Kidney AI-enabled Care Transformation

NCT05056909 | Withdrawn

• 1 other identifier: Kidney ACTion
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

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.

Conditions

Chronic Kidney Diseases

Keywords

chronic kidney disease; End stage kidney disease; Artificial intelligence; Patient engagement; Progression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

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

Other: Standard of care

Intervention

EXPERIMENTAL

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

Device: Kidney ACTion

Interventions

Kidney ACTion DEVICE

AI-supported software for chronic kidney disease care

Intervention

Standard of care OTHER

Standard of care

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with underlying renal disease likely to receive disease-specific therapy other than SoC (Standard of Care)

Sponsors & Collaborators

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

Study Sites (2)

Università Cattolica del Sacre Cuore

Roma, Italy

Location

University of Leicester

Leicester, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Patient Participation; Disease Progression

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Alexander H Kirsch, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 27, 2021
• Study Start: November 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); GB (1)