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Issue 28 – May 2026

On behalf of the TRACK Chief Principal Investigators Professor Sunil Badve and Professor Martin Gallagher, we would like to sincerely thank all 90 participating sites across 12 countries for your commitment, collaboration and valuable contributions throughout the TRACK study. Your support in study delivery, participant follow-up and close-out activities has been essential for the success of the trial. We are very grateful for your continued partnership and dedication.

We would also like to extend our sincere thanks to the wider teams who have supported TRACK over the course of the study, including our Operations teams:

Global Project Team (GPT) - Australia

Aline Ramos Da Cruz, Namrata Nath Kumar, Krupa Philip, Jenny Landrigan, Shalomi Weerawardena, Michelle Kim, Ewelina Czajkowska, Colette Beck, Shreya Jyo, Wai Poon

And our Regional Coordinating Centres (RCCs):

🤝 The George Institute for Global Health - India ✨

Aishwarya Nair, Gunjan Tripathi

Rajendra Kumar

🤝 Eshmoun Clinical Research - Tunisia ✨

Ghofrane Ben Messaoud

Farah Zribi

🤝 Centre Hospitalier Régional Universitaire de Nancy - France ✨

Julie Lecomte

Taous Zamoun

Marie-Lauren Antoine

🤝 King Abdullah International Medical Research Center (KAIMRC) - Saudi Arabia ✨

                                                                            Khizra Sultana                                                                           

🤝Emerald Clinical - East Asia ✨

Your collaboration, professionalism and support have played an important role in the delivery of the trial.

😆 Key Milestones 👍

As TRACK progresses toward closure, we have reached several important milestones across the study. Below is a summary timeline highlighting key achievements in the TRACK journey.

2019	Ethics approval obtained in Australia.

2020	First 3 sites activated in Australia.

2021	First participant enrolled in Australia - January. Sites activated in India, Malaysia, Singapore, and Taiwan.

2022	Site activated in Tunisia and Saudi Arabia.

2023	Sites activated in France and Belgium.

2024	TRACK enrolled 1,300 participants globally. Last site is activated in Nepal.

2025	1,463 participants randomised globally. DSMB recommended early termination of the trial in August. Last Participant Last Visit (LPLV) performed on 29 October in Tunisia.

2026	Database locked on 28 January. All 90 activated sites to be closed by May. Final statistical analysis underway. Results to be presented in the 63rd ERA Congress in Glasgow, Scotland in June.

📒Site Close Out Status📒

Close out visits have been performed at 99% of our sites. Monitors are closely following up on completion of outstanding action items from the visit to confirm site closure.
Sites are now closed in Germany, Singapore and Taiwan. The cooperation and hard work contributed by you and your study team has enabled us to successfully complete closeout activities at your site.
As of 1 May 2026, 88 COVs complete and 33 sites are closed. A Country-level status summary is provided below:

The deadline to close all sites is 20 May 2026. We appreciate your continued support in completing all outstanding action items from the close‑out visit in a timely manner.

📢 Updates and Final Reminders 📢

IRB/IEC Notification

A final report must be made to the IRB/IEC to notify them of the study closure, including final status at your site and any SAEs that have not been reported previously. Please provide a copy of the IRB/IEC submission and acknowledgement letter for our files.

Retention of Documentation

All project files, patient study records and source documents must be archived for 15 years from the completion of the trial. Please ensure that archiving activities are completed as per ICH-GCP guidelines.

Outstanding invoices

Please ensure that any outstanding invoices including participant fees, pharmacy fees and close-out fees, are submitted for payment as a priority to support timely finalisation of study close-out activities at your site.

Database Zelta Access

As part of the close out activities TRACK database on Zelta was fully closed on 30 April 2026 and all users’ accesses were revoked.

Participant Treatment Allocation Arm - Unblinding Information

Sites will receive via email a list containing the treatment allocation arm for all randomised participants at your site.

The list includes each participant’s study ID and their allocated treatment arm.

Sites must archive the participant treatment allocation arm list in the Investigator Site File (ISF), either electronically or in paper format, in accordance with local site practices.

📄Publications Updates📄

We are pleased to share the following publication updates from the TRACK study:

· Statistical Analysis Plan for the Treatment of Cardiovascular disease with low dose Rivaroxaban in Advanced CKD (TRACK) trial. MedRxiv. November 27, 2025. doi: https://doi.org/10.1101/2025.11.25.25340065

· Methods Article for a Study Protocol: Study Design and Baseline Characteristics of the Treatment of Cardiovascular Disease with Low Dose Rivaroxaban in Advanced Chronic Kidney Disease (TRACK) Trial - Am J Nephrol. 2026 Feb 9:1-11. doi: 10.1159/000550796

· TRACK manuscript- under review

✨ Thank You 👏

As TRACK moves through the final phase of study close-out, we would like to once again thank you for your continued collaboration, support and commitment. Your contribution has been essential throughout the study and remains greatly valued as we work together to complete the remaining close-out activities.
This will be the final newsletter circulated to sites for the TRACK study. On behalf of the TRACK Study Team, thank you for your partnership and support over the course of the trial. We sincerely appreciate all that has been achieved together and would like to extend our best wishes to all teams as we conclude this final stage of the study.

TRACK

Thank you for supporting the Track Trial.

To learn more please visit www.tracktrial.org

Warm regards,

The TRACK Trial team

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