Who cites it
68 citing papers in PubMed, 3 syntheses or guidelines pooled it, 113 citations in OpenAlex.
- Emerging trends in anticoagulation therapy: a bibliometric analysis of DOACs and endogenous coagulation pathway inhibitors.Naunyn-Schmiedeberg's archives of pharmacology · 2025Pooled it
- Factor XI as a new target for prevention of thromboembolism in cardiovascular disease: a meta-analysis of randomized controlled trials.Journal of thrombosis and thrombolysis · 2025Pooled it
- Anticoagulation for people receiving long-term haemodialysis.The Cochrane database of systematic reviews · 2024Pooled it
- Pharmacokinetics, pharmacodynamics, and safety of frunexian in healthy Chinese volunteer adults: A randomized dose-escalation phase I study.Clinical and translational science · 2024Trial
- Factor XI Inhibition for the Prevention of Catheter-Associated Thrombosis in Patients With Cancer Undergoing Central Line Placement: A Phase 2 Clinical Trial.Arteriosclerosis, thrombosis, and vascular biology · 2024Trial
- Lipopolysaccharide and Coagulation Factor XII: Biophysics of Contact Activation in Infection.Seminars in thrombosis and hemostasis · 2026Review
- Potential Role of Contact Pathway Factors in Catheter-Related Thrombosis: Emerging Evidence and Therapeutic Strategies.Biomolecules · 2026Review
- Emerging strategies in venous thromboembolism: a narrative review of pharmacological innovations.Thrombosis journal · 2026Review
- Targeting Factor XI for Safer Anticoagulation: Emerging Data and Future Directions.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2026Review
- Antibodies to mannose-binding lectin and factor XI Inhibit Shiga toxin-induced kidney injury additively in a murine model.Pediatric research · 2026Article
- Venous thromboembolism prevention and treatment with factor XI/XIa inhibitors: current status and future perspectives.Journal of thrombosis and thrombolysis · 2026Review
- Factor XI inhibitors for the prevention and treatment of venous and arterial thromboembolism.Nature reviews. Cardiology · 2025Review
- Bacterial infection and activation of the contact pathway of coagulation.Blood vessels, thrombosis & hemostasis · 2025Review
- Review
- Emerging Targets, Novel Directions, and Innovative Approaches in Thrombosis Therapy.Aging and disease · 2025Review
- Anticoagulation Management: Current Landscape and Future Trends.Journal of clinical medicine · 2025Review
- Catheter-related deep vein thrombosis: Where are we at and where are we going? Updates and ongoing unmet clinical needs.European journal of clinical investigation · 2025Review
- Factor XI inhibitors are the novel promising anticoagulants in the treatment of age related thrombotic disease.Frontiers in cardiovascular medicine · 2025Review
- A Systematic Review of Safety and Efficacy of Factor XI/XIa Inhibitors in Patients With ESKD on Hemodialysis.Kidney international reports · 2025Article
- Milvexian: An Oral, Bioavailable Factor XIa Inhibitor.Cardiology and therapy · 2024Review
8 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 4 institutions in 2 countries.
Funding
Abstract
End-stage renal disease (ESRD) patients on chronic hemodialysis have repeated blood exposure to artificial surfaces that can trigger clot formation within the hemodialysis circuit. Dialyzer clotting can lead to anemia despite erythropoietin and iron supplementation. Unfractionated heparin prevents clotting during hemodialysis, but it is not tolerated by all patients. Although heparin-free dialysis is performed, intradialytic blood entrapment can be problematic. To address this issue, we performed a randomized, double-blind, phase 2 study comparing AB023, a unique antibody that binds factor XI (FXI) and blocks its activation by activated FXII, but not by thrombin, to placebo in 24 patients with ESRD undergoing heparin-free hemodialysis. Patients were randomized to receive a single predialysis dose of AB023 (0.25 or 0.5 mg/kg) or placebo in a 2:1 ratio, and safety and preliminary efficacy were compared with placebo and observations made prior to dosing within each treatment arm. AB023 administration was not associated with impaired hemostasis or other drug-related adverse events. Occlusive events requiring hemodialysis circuit exchange were less frequent and levels of thrombin-antithrombin complexes and C-reactive protein were lower after AB023 administration compared with data collected prior to dosing. AB023 also reduced potassium and iron entrapment in the dialyzers, consistent with less blood accumulation within the dialyzers. We conclude that despite the small sample size, inhibition of contact activation-induced coagulation with AB023 was well tolerated and reduced clotting within the dialyzer. This trial was registered at www.clinicaltrials.gov as #NCT03612856.
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Identifiers
What OpenQuestion holds
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.