Issue 23 � 18 December 2024

🎇Special Message from the TRACK Chief Investigators🎇

Dear TRACK site teams,

As we approach the end of 2024, we want to express our deepest gratitude for your invaluable contributions to the trial. We are now transitioning toward closing recruitment in most countries. Thanks to your dedication and efforts, we have reached the significant milestone of enrolling 1,300 participants. A special thanks to our colleagues in Germany, Belgium, France, Nepal and some sites in Australia and India, who will continue enrolling participants until June 30, 2025.

As we move to the next phase of the trial, it is important that we focus to focus on three main points:

1.       Participant retention: Maintaining participant retention is vital to preserving the scientific integrity of the trial. Please strive to minimize withdrawals, as high withdrawal rates can undermine the study's validity. When in-person follow-ups are not feasible, consider offering alternative follow-up options.

2.       Minimise treatment discontinuation: High discontinuation rates of the study medication hinder our ability to accurately evaluate the effectiveness and risk-benefit profile of low-dose rivaroxaban. Whenever possible, minimize extended treatment interruptions. If medically appropriate, consider resuming the study medication�even after an extended pause

3.       Reporting trial outcomes: Every participant and every outcome matter. As an event-driven trial, TRACK depends on timely reporting of outcomes by sites. Regularly reviewing medical records is essential to ensure no outcomes are overlooked. If you have any uncertainties, please do not hesitate to reach out to us.

Your dedication to TRACK is essential to our mission. By working together, we can ensure the TRACK trial is completed successfully and on time, making a lasting impact on the lives of patients with kidney disease.

Merry Christmas and Happy New Year

Sunil and Martin

Overview of Recruitment and Outcomes 

🎉 Recruitment Target 🎉

A huge thank you again to everyone for contributing to our goal of 1300 by December 31^st 2024, our goal was achieved with time to spare!!!

Recruitment by Location

Total Participants Experiencing 1st Primary Event

1st Primary Event

*All figures are as of 17 Dec 2024

📢 Important Reminders: 📢

� When completing the Concomitant Medication page in the EDC, please first check what medications the participant is currently taking and then select from the pre-defined categories that match the medications being taken.  �Other� is only for medications NOT covered by the categories listed on the Concomitant Page.

� Please remember to update the Study Medication Log in the EDC for any short or long terms IMP stoppages.  Be careful to select the correct category for the reason for the stoppage and check if it is a medical event whether it should also be reported as an outcome or SAE

� When completing the SAE form, the information provided in �Main Diagnosis� should only include medical terminology and be the main diagnosis for the admission.  Please only use medical terminology as the terms will be mapped using a medical dictionary and this cannot be done if too much information is provided.  Additional information should be included in the section �Briefly describe the event�

� Please remember that �thrombosis of dialysis vascular access among participants with an AV fistula/graft� does NOT include �dialysis catheter thrombosis�

End of Recruitment � Summary

1.       ALL sites in Canada, Singapore, Taiwan, Saudi Arabia, Tunisia and Malaysia will close to enrolment in December 2024. 

2.       The majority of sites in India and Australia will close in December 2024 with a few remaining open until June 2025. 

3.       ALL sites in Belgium, Germany, France and Nepal will remain open until June 2025.

IBM Training Database Logins

For any site staff who wish to train/practice data entry for the study, please visit the TRACK Training IBM Database by logging in with any of the following updated training accounts.

Thank you for supporting the Track Trial.

To learn more please visit www.tracktrial.org

Warm regards,

The TRACK Trial team