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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07634718

Acronym

ITINERANCE

Enrollment

125000

Registered

2026-06-09

Start date

2026-06-01

Completion date

2032-06-01

Last updated

2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Renal Failure , Chronic

Keywords

implementation, heatlh-related message, Renal and cardiovascular event

Brief summary

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.

Interventions

OTHERHealth-related messages

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention model description

ITINERANCE is a controlled, multicentric, randomized cluster trial in two parallel arms. Randomization units will be Medical Laboratories (ML) sites. All ML sites will be randomized concomitantly.

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Major Adverse Renal and Cardiovascular Events (MARCE) occurrence	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

Measure	Time frame	Description
Specific health outcomes	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
Reimbursement claims of medications of special interest and visits to general practitioners and to specialists in cardiology, nephrology and diabetology	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
Biological characteristics	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
Impact on medical costs	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

Countries

France

Contacts

CONTACTSamy Hadjadj, PU-PH

samy.hadjadj@univ-nantes.fr+33244768545

CONTACTSonia Brinet

sonia.brinet@chu-nantes.fr+33253526126

PRINCIPAL_INVESTIGATORSamy Hadjadj, MD

Nantes University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026