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

Last updated: April 6, 2026
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Diabetes Mellitus, Type 2

Treatment

(IRIS-CKD Management Program): GDMT

(IRIS-CKD Management Program): Education

Clinical Study ID

NCT06906640
Pro00116493_1
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 beconfirmed 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, GDMTincludes sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy. For allother eligible patients, GDMT includes ACEi/ARB, SGLT2i, and Finerenone, unlesscontraindications for any of these therapies exist (e.g., hyperkalemia,diabetic ketoacidosis, etc.).

Exclusion

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

Study Design

Total Participants: 420
Treatment Group(s): 2
Primary Treatment: (IRIS-CKD Management Program): GDMT
Phase:
Study Start date:
October 28, 2025
Estimated Completion Date:
April 01, 2027

Study Description

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.

Connect with a study center

  • University of Alabama

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • University of Alabama

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Site Not Available

  • Orlando Health

    St. Petersburg, Florida 33701
    United States

    Active - Recruiting

  • Orlando Health

    St. Petersburg 4171563, Florida 4155751 33701
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Essentia Institute of Rural Health

    Duluth, Minnesota 55805
    United States

    Active - Recruiting

  • Essentia Institute of Rural Health

    Duluth 5024719, Minnesota 5037779 55805
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27707
    United States

    Active - Recruiting

  • Duke University

    Durham 4464368, North Carolina 4482348 27707
    United States

    Site Not Available

  • Baylor Scott & White

    Temple, Texas 76508
    United States

    Active - Recruiting

  • Baylor Scott & White

    Temple 4735966, Texas 4736286 76508
    United States

    Site Not Available

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