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Implementeringsprogram for at forbedre screening og styring for CKD i diabetes (IRIS-CKD) (program 2) (IRIS-CKD)

28. september 2026 opdateret af: Duke University

Implementeringsprogram for at forbedre screening og styring for CKD i diabetes (program 2) (IRIS-CKD)

IRIS-CKD is a two-program implementation study to improve guideline-recommended screening and treatment of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

IRIS-CKD Management Program: will compare prescriptions for guideline-directed medical therapies (GDMT) during the study period. To account for variable GDMT requirements, we will use opportunity scores to compare intervention arms. Patients will be screened, identified and undergo consent by the study site. Patients will receive educational materials related to CKD screening in T2D and details regarding the testing intervention study as per site specific recruitment requirements. The primary objective is to determine whether implementing a guided management program versus education alone will improve prescription of GDMT for people with CKD and T2D. Patients will complete approximately 6 months of follow-up.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

212

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • Rekruttering
        • University of Alabama
        • Ledende efterforsker:
          • Clare Lyas, MD
        • Kontakt:
    • Florida
      • St. Petersburg, Florida, Forenede Stater, 33701
        • Rekruttering
        • Orlando Health
        • Ledende efterforsker:
          • Timothy Marsh, DO
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • Rekruttering
        • University of Michigan
        • Kontakt:
        • Ledende efterforsker:
          • Ilka Decker, MD
    • Minnesota
      • Duluth, Minnesota, Forenede Stater, 55805
        • Rekruttering
        • Essentia Institute of Rural Health
        • Ledende efterforsker:
          • Sreedhar Devathi, MD
        • Kontakt:
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27707
        • Rekruttering
        • Duke University
        • Ledende efterforsker:
          • John Middleton, MD
        • Kontakt:
    • Texas
      • Houston, Texas, Forenede Stater, 77030
      • Temple, Texas, Forenede Stater, 76508
        • Rekruttering
        • Baylor Scott & White
        • Ledende efterforsker:
          • Tariq Tariq, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • (CKD Management)

    • Adults with type 2 diabetes (T2D)

    • Receiving primary care within the healthcare system, visit within 24 months (any PCP provider, including APP)

    • Evidence of CKD based on laboratory testing within the past 2 years (must be confirmed during screening if not checked within 3 months of enrollment):

      • UACR >300 mg/g or
      • eGFR <45 ml/min/1.73 m2 or
      • UACR ≥30 mg/g with eGFR <60 ml/min/1.73 m2

    • Receiving <100% GDMT at baseline. For patients with UACR <30 mg/g, GDMT includes sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy. For all other eligible patients, GDMT includes ACEi/ARB, SGLT2i, and Finerenone, unless contraindications for any of these therapies exist (e.g., hyperkalemia, diabetic ketoacidosis, etc.).

Exclusion Criteria:

  • (CKD Management)

    • Type 1 diabetes
    • Most recent eGFR <20 ml/min/1.73 m2
    • Prior kidney transplant
    • Autosomal dominant polycystic kidney disease (ADPKD)
    • Active pregnancy or plans for conception within 1 year

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: (IRIS-CKD Management Program): Education

Education: Participants will receive targeted educational materials related to their stage of CKD, including recommendations for potential GDMT to discuss with their primary care provider.
Andet: (IRIS-CKD Management Program): Education

Patients randomized to the education arm will receive targeted education materials regarding their severity of CKD, including the potential for additional GDMT to slow CKD progression to discuss with their Primary Care Provider (PCP). At 6 months, the study pharmacist (or APP) will order repeat eGFR and UACR after 6 months to standardize CKD follow up during the study period.
Aktiv komparator: (IRIS-CKD Management Program): GDMT

Management: Participants will receive targeted educational materials, along with GDMT prescription, dose titration, and laboratory monitoring by a pharmacist/APP, as necessary, with guidance from a centralized algorithm and oversight from a nephrologist site PI.
Andet: (IRIS-CKD Management Program): Education

Patients randomized to the education arm will receive targeted education materials regarding their severity of CKD, including the potential for additional GDMT to slow CKD progression to discuss with their Primary Care Provider (PCP). At 6 months, the study pharmacist (or APP) will order repeat eGFR and UACR after 6 months to standardize CKD follow up during the study period.

Andet: (IRIS-CKD Management Program): GDMT

Patients randomized to the education arm will receive targeted education materials regarding their severity of CKD, including the potential for additional GDMT to slow CKD progression to discuss with their PCP. At 6 months, the study pharmacist (or APP) will order repeat eGFR and UACR after 6 months to standardize CKD follow up during the study period. Plus, receive guided care by APP.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
CKD GDMT Opportunity Score at 6 months
Tidsramme: 6 months

Opportunity score of GDMT prescriptions at 6 months that were missing at baseline.

The score will include prescriptions for GDMT that are active at month 6 or the loss of an indication for the GDMT.
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
CKD GDMT Opportunity Score at 6 months weighted by dose
Tidsramme: 6 months

Change in opportunity score from baseline to 6 months weighted by prescribed dose of GDMT.
6 months
CKD GDMT Opportunity Score at 3 months
Tidsramme: 3 months

Opportunity score of GDMT prescriptions at 3 months that were missing at baseline.

The score will include prescriptions for GDMT that are active at month 3 or the loss of an indication for the GDMT.
3 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
UACR change
Tidsramme: 6 months

Change in UACR after 6 months
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Duke University

Samarbejdspartnere

Bayer
Boehringer Ingelheim

Efterforskere

  • Ledende efterforsker: Neha Pagidipati, MD, Duke University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. oktober 2025

Primær færdiggørelse (Anslået)

1. april 2027

Studieafslutning (Anslået)

1. april 2027

Datoer for studieregistrering

Først indsendt

21. februar 2025

Først indsendt, der opfyldte QC-kriterier

25. marts 2025

Først opslået (Faktiske)

2. april 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. september 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Pro00116493_1

Plan for individuelle deltagerdata (IPD)

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