Treatment of cardiovascular disease with low dose Rivaroxaban in Advanced Chronic Kidney disease (The TRACK trial)

• Applicant: Professor Dr. Jan Menne
• Subject Area: Nephrology
• Term: since 2025
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 506165771

There is a substantial burden of cardiovascular disease in patients with advanced chronic kidney disease (estimated glomerular filtration rate [eGFR] <30 ml/min.). A cardiac cause accounts for 49% of all deaths in these patients and even 58% in patients requiring dialysis. In 2013, chronic kidney disease was associated with 4% of all deaths or 2.2 million deaths worldwide, of which more than half (1.2 million) were attributed to CV causes. Overall, 5.9% of the population of Germany have chronic kidney disease stage 3-5 (eGFR <60 ml/min/1.73 m2); and approximately 94,000 people require kidney replacement treatment. It is expected that the prevalence of advanced kidney disease will further increase in the next years. The excess cardiovascular morbidity and mortality in chronic kidney disease is likely to be partly due to the high prevalence of traditional factors, such as hypertension, dyslipidemia, and diabetes. In addition, several ‘non-traditional’ risk factors, such as hypercoagulability and chronic inflammation, may also contribute to the elevated cardiovascular risk. Antithrombotic therapy with antiplatelet agents or anticoagulants is a core intervention in the prevention of cardiovascular events. Since nearly 55% and 90% of CV trials evaluating antiplatelet and anticoagulant agents, respectively, excluded patients with advanced chronic kidney disease the available data are limited in this patient population. The aim of the TRACK trial is to test the hypothesis that, compared to placebo, low dose rivaroxaban (2.5 mg twice daily) significantly reduces the risk of major cardiovascular events in people at advanced CKD and elevated CV risk; and has an acceptable bleeding risk. The TRACK Trial is an investigator-initiated, international, collaborative, double-blind, event-driven, randomized controlled trial (RCT) that will assess the effect of low dose rivaroxaban versus placebo on the risk of major cardiovascular events in people with advanced chronic kidney disease (eGFR <30 ml/min.) including patients requiring dialysis. The aim is to randomize 1886 patients until middle/end of 2024. The study will finish most likely in 2026 when 515 patients had a primary endpoint (cardiovascular death, myocardial infarction, stroke or peripheral vascular event). We plan to randomize 200 patients (>10% of the total cohort) using an established referral network of nephrology units in the region.

• DFG Programme: Clinical Trials