Kidney AI-enabled Care Transformation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2024-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of care

CKD care, as routinely provided in the respective nephrology outpatient clinic.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

Standard of care

Intervention

standard of care + Kidney ACTion AI-supported software for chronic kidney disease care.

Group Type EXPERIMENTAL

Kidney ACTion

Intervention Type DEVICE

AI-supported software for chronic kidney disease care

Interventions

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Kidney ACTion

AI-supported software for chronic kidney disease care

Intervention Type DEVICE

Standard of care

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No