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NCT06906640NARecruiting

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

Duke University

Start Date

10/28/2025

Completion Date

4/1/2027

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

OTHER

(IRIS-CKD Management Program): Education

OTHER

(IRIS-CKD Management Program): GDMT

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Conditions

Chronic Kidney Disease(CKD)Type 2 DMType 2 Diabetes Mellitus (T2DM)

Locations

University of Alabama

Birmingham, Alabama 35233

United States

Orlando Health

St. Petersburg, Florida 33701

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Essentia Institute of Rural Health

Duluth, Minnesota 55805

United States

Duke University

Durham, North Carolina 27707

United States

Houston Methodist

Houston, Texas 77030

United States

Baylor Scott & White

Temple, Texas 76508

United States