Clinical trial NCT05056909: Kidney AI-enabled Care Transformation
Official title: Kidney AI-enabled Care Transformation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: chronic kidney disease
End stage kidney disease
Artificial intelligence
Patient engagement
Progression
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Fraunhofer Institut für Arbeitswirtschaft und Organisation
name: Empirica
name: IN-JET APS
name: CNET Svenska AB
name: XIGME
name: European ESKD Patients' Federation
name: Catholic University of the Sacred Heart
name: University of Manchester
name: Università degli studi di Verona
name: University of Leeds
name: Roche Diagnostics International AG
name: Federación Nacional ALCER
First posted: 2021-09-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Urinary Albumin to Creatinine Ratio (UACR)
timeFrame: 1 year after start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Università Cattolica del Sacre Cuore
city: Leicester
country: United Kingdom
facility: University of Leicester
Study officials:
affiliation: Medical University of Graz
name: Alexander H Kirsch, MD
role: PRINCIPAL_INVESTIGATOR
References: