Kidney AI-enabled Care Transformation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Other: Standard of care; Device: Kidney ACTion

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander H Kirsch, MD; Phone Number: 12170 +43316385; Email: alexander.kirsch@medunigraz.at
• Study Contact Backup: Name: Kathrin Eller, MD; Phone Number: 12170 +43316385; Email: kathrin.eller@medunigraz.at

Study Locations

• Italy
  • Roma, Italy
    • Universita Cattolica del Sacre Cuore
    • Contact: Giovanni Gambaro, MD PhD
• United Kingdom
  • Leicester, United Kingdom
    • University of Leicester
    • Contact: Ruper Major, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: University of Leeds; Catholic University of the Sacred Heart; University of Manchester; Fraunhofer Institut für Arbeitswirtschaft und Organisation; Empirica; IN-JET APS; CNET Svenska AB; XIGME; European ESKD Patients' Federation; Università degli studi di Verona; Roche Diagnostics International AG; Federación Nacional ALCER
• Investigators: Principal Investigator: Alexander H Kirsch, MD, Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Progression; chronic kidney disease; Artificial intelligence; End stage kidney disease; Patient engagement
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: Kidney ACTion

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No