Kidney AI-enabled Care Transformation

Study Overview
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Brief Summary
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In the Kidney ACTion study, CKD (Chronic Kidney Disease) patients at increased risk of progression to ESRD (End Stage Renal Disease) will be randomly assigned to either standard of care in a specialist nephrology outpatient clinic or to receiving CKD care supported by a novel AI-supported (Artificial Intelligence) software solution.

Detailed Description
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The Advancing American Kidney Health (AAKH) initiative has the goal of an ambitious 25% reduction of ESRD incidence by 2030. There is a lack of successful integrated care programs to reach this goal. The CKD population is very heterogeneous, this explains the different risk of progression to ESRD in different patients. However, Guidelines (GLs) for the treatment of CKD patients address risk factors identified in the CKD population at large. Thus, all CKD patients at the same stage receive similar treatments no matter the specific risk of developing ESRD. Up to 5.9% of Europeans have CKD stages 3-5. Treating this huge number of patients would strain health systems from both the organizational and economical point of view. It is reasonable to think that dedicating a personalized management specifically to CKD patients at high risk of progression would be cost-effective. GLs include behavioral (e.g. lifestyle, nutrition) as well as medical (e.g. drug therapy) interventions. Although patient's engagement and empowerment play a pivotal role in successful disease treatment, there is lack of evidence on practices to foster them in CKD patients. Kidney ACTion is a program that supports nephrologists in predicting disease progression for CKD patients and developing multidisciplinary, personalized, evidence-based treatment and care plans. Patient engagement and empowerment is a fundamental part of the program.

Official Title
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Kidney AI-enabled Care Transformation

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Device: Kidney ACTion
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged ≥18 years at the time of signing the informed consent Chronic kidney disease with eGFR <45 mL/min/1.73 m2 and UACR >300 mg/g creatinine (eGFR=estimated glomerular filtration rate; UACR=Urine Albumin-to-Creatinine Ratio) Patient is willing to comply with the study requirements for therapy during the entire study period Patient is capable of providing written informed consent to participate in the study Exclusion Criteria: Patients with underlying renal disease likely to receive disease-specific therapy other than SoC (Standard of Care) Patient expected to require renal replacement therapy within less than one year from study inclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care<br>CKD care, as routinely provided in the respective nephrology outpatient clinic. | Other: Standard of care<br>* Standard of care<br>|
| Experimental: Intervention<br>standard of care + Kidney ACTion AI-supported software for chronic kidney disease care. | Device: Kidney ACTion<br>* AI-supported software for chronic kidney disease care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Albumin to Creatinine Ratio (UACR) | Urine Albumin (mg/dL) / Urine Creatinine (g/dL) = UACR in mg/g ≈ Albumin excretion in mg/day | 1 year after start of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease, End stage kidney disease, Artificial intelligence, Patient engagement, Progression