Evaluating the Safety and Performance of the KidneYou App for Chronic Kidney Disease: Protocol for an Italian Multicenter, Randomized, Open-Label, Premarket Study.

The KidneYou app integrates nutritional programs, physical activity programs, and mindfulness programs as a nonpharmacological digital medical device for chronic kidney disease management.

• KidneYou is developed by Advice Pharma Group Srl.
• The app is designed to promote lifestyle changes and stress reduction in CKD patients.
• It is described as addressing 'an unmet need by providing a nonpharmacological approach for better managing CKD.'
• The device aims to empower patients to manage their condition more effectively and sustain a healthier lifestyle.

The study is designed as a multicenter, open-label, randomized, parallel-arm trial comparing the KidneYou app to standard of care over 3 months.

• The investigational arm uses the KidneYou digital app to deliver nutritional, physical activity, and mindfulness programs.
• The control arm uses a standard approach with a paper diary.
• The trial duration for each participant is 3 months.
• The study is described as a premarket study conducted across multiple Italian centers.
• Data will be analyzed and presented in accordance with international CONSORT guidelines.

The primary endpoint is a composite measure requiring achievement of at least one of three conditions related to azoturia, walking distance, or perceived stress.

• Condition 1: a reduction of at least 10% of azoturia (grams per 24 hours).
• Condition 2: an increase of at least 15% of distance in meters on the 6-minute walk test.
• Condition 3: a decrease of at least 10% of perceived stress.
• The composite primary endpoint compares KidneYou app users to CKD KidneYou app nonusers after 3 months.

Recruitment for the trial began in July 2022 and was stopped at all sites in April 2024.

• Recruitment spanned approximately 21 months across multiple Italian sites.
• Data analysis was described as 'currently ongoing' at the time of publication.
• Results are expected to be published in early 2026.

Chronic kidney disease is characterized as a long-term condition that can progress over decades and potentially lead to kidney failure requiring dialysis or transplantation.

• CKD involves long-term structural or functional kidney abnormalities.
• Kidney failure from CKD is treatable only by dialysis or transplantation.
• Nutritional programs, physical activity programs, and mindfulness programs 'can play a key role in conservative CKD management.'
• Conservative management aims to 'slow the progression of symptoms, decrease drug load, reduce stress, and delay dialysis.'