Issue 15   |  28 Apr 2023 


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. Participant Status

Retention of participants is key to the success of the TRACK trial. Every participant counts. For the trial to succeed, we need to do everything we can to keep the participants in the trial even when they discontinued the study medication.

The run-in period is 21 days (range 14 to 30 days). Once the participant is enrolled into the trial, it is important to randomise the participant within this required timeframe. Tip: As part of the screening visit, book the participant randomisation visit for as soon as possible after the end of the 21 days period, so it will allow time to follow up the participant if needed within the 30 days window.

Withdrawn- Pre-Randomisation
All the trial procedures should be discussed with participants in the screening visit. This may help to reduce the number of participants who decide to not continue in the trial after the run-in period.

Once the participant has been randomised to the trial, there is no need to withdraw a participant. Usually when a participant asks to withdraw from the trial, they want to stop taking the study medication. In this case, the site PI should discuss with the participant their options.

Discussion points & participant options:

  Ask the participant why they want to withdraw from the trial.

  If the participant wants to stop taking the study medication, explain that they do not have to withdraw from the trial to stop taking the study medication. Ask the participant to continue with the study follow ups and let them know that all follow up visits can be also conducted remotely, via video calls, phone or telehealth.

  If the participant decides that they no longer want to be contacted for the study, ask the participant for permission to continue collecting information that does not require participant contact. It will allow us to continue collecting study events that can be ascertained from the medical records, or by contacting other health practitioners.


2. Database: Mid-Study Update #3

The TRACK database Mid-Study Update #3 is now completed. The following changes have been made: 

  Exclusion Criteria: Additional exclusion criteria: �Incapable of recognizing the nature, significance, and scope of the clinical trial or giving consent are excluded, even if they have a legal representative�. Note: This exclusion criteria needs to be completed by German sites only, all sites outside Germany need to tick 'Not applicable' to this criteria.

  Enrolment � Visit Date: Hiding or inability for site staff to answer the question �MBS and/or PBS consent obtained?�

  Study Medication Log: Addition of �Death� option if �Long-term� IMP stoppage is selected. 

Previously if the reason for stopping IMP long term was death, then sites ticked 'Other' and added 'Death' under 'Please describe'.  To assist in analysing the data at later stage, we would like sites to change their response from 'Other' to 'Death'. Please see below a screenshot from the database of the change required:


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Presentation by Professor Sunil Badve


Professor Sunil Badve presentation regarding the TRACK trial at the Nephrology Grand Rounds at the Ottawa Hospital, Canada


Recruitment and Country Updates
All figures are as of 24 April 2023



Global Recruitment Graph: Monthly Progression
Below figures are as of 24 April 2023



Global Recruitment Graph: Randomised vs Target
Below figures are as of 24 April 2023


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To remain up to date on site status, visit
Only sites with participants on run-in or randomised have been included.



Welcome to New Site


We would like to warmly welcome the new site Research St. Joseph's - Hamilton that is now activated for the TRACK trial:

Country: Canada
Site Name: Research St. Joseph's - Hamilton
Site PI: Dr. Michael Walsh
Date Site Activation: 24 February 2023

We are looking forward to seeing the first participant enrolled in your site!


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.


TRACK Feature Profile


Name: Prof Jannet Labidi
TRACK Tunisian Principal Investigator
 Tunis, Tunisia
Professor Labidi is the Head of the Nephrology Department at Military Hospital, Tunis, Tunisia. She obtained Nephrology diploma since 2000, and additional diploma in methodology, statistics and epidemiology as well as European Diploma in First Aid and Basic Cardiopulmonary Resuscitation.
She is passionate about the research in her field and is member of the research unit in the hemodialysis department, member of research laboratory LR12DN01 entitled "Hemodynamic Resuscitation and Techniques Extrarenal Purification", member of the commission responsible for developing medical standards of suitability for recruitment for the benefit of the army, with the production of a regulatory test and member of a working group whose objective is the development of a Tunisian reference system. She is also the president of the TUN-CKDD project evaluating the prevalence of chronic kidney disease in Tunisian diabetics.