Trial reportClinical pharmacokinetics2017
Effect of Age and Renal Function on Idarucizumab Pharmacokinetics and Idarucizumab-Mediated Reversal of Dabigatran Anticoagulant Activity in a Randomized, Double-Blind, Crossover Phase Ib Study.
Trial report in Clinical pharmacokinetics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01955720 (Randomised, Double-blind, Placebo-controlled, Two-way Cross-over Phase Ib Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655075 and to Establish the Efficacy of BI 655075 in Reversal of Dabigatran Anticoagulant Activity in Volunteers), which is not on this map. Cited by 25 papers, 2 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.
Randomised, Double-blind, Placebo-controlled, Two-way Cross-over Phase Ib Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655075 and to Establish the Efficacy of BI 655075 in Reversal of Dabigatran Anticoagulant Activity in Volunteers
Who cites it
25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 86 citations in OpenAlex.
- 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 · 2026Guideline
- [S1 guideline - Austrian consensus for anticoagulation in the context of atrial fibrillation ablation].Wiener klinische Wochenschrift · 2018Guideline
- Pharmacokinetics of idarucizumab and its target dabigatran in patients requiring urgent reversal of the anticoagulant effect of dabigatran.Journal of thrombosis and haemostasis : JTH · 2019Trial
- Anticoagulant Effects of Dabigatran in Paediatric Patients Compared with Adults: Combined Data from Three Paediatric Clinical Trials.Thrombosis and haemostasis · 2018Trial
- From empirical hemostasis to precision reversal: clinical challenges, technological innovations, and individualized strategies in anticoagulant-associated bleeding.Frontiers in cardiovascular medicine · 2026Review
- Reversal and resumption of anticoagulants in patients with anticoagulant-associated intracerebral hemorrhage.European journal of medical research · 2024Review
- Anticoagulant Effects of Dabigatran on Coagulation Laboratory Parameters in Pediatric Patients: Combined Data from Five Pediatric Clinical Trials.Thrombosis and haemostasis · 2022Article
- Dabigatran Level Before Reversal Can Predict Hemostatic Effectiveness of Idarucizumab in a Real-World Setting.Frontiers in medicine · 2020Article
- Consensus Report on Patient Blood Management in Cardiac Surgery by Turkish Society of Cardiovascular Surgery (TSCVS), Turkish Society of Cardiology (TSC), and Society of Cardio-Vascular-Thoracic Anaesthesia and Intensive Care (SCTAIC).Turk gogus kalp damar cerrahisi dergisi · 2019Article
- A new era for migraine: Pharmacokinetic and pharmacodynamic insights into monoclonal antibodies with a focus on galcanezumab, an anti-CGRP antibody.Cephalalgia : an international journal of headache · 2019Review
- Life-threatening bleeding due to persistent dabigatran effect in a patient with sepsis despite idarucizumab therapy and haemodialysis.BMJ case reports · 2019Article
- Novel reversal agents and laboratory evaluation for direct-acting oral anticoagulants (DOAC): An update.Indian journal of anaesthesia · 2019Review
- Hemorrhagic stroke complicated by cerebral venous sinus thrombosis with idarucizumab.Neurology. Clinical practice · 2019Article
- The Renal Elimination Pathways of the Dabigatran Reversal Agent Idarucizumab and its Impact on Dabigatran Elimination.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis · 2018Article
- Chronic kidney disease and arrhythmias: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference.European heart journal · 2018Article
- Reversal agents for non-vitamin K antagonist oral anticoagulants.Nature reviews. Cardiology · 2018Review
- Pharmacological reversal of the direct oral anticoagulants-A comprehensive review of the literature.Research and practice in thrombosis and haemostasis · 2018Review
- Rationale and design of a phase III safety trial of idarucizumab in children receiving dabigatran etexilate for venous thromboembolism.Research and practice in thrombosis and haemostasis · 2018Article
- Evidence for Idarucizumab (Praxbind) in the Reversal Of the Direct Thrombin Inhibitor Dabigatran: Review Following the RE-VERSE AD Full Cohort Analysis.P & T : a peer-reviewed journal for formulary management · 2017Article
- The Use of Idarucizumab for Dabigatran Reversal in Clinical Practice: A Case Series.P & T : a peer-reviewed journal for formulary management · 2017Article
Corrections and comments
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Authors and funding
12 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesIdarucizumab is an antibody fragment that specifically reverses dabigatran-mediated anticoagulation. Safety, pharmacokinetics and pharmacodynamics of idarucizumab were investigated in dabigatran-treated, middle-aged, elderly and renally impaired volunteers with characteristics similar to patients receiving anticoagulant therapy.
methodsIn this randomized, double-blind, crossover study, 46 subjects (12 middle-aged, 45-64 years; 16 elderly, 65-80 years; and 18 with mild or moderate renal impairment) received dabigatran etexilate (DE; 220 or 150 mg twice daily) for 4 days. Idarucizumab doses of 1, 2.5 and 5 g or 2 × 2.5 g 1 h apart, or placebo, were administered as a rapid (5 min) infusion ~2 h after DE at steady state.
resultsDabigatran-prolonged diluted thrombin time, ecarin clotting time and activated partial thromboplastin time were reversed to baseline immediately after idarucizumab infusion in all groups. Reversal was sustained with doses ≥2.5 g. Idarucizumab was well tolerated under all conditions. No impact of age on idarucizumab pharmacokinetics was observed; however, subjects with mild or moderate renal impairment demonstrated increased exposure (up to 84 %), decreased clearance and prolonged (by up to 49 %) initial half-life of idarucizumab compared with healthy middle-aged subjects.
conclusionsImpaired renal function was associated with increased exposure and decreased clearance of idarucizumab. Idarucizumab resulted in immediate, complete and sustained reversal of dabigatran anticoagulant activity, and was safe and well tolerated in middle-aged, elderly and renally impaired volunteers. The results support the clinical use of a 5 g dose of idarucizumab. CLINICAL
trial registrationhttp://www.clinicaltrials.gov . Unique identifier: NCT01955720.
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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.