- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05056909
Kidney AI-enabled Care Transformation
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Alexander H Kirsch, MD
- Telefonnummer: 12170 +43316385
- E-mail: alexander.kirsch@medunigraz.at
Undersøgelse Kontakt Backup
- Navn: Kathrin Eller, MD
- Telefonnummer: 12170 +43316385
- E-mail: kathrin.eller@medunigraz.at
Studiesteder
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Leicester, Det Forenede Kongerige
- University of Leicester
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Kontakt:
- Ruper Major, MD
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Roma, Italien
- Universita Cattolica del Sacre Cuore
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Kontakt:
- Giovanni Gambaro, MD PhD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Standard of care
CKD care, as routinely provided in the respective nephrology outpatient clinic.
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Standard for pleje
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Eksperimentel: Intervention
standard of care + Kidney ACTion AI-supported software for chronic kidney disease care.
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AI-supported software for chronic kidney disease care
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Urinary Albumin to Creatinine Ratio (UACR)
Tidsramme: 1 year after start of treatment
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Urine Albumin (mg/dL) / Urine Creatinine (g/dL) = UACR in mg/g ≈ Albumin excretion in mg/day
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1 year after start of treatment
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Alexander H Kirsch, MD, Medical University of Graz
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Kidney ACTion
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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