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

Background: Chronic kidney disease (CKD) is characterized by long-term structural or functional kidney abnormalities, often progressing over decades and potentially leading to kidney failure, treatable only by dialysis or transplantation. Nutritional programs (NPs), physical activity (PA) programs, and mindfulness programs (MPs) can play a key role in conservative CKD management, aiming to slow the progression of symptoms, decrease drug load, reduce stress, and delay dialysis. KidneYou (Advice Pharma Group Srl) integrates nutrition, exercise, and MPs to improve the health of patients with CKD by promoting lifestyle changes and stress reduction. As an innovative medical tool, KidneYou is designed to address an unmet need by providing a nonpharmacological approach for better managing CKD, empowering patients to manage their condition more effectively and sustain a healthier lifestyle, which could ultimately lead to improved disease outcomes. Objective: This study aims to evaluate the efficacy and safety of KidneYou, a digital medical device that delivers personalized NPs, PA programs, and MPs to patients with CKD, in comparison with the standard of care. Methods: This is a multicenter, open-label, randomized, parallel-arm trial aimed at evaluating health improvement in patients with CKD exposed to a nonpharmacological treatment involving an NP, PA program, and MP delivered to the patient by digital technology (investigational arm) or a standard approach (paper diary and control arm) for 3 months. The primary aim of the study is to evaluate the efficacy of KidneYou, defined by the achievement of at least 1 of the 3 conditions described in the composite primary end point: a reduction of at least 10% of azoturia (gram per 24 h), an increase of at least 15% of distance (meters in the 6-min walk test), or a decrease of at least 10% of perceived stress in CKD KidneYou app users compared to CKD KidneYou app nonusers after 3 months. Results: Data will be analyzed and presented in accordance with international CONSORT (Consolidated Standards of Reporting Trials) guidelines. Recruitment began in July 2022 and stopped at all sites in April 2024. Data analysis is currently ongoing. The results are expected to be published in early 2026. Conclusions: The results of this trial will guide further studies on the impact of digital devices to help patients with CKD in improving their condition more effectively and sustain a healthier lifestyle, which could ultimately lead to improved disease outcomes. Trial Registration: ClinicalTrials.gov NCT05286632; https://clinicaltrials.gov/study/NCT05286632 International Registered Report Identifier (IRRID): DERR1-10.2196/75306