Chronic Kidney DiseasesNCT05056909
Kidney AI-enabled Care Transformation
A study testing Kidney ACTion in people with Chronic Kidney Diseases, run by Medical University of Graz at 2 sites in 2 countries.
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Kidney ACTion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2022to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Kidney ACTion, Standard of care
- Keywords
- chronic kidney disease, End stage kidney disease, Artificial intelligence, Patient engagement, Progression
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Patient Participation, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney ACTionDevice
AI-supported software for chronic kidney disease care
Standard of careOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | CKD care, as routinely provided in the respective nephrology outpatient clinic. Receives: Other: Standard of care |
| Intervention | Experimental | standard of care + Kidney ACTion AI-supported software for chronic kidney disease care. Receives: Device: Kidney ACTion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Albumin to Creatinine Ratio (UACR)
Urine Albumin (mg/dL) / Urine Creatinine (g/dL) = UACR in mg/g ≈ Albumin excretion in mg/day
Measured: 1 year after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study startNov 2022 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionOct 2024 (estimated)
Why it stopped: funding refused
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Alexander H Kirsch, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056909
- Sponsor's protocol ID
- Kidney ACTion
- Status last verified
- Jan 2023
- First submitted
- 15 Sep 2021
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney AI-enabled Care Transformation
- ClinicalTrials.gov ID
- NCT05056909
- Acronym / sponsor ID
- Kidney ACTion
- Conditions
- Chronic Kidney Diseases
- Keywords
- chronic kidney disease, End stage kidney disease, Artificial intelligence, Patient engagement, Progression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding refused
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- 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
- Study start
- Nov 2022 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: Standard of careCKD care, as routinely provided in the respective nephrology outpatient clinic. |
| Intervention | Experimental | Device: Kidney ACTionstandard of care + Kidney ACTion AI-supported software for chronic kidney disease care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kidney ACTionAI-supported software for chronic kidney disease care | Device | Intervention |
| Standard of careStandard of care | Other | Standard of care |
Primary outcome
Urinary Albumin to Creatinine Ratio (UACR)
Time frame: 1 year after start of treatment
Urine Albumin (mg/dL) / Urine Creatinine (g/dL) = UACR in mg/g ≈ Albumin excretion in mg/day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander H Kirsch, MD principal investigator
Medical University of Graz
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kidney ACTion in people with Chronic Kidney Diseases, run by Medical University of Graz at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Albumin to Creatinine Ratio (UACR) (time frame: 1 year after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.