Kidney AI-enabled Care Transformation

Chronic Kidney Diseases Clinical Trial

Official title:

Kidney AI-enabled Care Transformation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05056909
• Other study ID #: Kidney ACTion
• Status: Withdrawn
• Phase: N/A
• Start date: November 2022
• Est. completion date: October 2024

Study information

• Verified date: January 2023
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Device:
• Kidney ACTion
AI-supported software for chronic kidney disease care

Other:
• Standard of care
Standard of care

Locations

Country	Name	City	State
Italy	Università Cattolica del Sacre Cuore	Roma
United Kingdom	University of Leicester	Leicester

Sponsors (13)

Lead Sponsor	Collaborator
Medical University of Graz	Catholic University of the Sacred Heart, CNET Svenska AB, Empirica, European ESKD Patients' Federation, Federación Nacional ALCER, Fraunhofer Institut für Arbeitswirtschaft und Organisation, IN-JET APS, Roche Diagnostics International AG, Università degli studi di Verona, University of Leeds, University of Manchester, XIGME

Countries where clinical trial is conducted

Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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