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Status:

RECRUITING

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

Lead Sponsor:

Duke University

Collaborating Sponsors:

Bayer

Boehringer Ingelheim

Conditions:

Chronic Kidney Disease(CKD)

Type 2 DM

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 scor...

Eligibility Criteria

Inclusion

  • (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

  • (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

Key Trial Info

Start Date :

October 28 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2027

Estimated Enrollment :

420 Patients enrolled

Trial Details

Trial ID

NCT06906640

Start Date

October 28 2025

End Date

April 1 2027

Last Update

December 12 2025

Active Locations (3)

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Page 1 of 1 (3 locations)

1

University of Alabama

Birmingham, Alabama, United States, 35233

2

Essentia Institute of Rural Health

Duluth, Minnesota, United States, 55805

3

Duke University

Durham, North Carolina, United States, 27707