A Phase 3 interventional study of Rivaroxaban in Chronic Hemodialysis Patients, sponsored by University Hospital, Tours. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by University Hospital, Tours · Phase 3, Interventional, and Treatment
Atrial fibrillation is the most frequent cardiac rhythm disorder and its prognosis is essentially marked by the risk of embolic events. Its treatment is based on long-term oral anticoagulant therapy according to the risk of embolic events assessed by risk scores such as the CHA2DS2-Vasc score, but this prescription is associated with a risk of hemorrhagic events that must be taken into consideration when deciding on the treatment for a given patient. There are two categories of validated oral anticoagulant treatments for the prevention of embolic events in atrial fibrillation: antivitamin K agents, which have long been the reference treatment but are restrictive and difficult to use because of a narrow therapeutic window, and direct oral anticoagulants, which are now the first-line treatment but have not been evaluated in phase II and III studies in patients with severe renal failure. End-stage renal disease (clearance \<15 mL/min/1.73m2), particularly at the dialysis stage, is a risk factor for cardiovascular disease in its own right, and a significant number of patients develop atrial fibrillation. Given the co-morbidities associated with renal failure, in particular hypertension, patients with renal failure undergoing dialysis and suffering from atrial fibrillation are generally at a higher risk of embolism than patients without renal failure, but also at a higher risk of bleeding. Thus, if the indication for prescribing oral anticoagulant therapy is clear in this population, the associated bleeding complications are also more frequent and more serious in these patients who have regular vascular accesses in the context of hemodialysis. There is thus a real need for reliable therapeutic alternatives with a better benefit/risk ratio than antivitamins K.
Translated with www.DeepL.com/Translator (free version)
Chronic dialysis patients are a special population because the constraints linked to their disease (3 dialyses per week) make them a captive population that nephrologists know perfectly well. If the identification of the subjects to be included does not pose any problem, it is more their adherence to the project which is likely to be more difficult because it implies additional constraints in these patients with potentially many comorbidities.
This proof-of-concept study will identify the dose of rivaroxaban with the best pharmacokinetic/ pharmacodynamic profile in chronic hemodialysis patients. It will then be possible to envisage a larger study of the type of a national Hospital Clinical Research Program (PHRC) in order to evaluate the dose of rivaroxaban chosen in hemodialysis patients with atrial fibrillation with an indication for oral anticoagulation on the basis of morbidity-mortality criteria in comparison with treatment with antivitamins K that is well conducted.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 10 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.
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Exclusion Criteria:
Rivaroxaban 5 mg daily, administered orally, during 3 consecutive days. After a wash-out period of 4 days, Rivaroxaban 10 mg daily, administered orally, during 3 consecutive days. After a wash-out period of 4 days, Rivaroxaban 15 mg daily, administered orally, during 3 consecutive days.
Drug: Rivaroxaban
Experimental group Each patient will receive successively over 3 distinct periods the 3 doses of rivaroxaban to be evaluated, i.e., 5 mg, 10 mg, and 15 mg as a single daily dose (once daily over 3 days for each dose).
Pharmacodynamics of 3 reduced dose regimen of rivaroxaban (5 mg/day, 10 mg/day, or 15 mg/day)
Plasma anti-Xa activity assessment (international unit per milliliter, IU/mL) on serial blood sampling at specified time points
Time frame: 1 month
Pharmacokinetics of 3 reduced dose regimen of rivaroxaban (5 mg/day, 10 mg/day, or 15 mg/day)
Direct measurement of Rivaroxaban plasma level (nanogram per milliliter, ng/mL) on serial blood sampling at specified time points
Time frame: 1 month
Hemorrhagic risk assessment of 3 reduced dose regimen of rivaroxaban (5 mg/day, 10 mg/day, or 15 mg/day)
Every bleeding event will be reported and classified according to the BARC classification
Time frame: 1 month
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University Hospital, Tours