Chronic Kidney Diseases
Conditions
Keywords
chronic kidney disease, End stage kidney disease, Artificial intelligence, Patient engagement, Progression
Brief summary
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
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.
Interventions
DEVICEKidney ACTion
AI-supported software for chronic kidney disease care
OTHERStandard of care
Standard of care
Sponsors
Fraunhofer Institut für Arbeitswirtschaft und Organisation
Empirica
IN-JET APS
CNET Svenska AB
XIGME
European ESKD Patients' Federation
Catholic University of the Sacred Heart
University of Manchester
Università degli studi di Verona
University of Leeds
Roche Diagnostics International AG
Federación Nacional ALCER
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Albumin to Creatinine Ratio (UACR) | 1 year after start of treatment | Urine Albumin (mg/dL) / Urine Creatinine (g/dL) = UACR in mg/g ≈ Albumin excretion in mg/day |
Countries
Italy, United Kingdom
Outcome results
None listed