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Chronic Kidney DiseasesPhase 3TRACKNCT03969953

Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease

A Phase 3 study testing Rivaroxaban 2.5 Mg Oral Tablet in people with Chronic Kidney Diseases and Dialysis-dependent Kidney Failure, run by The George Institute at 88 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The TRACK trial is an investigator-initiated, multicentre, prospective, randomised, quadruple-blind (participant, healthcare provider, data collector, outcomes assessor), placebo-controlled trial. TRACK is a global trial and will be conducted in renal units that provide comprehensive CKD care. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rivaroxaban 2.5 Mg Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,753 participants
Where
88 sitesin 12 countries
Study dates
18 Jan 2021to 30 Oct 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • People able to provide informed consent who meet all of the following inclusion criteria:
  • Age ≥18 years,
  • Kidney Failure on haemodialysis or peritoneal dialysis, or CKD stage 4 or 5 (eGFR ≤29 mL/min/1.73 m2) not receiving renal replacement therapy,
  • Elevated cardiovascular risk, defined by at least one of the following:
  • History of Coronary Artery Disease (CAD) or PAD or non-haemorrhagic non-lacunar stroke, or
  • Diabetes mellitus, or
  • Age ≥65 years.

Who cannot join

  • Potential participants must have none of the following exclusion criteria at the time of study enrolment:
  • Mechanical/prosthetic heart valve (does not include bioprosthetic valves that do not require therapeutic anticoagulation),
  • Indication for, or contraindication to, anticoagulant therapy,
  • High bleeding risk including any coagulopathy,
  • Lesion or condition considered to be a significant risk of major bleeding,
  • Major bleeding episode in the 30 days prior to study enrolment, or any active and clinically significant bleeding,
Show all 18Show fewer
  • Current treatment with P2Y12 inhibitors/adenosine diphosphate (ADP) receptor inhibitors (clopidogrel, prasugrel, ticagrelor, cangrelor) or phosphodiesterase inhibitors (dipyridamole), where the treating physician or patient does not wish to stop these medications,
  • Concurrent treatment with strong inhibitors of combined CYP3A4 and P-glycoprotein; or strong inducers of CYP3A4,
  • Any stroke within 1 month prior to enrolment,
  • Any previous history of a haemorrhagic or lacunar stroke,
  • Severe heart failure with known ejection fraction <30% or New York Heart Association class III or IV symptoms,
  • History of hypersensitivity or known contraindication to rivaroxaban,
  • Uncontrolled hypertension (systolic BP ≥180 mm Hg or diastolic BP ≥110 mm Hg), at the time of screening
  • Haemoglobin <90 g/L, or platelet count <100 x 109/L,
  • Significant liver disease (defined as Child-Pugh Class B or C) or Alanine Aminotransferase (ALT) >3 times upper normal limit,
  • Kidney transplant recipients with a functioning allograft, or scheduled for living-donor kidney transplant surgery,
  • All countries except Europe: Pregnancy or intention to become pregnant or breast-feeding; Europe only: Women who are not in a postmenopausal state, where postmenopausal is defined as no menses for 12 months without alternative medical causes,
  • Inability to understand or comply with the requirements of the study.

Trial locations and contacts

88 sites in 12 countries.

88 sites in 12 countries

India21 sites

  • All India Institute of Medical Sciences, Bathinda

    Bathinda, Punjab, 151001

  • AIIMS Bhubaneswar

    Bhubaneswar

  • Postgraduate Institute of Medical Education and Research, Chandigarh

    Chandigarh, 160012

  • Aysha Hospital

    Chennai, Tamil Nadu, 600010

  • Apollo Hospital

    Chennai, Tamil Nadu

  • KG Hospital, K.Govindaswamy Naidu Medical Trust

    Coimbatore, 641018

  • Noble Annex Hospital

    Hadapsar, Pune Maharashtra, 411013

  • Osmania General Hospital

    Hyderabad, Telangana, 500012

  • Citizens Hospital

    Hyderabad, Telangana, 500019

  • Nizam's Institute of Medical Sciences, Hyderabad

    Hyderabad, Telangana, 500082

  • Asian Institute of Nephrology and Urology

    Hyderabad

  • VS Hospital

    Kilpauk, 600010

  • Institute of Post-Graduate Medical Education and Research

    Kolkata, 700020

  • Nil Ratan Sircar Medical College and Hospital

    Kolkata

  • Aykai Super Speciality Hospital, Ludhiana

    Ludhiana, Punjab, 141010

  • Nutema Hospital

    Meerut, Uttar Pradesh

  • Muljibhai Patel Urological Hospital

    Nadiād, Gujarat, 387001

  • Government Hospital

    Nandyāl, 518501

  • Safdarjung Hospital

    New Delhi

  • Government Hospital

    Proddatūr, 516362

  • All India Institute Of Medical Sciences, Raipur

    Raipur, Chhattisgarh, 700020

Other trials in India

France17 sites

  • CH Boulogne-sur-Mer, (CH Boulogne-sur-Mer)

    Boulogne-sur-Mer, 62200

  • Hôpital de la Cavale Blanche, (CHU Brest)

    Brest, 29200

  • AURAL Colmar, (AURAL Colmar)

    Colmar, 68000

  • Hopital Louis Pasteur (CH Colmar)

    Colmar

  • AURAL Haguenau, (AURAL Haguenau)

    Haguenau, 67500

  • CH Haguenau, (CH Haguenau)

    Haguenau, 67500

  • CH Le Puy-en-Velay

    Le Puy-en-Velay

  • Hôpital Edouard Herriot, (CHU Lyon)

    Lyon, 69003

  • Hôpital de la Conception, (AP-HM)

    Marseille, 13005

  • AURAL Mulhouse, (AURAL Mulhouse)

    Mulhouse, 68100

  • CH Mulhouse, (CH Mulhouse)

    Mulhouse, 68100

  • Centre Hospitalier Régional Universitaire de Nancy

    Nancy, Meurthe-et-Moselle, 54035

  • Hôpital Pasteur, (CHU Nice)

    Nice, 06000

  • Hôpital de la Maison Blanche, (CHU Reims)

    Reims, 51092

  • AURAL Strasbourg, (AURAL Strasbourg)

    Strasbourg, 67000

  • Hôpital Bretonneau, (CHRU Tours)

    Tours, 37000

  • Hôpitaux de Brbaois, (ALTIR)

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Australia11 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Bendigo Health

    Bendigo, Victoria, 3552

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Logan Hospital

    Meadowbrook, Queensland, 4131

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Sunshine Hospital

    St Albans, Victoria, 3021

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Wollongong Hospital

    Wollongong, New South Wales, 2500

Other trials in Australia

Malaysia11 sites

  • Hospital Sultanah Bahiyah

    Alor Star, Kedah, 05460

  • Hospital Ampang

    Ampang

  • Hospital Raja Permaisuri Bainun, Ipoh

    Ipoh, Perak, 30450

  • Hospital Kajang

    Kajang, Selangor, 43000

  • Hospital Raja Perempuan Zainab II

    Kota Bharu, Kelantan, 15586

  • Hospital Queen Elizabeth, Kota Kinabalu

    Kota Kinabalu, Sabah, 88200

  • Hospital Canselor Tuanku Muhriz

    Kuala Lumpur, Kuala Lumpur, 56000

  • University of Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100

  • Hospital Pakar Sultanah Fatimah Muar

    Muar town

  • Hospital Seberang Jaya

    Seberang Jaya, Pulau Pinang, 13700

  • Hospital Tuanku Ja'afar, Seremban

    Seremban, Negeri Sembilan, 70300

Other trials in Malaysia

Tunisia8 sites

  • Fattouma Bourguiba Hospital

    Monastir

  • Hedi chaker Hospital

    Sfax

  • Sahloul Hospital

    Sousse

  • Charles Nicolle Hospital

    Tunis

  • La Rabta Hospital

    Tunis

  • Military Hospital

    Tunis

  • Mongi Slim Hospital

    Tunis

  • Taher Sfar Hospital

    Tunis

Other trials in Tunisia

Taiwan7 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Kaohsiung Chang-Gung Memorial Hospital

    Kaohsiung City, 833

  • Chung-Shan Medical University Hospital

    Taichung, 402

  • Wan fang Hospital

    Taipei, 116

  • Taipei Tzu Chi Hospital

    Taipei, 231

  • Fu-Jen Catholic University Hospital

    Taishan, New Taipei City, 243

  • Chang Gung Memorial Hospital, Linkou Medical Center

    Taoyuan, 333

Other trials in Taiwan

Saudi Arabia6 sites

  • Hemodialysis Care Project North Centre

    Al Yāsamīn, Riyadh Region, 13322

  • Hemodialysis King Abdullah Centre

    Al Yāsamīn, Riyadh Region, 13322

  • Dialysis Centre - King Abdul Aziz Medical City (KAMC)

    Ar Rimāyah, Riyadh Region, 11481

  • King Abdulaziz Medical City - Western Region - Jeddah, Ministry of National Guard - Health Affairs

    Jeddah

  • Hemodialysis Care Project South Centre

    Riyadh, Riyadh Region, 12799-6176

  • King Saud University Medical City (KSUMC)

    Riyadh

Other trials in Saudi Arabia

Canada2 sites

  • University of Alberta

    Edmonton

  • Research St. Joseph's - Hamilton

    Hamilton

Other trials in Canada

Singapore2 sites

  • Tan Tock Seng Hospital

    Singapore, 308433

  • Khoo Teck Puat Hospital

    Singapore, 767828

Other trials in Singapore

Belgium1 site

  • AZ Sint-Jan Brugge

    Bruges

Other trials in Belgium

Germany1 site

  • KRH Klinikum Siloah

    Hanover

Other trials in Germany

Nepal1 site

  • Tribhuvan University College

    Kathmandu

Other trials in Nepal

About this study

The TRACK trial is an investigator-initiated, multicentre, prospective, randomised, quadruple-blind (participant, healthcare provider, data collector, outcomes assessor), placebo-controlled trial. TRACK is a global trial and will be conducted in renal units that provide comprehensive CKD care. Approximately 2000 participants will be recruited.

The TRACK trial will assess a strategy of administering low dose rivaroxaban to reduce the risk of major adverse cardiac event (MACE) in people with Chronic Kidney Disease (CKD) stages 4 or 5 or dialysis-dependent kidney failure, and elevated cardiovascular (CV) risk (marked by a history of CAD or PAD, or non-haemorrhagic non-lacunar stroke OR diabetes mellitus OR age ≥65 years).

Read the detailed description

Background and Rationale Chronic Kidney Disease (CKD) is a major international health burden. Despite the unacceptably high burden of cardiovascular disease (CVD) and associated mortality, trial-data on the management of CVD in people with advanced stages of CKD and dialysis-dependent kidney failure are sparse. Risk of bleeding in CKD and dialysis-dependent kidney failure is increased when compared to the general population. Anticoagulant agents, such as rivaroxaban, are a core intervention in the prevention of CVD in the general population. Nevertheless, to mitigate trial risks, 90% of the trials evaluating this form of intervention exclude these patient populations.

The TRACK trial will evaluate the effect of low dose rivaroxaban in patients with CKD dialysis-dependent kidney failure. Other trials have demonstrated that rivaroxaban reduces the risk of major cardio-vascular outcomes in high risk patients, and the limited data showed that CKD status did not significantly affect this result.

Hypothesis Compared to placebo, low dose rivaroxaban reduces the risk of major adverse cardiac event (MACE) in people with CKD stages 4 or 5 or dialysis-dependent kidney failure, and elevated cardiovascular (CV) risk (marked by a history of CAD or PAD, or non-haemorrhagic non-lacunar stroke OR diabetes mellitus OR age ≥65 years).

Objectives The primary objective is to determine whether low dose rivaroxaban, compared to placebo, significantly reduces the risk of a composite outcome of;

  • CV death,
  • non-fatal myocardial infarction,
  • stroke, or
  • peripheral artery disease (PAD) events in people with CKD stages 4 or 5 or dialysis-dependent kidney failure, and an elevated CV risk (marked by a history of CAD or PAD, or non-haemorrhagic non-lacunar stroke OR diabetes mellitus OR age ≥65 years).

A full list of secondary objectives are detailed in the protocol, and include identifying risk reduction in the treatment group, and whether this treatment is cost effective.

Methodology The TRACK trial is an investigator-initiated, multicentre, prospective, randomised, quadruple-blind (participant, healthcare provider, data collector, outcomes assessor), placebo-controlled trial. The trial will test for the superiority of the trial intervention using a 1:1 allocation to parallel trial groups, on the basis of a pre-specified number of primary outcomes events.

This is a global trial and will be conducted in renal units that provide comprehensive CKD care. Approximately 2,000 participants will be recruited.

Being tested
Rivaroxaban 2.5 Mg Oral Tablet, Placebo
Keywords
Rivaroxaban
Medical subject headings
Renal Insufficiency, Chronic, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivaroxaban 2.5 Mg Oral TabletDrug

    Also called Xarelto

    Rivaroxaban is an orally administered selective direct factor Xa inhibitor.

  • PlaceboOther

    Rivaroxaban matched placebo

Study groups in NCT03969953
Study groupRoleWhat they receive
RivaroxabanExperimentalRivaroxaban 2.5mg, twice daily.
Receives: Drug: Rivaroxaban 2.5 Mg Oral Tablet
PlaceboPlacebo comparatorMatched placebo, twice daily.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Risk of Major Adverse Cardiac Event (MACE)

    To determine whether the intervention, compared to placebo, changes the risk of a composite outcome of;

    • CV death,
    • non-fatal myocardial infarction,
    • stroke, or
    • peripheral artery disease (PAD) events

    Measured: 5 years or trial closure

Secondary outcomes (9)

  1. Composite outcome of cardiovascular death, non-fatal myocardial infarction, or stroke.

    To determine whether the intervention, compared to placebo, changes the risk of a composite outcome of cardiovascular death, non-fatal myocardial infarction, or stroke.

    Measured: 5 years or trial closure

  2. Composite outcome of all-cause death, non-fatal myocardial infarction, stroke, or PAD events.

    To determine whether the intervention, compared to placebo, changes the risk of a composite of all-cause death, non-fatal myocardial infarction, stroke, or PAD events.

    Measured: 5 years or trial closure

  3. Composite outcome of all-cause death, non-fatal myocardial infarction, or stroke.

    To determine whether the intervention, compared to placebo, changes the risk of a composite of all-cause death, non-fatal myocardial infarction, or stroke.

    Measured: 5 years or trial closure

  4. Incidence of Cardiovascular Death

    To determine whether the intervention, compared to placebo, changes the risk of Cardiovascular Death

    Measured: 5 years or trial closure

  5. Incidence of Non-Fatal Myocardial Infarction

    To determine whether the intervention, compared to placebo, changes the risk of Non-Fatal Myocardial Infarction

    Measured: 5 years or trial closure

  6. Incidence of Stroke

    To determine whether the intervention, compared to placebo, changes the risk of Stroke

    Measured: 5 years or trial closure

  7. Incidence of PAD Events

    To determine whether the intervention, compared to placebo, changes the risk of PAD events

    Measured: 5 years or trial closure

  8. Net Clinical Benefit - incidence of MACE & Bleeding

    To determine whether the intervention, compared to placebo, changes the risk of a composite outcome of cardiovascular death, non-fatal myocardial infarction, stroke, PAD events, fatal bleeding, or symptomatic bleeding into a critical organ.

    Measured: 5 years or trial closure

  9. Incidence of Venous Thromboembolism

    To determine whether the intervention, compared to placebo, changes the risk of Venous Thromboembolism

    Measured: 5 years or trial closure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2019
  2. Study start18 Jan 2021
  3. Primary completion30 Oct 2025
  4. Study completion30 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The TRACK trial is an investigator-initiated, multicentre, prospective, randomised, quadruple-blind (participant, healthcare provider, data collector, outcomes assessor), placebo-controlled trial. The trial will test for the superiority of the trial intervention using a 1:1 allocation to parallel trial groups, on the basis of a pre-specified number of primary outcomes events.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,753 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03969953
Sponsor's protocol ID
0040139
Acronym
TRACK
Status last verified
Mar 2026
First submitted
27 May 2019
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Trial data will be disseminated in the form of a publication to a relevant clinical journal and presentation at appropriate scientific conferences. Individual participant data that underlie the results reported, after de-identification (text, tables, figures, and appendices), may be shared with Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Publications

  • Badve SV, Perkovic V, Jha V, Ramachandran R, Mushahar L, Menne J, De Vriese AS, Rossignol P, Flahault A, Al Ammari M, Skhiri H, Walsh M, Collister D, Liew A, Billot L, Bompoint S, Devaux A, Jun M, Lin E, Ramos da Cruz A, Ha JT, Eikelboom JW, Shaman A, Jardine MJ, Jesudason S, Wong MG, Anderson CS, Garg AX, Heerspink HJL, Monaghan H, Patel A, Mark PB, Wheeler DC, Lv J, Zuo L, Pilmore H, Gallagher M; TRACK Trial Investigators. Low-Dose Rivaroxaban and Cardiovascular Events in Advanced Kidney Disease: The TRACK Randomized Clinical Trial. JAMA. 2026 Jul 28;336(4):296-305. doi: 10.1001/jama.2026.9379.

    PubMed 42240165

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban 2.5 Mg Oral Tablet in people with Chronic Kidney Diseases and Dialysis-dependent Kidney Failure, run by The George Institute at 88 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in India, France, Australia, Malaysia, Tunisia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Risk of Major Adverse Cardiac Event (MACE) (time frame: 5 years or trial closure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03969953, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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