TRACK Study Update from The George Institute for Global Health

Issue 20 � 29^th Feb 2024

Study Overview

The TRACK trial will evaluate whether a small dose of rivaroxaban, a blood-thinning medication, would reduce cardiovascular death or major cardiovascular events in patients with advanced stages of chronic kidney disease.

Important Updates & Reminders

1. Words from Chief Investigator Prof. Sunil Badve

2. Recruitment

The TRACK Trial passed 1000 patient randomisations shortly after the new year, reaching 1033 on the 26^th of February. It is now the largest trial to date in cardiovascular disease (CVD) and chronic kidney disease (CKD) populations. Another important milestone was passed recently, with our median follow-up duration now exceeding 365 days, making TRACK the longest follow-up trial for this cohort!

Despite these impressive milestones, we are still behind our projected recruitment rate by a significant margin. The success of the trial is dependent on our ability to recruit and retain patients. In order to reach our total recruitment target of 1886 by December 2024, all countries and sites must continue to make a significant contribution to participant numbers.

Recruitment Strategies

The nature of the patients eligible for the TRACK trial means that they are regular visitors of clinics, hospitals and dialysis units. Periodic review of patient lists from these locations is a good strategy for recruiting new participants.

� National Leads play a crucial role in setting the tone for regional sites, providing guidance, encouragement and advice.

� Investigator Meetings are an excellent opportunity to discuss recruitment strategies specific to the region and gain insights from high recruiting sites.

� Adress concerns patients may have regarding bleeding risk by communicating the low rates of bleeding seen in the TRACK trial and the stringent safety measures.  

3. Bleeding Risk

A reminder that in the most recent DSMB report from December 2023 the bleeding rate for major bleeds was reported as 3.4 per 100 person years (py).  This is significantly lower than what is reported in our Patient Information Sheet (10.0/100py) and lower than rates seen in both dialysis and non-dialysis patients in a recent comparison of similar trials.  The reason is likely two-fold:

1. The TRACK trial is using a low dose a Rivaroxaban, well below the therapeutic dose.

2. The TRACK trial eligibility criteria carefully excludes any high-risk patients.

This low bleeding rate is very encouraging and should provide reassurance to patients enrolled in the TRACK trial.  If you have any particular concerns with regards to bleeding, please do not hesitate to reach out to our coordinating investigator Prof. Sunil Badve directly.

We encourage staff at sites to communicate to patients that the Patient Information and Consent Form risk rates are not reflective of those seen in our therapeutic dose. The regular DSMB screening and stringent safety measures outlined in our study protocol are additional points of reassurance.

4. Outcomes Vs SAEs

A recent review of Serious Adverse Event (SAE) listings has identified some instances of misreporting.

� Peripheral Artery Disease (PAD) events like amputations are primary outcomes and should be reported as such, not as SAEs.

� Potential cardiovascular deaths, stokes and non-fatal myocardial infarctions are all primary outcomes.

We ask staff to carefully consider, when reporting an SAE, if the event could potentially be an outcome. If you are unsure if an event is an SAE or an outcome, please do not hesitate to reach out to your CRA for confirmation or refer to Appendix 1 of the protocol which provides a comprehensive overview of outcome definitions.

Capturing all outcome events under the correct categorisation is crucial, as underreporting can impact statistical power and trial integrity.

Important Reminders:

� Good Clinical Practice�Certifications must be within 3 years for all staff. Please requalify as soon as possible if certifications are outside this period.

� High rates of Withdrawal Post Randomisation and Lost to Follow-up participants have the potential to negatively impact study power.

� High rates of IMP Discontinuation may also result in loss of study power. This has been highlighted by the DSMB in Dec 2023. For IMP discontinuation due to participant request (not due to adverse event or bleeding), please keep communication open for participants to consider resuming IMP.

Recruitment and Country Updates

All figures are as of 26 Feb 2024

Global Recruitment Graph: Monthly Progression

Below figures are as of 26 Feb 2024

Global Recruitment Graph: Randomised vs Target

Below figures are as of 26 Feb 2024

January-February Site Recruitment 

Blue Sites have met or exceeded target. Yellow sites are top 2 recruiters for Jan 01-Feb 26 period.

New Sites

We would like to warmly welcome the below new sites that are now activated for the TRACK trial:

Country: France
Site Name: 25004 CHU de Mulhouse
Site PI: Dr Isabelle Kazes
Date Site Activation: 26 Feb 2024

Country: France
Site Name: 25011 CHU de Reims
Site PI: Dr Fran�ois Chantrel
Date Site Activation: 20 Feb 2024

We are looking forward to seeing the first participants enrolled at your sites!

January-February Regional Recruitment 

*Percentage of Recruitment target met by Feb 26 2024. Note: Taiwan no longer recruiting.

TRACK Feature Profile

Name:�Dr. Sandeep Garg
Position/Role: Principal Investigator
Location: Nutema Hospital, Meerut India
About: Dr Garg is a Director, Consultant Nephrologist, Dialysis Expert and Renal transplant Physician at NUTEMA Hospital Meerut. Dr Garg has over 20 years of experience as a Consultant Nephrologist and has a special interest in critical care nephrology, dialysis and kidney transplants. Has run successful kidney transplant programs for last 15 years in Meerut and the Indian National Central Region, with more than 300 renal transplants to his credit. Dr Garg has experience in a wide range of transplants, including paediatric and ABO or HLA Incompatible transplants.

Site 35621 Nutema Hospital has randomised 28 patients since its activation on the 24th of August 2023. They enrolled their first participant only 4 days after site activation and have continued to perform excellently in the subsequent months. In today�s Newsletter, Nutema is currently the joint leader of recruitment in 2024 for India, with 4 randomisations and across the January-February period. Our thanks go out to Dr Garg and the Nutema site staff for their phenomenal efforts.       

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