A Minute for my Kidneys - Stadium V
| Registry | NCT07869849, acronym UMPMR-V |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, other |
| Enrollment | 312 (Estimated) |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche (Other); collaborators: Euraxi Pharma |
| Conditions | Chronic Kidney Diseases |
| Interventions | Dialysis (Drug) |
| Dates | start 2026-11-01 (estimated), primary completion 2029-12-01 (estimated), completion 2029-12-01 (estimated), first posted 2026-10-13, last updated 2026-10-13 |
| Locations | 1 site in France |
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All trials for Chronic Kidney Diseases All trials of Dialysis
The purpose of this study is to evaluate the effectiveness of the "One Minute for My Kidneys" program in reducing the time it takes for participants with stage V chronic kidney disease and other comorbidities to begin dialysis.
This is a multicenter, interventional, prospective, randomized, controlled, open-label clinical investigation.
The study population is composed of adults with stage V chronic kidney disease and other comorbidities.
Participants are offered enrollment in the clinical trial during a nephrology follow-up visit for their chronic kidney disease. Participants who are enrolled after signing an informed consent form and confirming their eligibility will then be randomized to either the group receiving access to the "1 Minute for My Kidneys" program in addition to standard of care, or the group receiving standard of care alone.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| "1 Minute for My Kidneys" App | Experimental | Drug: Dialysis | Participants in the experimental group will be monitored, in addition to receiving standard care, using the "1 Minute for My Kidneys" app. In addition, they will be required to complete a quality-of-life questionnaire (EQ-5D-5L, available directly in the app) once every 3 months. |
| Control group with quality of life | Active comparator | Drug: Dialysis | In addition to their usual care, participants in the control group will be asked to complete a questionnaire on quality of life during their nephrology appointment once every three months. |
Sex: All, ages: 18 Years to 80 Years
Inclusion Criteria: * Age ≥ 18 and ≤ 80; * Participants with stage V chronic kidney disease; * Participants with documented type 2 diabetes AND/OR documented glomerular disease (proteinuria > 1 g/24 h) AND/OR diagnosed with heart failure as recognized by a cardiologist according to the criteria of the European Society of Cardiology; * Participants who have and agree to use an internet connection; * Participants who speak and understand French and are able to complete the questionnaires; * Participants who have been informed and have signed an informed consent form; * Participants covered by a social security program. Exclusion Criteria: * Inability to use the app (blindness, severe intellectual disability); * Life expectancy of less than 6 months, as determined by the investigator; * Significant noncompliance, as determined by the investigator; * Participants for whom, in the event of end-stage renal disease, palliative care would be chosen over dialysis or transplantation; * Women who are pregnant or may become pregnant (of childbearing age and not using effective contraception) or who are breastfeeding; * Persons under legal guardianship (under legal protection or deprived of liberty by judicial or administrative decision); * A person unable to understand the information related to the study (due to linguistic, psychological, cognitive, or other reasons); * A participant currently enrolled in another clinical trial or study, or who has participated in another clinical trial or study that could have affected their health status within the 6 months prior to enrollment.
| Facility | City | Country | Status |
|---|---|---|---|
| Hôpital Privé La Louvière | Lille | France |