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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05056909
Other study ID # Kidney ACTion
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


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
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