IRIS-CKD Program to Improve Screening and Management for CKD in Diabetes

This study, called IRIS-CKD, is looking for people with type 2 diabetes (T2D) and chronic kidney disease (CKD) to improve how these conditions are screened and managed. You might be eligible if you are an adult with T2D, receive primary care within the healthcare system, and have evidence of CKD based on recent lab tests (UACR >300 mg/g or eGFR <45 ml/min/1.73m2). The study is testing two approaches: an education program that provides materials about CKD severity and potential treatments, and a guided management program that also involves a study pharmacist or advanced practice provider (APP) ordering follow-up tests. The main goal is to see if these programs increase the use of guideline-directed medical therapies (GDMT) for CKD. The study is currently unclear on its recruitment status and plans to enroll 420 participants.

Study design
This is an interventional study comparing a guided management program to an education-only program. It aims to enroll 420 participants.
What's involved
You would receive educational materials and potentially have a study pharmacist or APP order repeat lab tests. You will complete approximately 6 months of follow-up.
Compensation
Not stated in the trial record.
Follow-up
Participants will have approximately 6 months of follow-up after the intervention.

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NCT06906640

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

Recruiting
NAAges 18+Interventional
Duke University
~420 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:(IRIS-CKD Management Program): Education(IRIS-CKD Management Program): GDMT

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
CKD GDMT Opportunity Score at 6 months
Measured over 6 months
Chronic Kidney Disease(CKD)
Type 2 DM
Type 2 Diabetes Mellitus (T2DM)
7 sites across 6 states
Texas2
Alabama1
Florida1
Michigan1
Minnesota1
North Carolina1
  • Neha Pagidipati, MD · PRINCIPAL_INVESTIGATOR · Duke University

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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
  • CKD GDMT Opportunity Score at 6 months6 months

    Opportunity score of GDMT prescriptions at 6 months that were missing at baseline. The score will include prescriptions for GDMT that are active at month 6 or the loss of an indication for the GDMT.