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Kidney AI-enabled Care Transformation

Primary Purpose

Chronic Kidney Diseases

Status
Withdrawn
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Kidney ACTion
Standard of care
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring chronic kidney disease, End stage kidney disease, Artificial intelligence, Patient engagement, Progression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Università Cattolica del Sacre Cuore
  • University of Leicester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of care

Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

Urinary Albumin to Creatinine Ratio (UACR)
Urine Albumin (mg/dL) / Urine Creatinine (g/dL) = UACR in mg/g ≈ Albumin excretion in mg/day

Secondary Outcome Measures

Full Information

First Posted
September 15, 2021
Last Updated
January 31, 2023
Sponsor
Medical University of Graz
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT05056909
Brief Title
Kidney AI-enabled Care Transformation
Official Title
Kidney AI-enabled Care Transformation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
funding refused
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
chronic kidney disease, End stage kidney disease, Artificial intelligence, Patient engagement, Progression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
CKD care, as routinely provided in the respective nephrology outpatient clinic.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
standard of care + Kidney ACTion AI-supported software for chronic kidney disease care.
Intervention Type
Device
Intervention Name(s)
Kidney ACTion
Intervention Description
AI-supported software for chronic kidney disease care
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Standard of care
Primary Outcome Measure Information:
Title
Urinary Albumin to Creatinine Ratio (UACR)
Description
Urine Albumin (mg/dL) / Urine Creatinine (g/dL) = UACR in mg/g ≈ Albumin excretion in mg/day
Time Frame
1 year after start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander H Kirsch, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Università Cattolica del Sacre Cuore
City
Roma
Country
Italy
Facility Name
University of Leicester
City
Leicester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Kidney AI-enabled Care Transformation

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