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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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