Kidney AI-enabled Care Transformation

• Sponsor: Medical University of Graz (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05056909
• Collaborator: Fraunhofer Institut für Arbeitswirtschaft und Organisation (Other), Empirica (Other), IN-JET APS (Other), CNET Svenska AB (Other), XIGME (Other), European ESKD Patients' Federation (Other), Catholic University of the Sacred Heart (Other), University of Manchester (Other), Università degli studi di Verona (Other), University of Leeds (Other), Roche Diagnostics International AG (Industry), Federación Nacional ALCER (Other)
• Enrollment: 160
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 23
• Patients Per Site: 80
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases	Device: Kidney ACTion; Other: Standard of care	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Kidney AI-enabled Care Transformation
• Anticipated Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Università Cattolica del Sacre Cuore	Roma		Italy
2	University of Leicester	Leicester		United Kingdom

Sponsors and Collaborators

• Medical University of Graz
• 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

Investigators

• Principal Investigator: Alexander H Kirsch, MD, Medical University of Graz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Graz
• ClinicalTrials.gov Identifier: NCT05056909
• Other Study ID Numbers: Kidney ACTion
• First Posted: Sep 27, 2021
• Last Update Posted: Sep 27, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Medical University of Graz: chronic kidney disease; End stage kidney disease; Artificial intelligence; Patient engagement; Progression
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic

Study Results

No Results Posted as of Sep 27, 2021