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NCT Number: NCT07634718

Implementation Trial In patieNts With rEnal failuRe and diAbetes for Major Adverse reNal and Cardiovascular Events

The goal of this clinical study is to establish if the use of public health-related messages, designed and disseminated to a targeted population, will result in tangible improvements in patient outcomes and healthcare practices.

Specific health-related messages oriented towards patients, through their biological results and HealthCare Professionals (HCPs), will be sent to participants included in the intervention group. The control group will not receive any health-related message (routine care).

The aim is to evaluate if this intervention leads to differences in Major Adverse Renal and Cardiovascular Events (MARCE), compared to routine care (no dissemination of health messages) in patients suffering in diabetes and renal failure.

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Key information

Conditions

Diabetes Chronic Disease Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Failure , Chronic Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main inclusion criteria:

  • Subject attending a ML participating to the study
  • Subject presenting a HbA1c ≥ 6.5% and an estimated GFR (CKD-EPI formula) in the range 60 to 15 ml/min (included) and/or albumin to creatinine ratio ≥ 300 mg albumin/g creatinine (or 30 mg/mmol creatinine), on the same biological determination.

Main exclusion criteria:

  • Subject previously identified as opposed to the use of their medical data and/or access of their SNDS data,
  • Subject not registered to the French social security system,
  • Subject with estimated GFR < 15 ml/min on the day of inclusion

Treatment and study plan

Health-related messages

Other

Patient will be included in the intervention according to the laboratory's randomization arm.The intervention consists in delivering patient information messages in laboratory reports, providing access to an educational video for patients and a specific message for the prescribing physician in the intervention arm, without modifying patient care.

Primary outcomes

  1. Major Adverse Renal and Cardiovascular Events (MARCE) occurrence

    Time frame: 2 years after randomization and dissemination of health-related messages

    Change in Major Adverse Renal and Cardiovascular Events (MARCE) occurrence defined as a composite outcome including the following items (first occurring):

    • All-cause death
    • Myocardial infarction (universal definition)
    • Stroke (universal definition)
    • Sustained (over 45 days) use of renal replacement therapy
    • Heart failure leading to hospitalization (definition by the European Society of Cardiology)

Secondary outcomes

  1. Specific health outcomes

    Time frame: 2 years after the randomization and dissemination of health-related messages

    Change in specific health outcomes (separately analysed):

    • All-cause death
    • Myocardial infarction
    • Stroke
    • Sustained (over 1 month) use of renal replacement therapy
    • Heart failure leading to hospitalization
    • Lower limb amputation, with special information on the site of amputation (toe, transmetatarsal, transtibial, transfemoral)
    • Arterial revascularization in the coronary, cerebrovascular and/or lower aorta/lower limb territories
    • Severe diabetic retinopathy (laser procedure, eye surgery for diabetes complication and intravitreal injection associated with specific drug delivery and/or their combinations

  2. Reimbursement claims of medications of special interest and visits to general practitioners and to specialists in cardiology, nephrology and diabetology

    Time frame: 6 months and 2 years after randomization and dissemination of health-related messages

    Change in Reimbursement claims of medications of special interest and visits to general practitioners and to specialists in cardiology, nephrology and diabetology

  3. Biological characteristics

    Time frame: 2 years before and after randomization and dissemination of health-related messages

    Changes in biological results of: lipids, liver and renal functions, blood cell count, HbA1c, CRP , Blood chemistry and Blood and urine urea

  4. Impact on medical costs

    Time frame: 2 years after randomization and dissemination of health-related messages

    Changes between groups:

    • in euros of patients healthcare costs,
    • in type of costs (consultation, hospitalisation, etc),
    • in euros of the intervention impact,
    • in QALY of cost-effectiveness

Study contacts

Contact information is provided by the study sponsor or research team.

Samy Hadjadj, PU-PH

CONTACT

[email protected]

+33244768545 ext. +33244768545

Sonia Brinet

CONTACT

[email protected]

+33253526126

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Biogroup Laboratoire de biologie médicale
  • Hospices Civils de Lyon
  • Santé publique France-InVS (Institut National de Veille sanitaire)
  • University Hospital, Toulouse
  • University Hospital, Tours

Registry information

Acronym: ITINERANCE

Important dates

Study start
2026
Primary completion
2029
Study completion
2032
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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