Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD) (Program 2)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Duke University
Study ID
NCT06906640
Status
Recruiting
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Conditions

  • Chronic Kidney Disease(CKD)
  • Type 2 DM
  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • (IRIS-CKD Management Program): Education — OTHER
    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.
  • (IRIS-CKD Management Program): GDMT — OTHER
    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.

Study Details

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.

Key Dates

Start date
Oct 28, 2025
Status verified
Apr 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: (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.
  • Active Comparator: (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.

Primary Outcome Measure

CKD GDMT Opportunity Score at 6 months [ Time Frame: 6 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35233
Sarah Machado
[email protected]
205-934-7649
Clare Lyas, MD (PRINCIPAL_INVESTIGATOR)
Orlando HealthSt. PetersburgFlorida33701
Timothy Marsh, DO (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Angie Westover
[email protected]
734-936-6467
Ilka Decker, MD (PRINCIPAL_INVESTIGATOR)
Essentia Institute of Rural HealthDuluthMinnesota55805
Haley Messenger
[email protected]
218-786-2077
Sreedhar Devathi, MD (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27707
John Middleton, MD (PRINCIPAL_INVESTIGATOR)
Baylor Scott & WhiteTempleTexas76508
Tariq Tariq, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama· Birmingham, ALOrlando Health· St. Petersburg, FLUniversity of Michigan· Ann Arbor, MIEssentia Institute of Rural Health· Duluth, MNDuke University· Durham, NCBaylor Scott & White· Temple, TX

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