Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD) (Program 2)
Recruiting · NCT06906640 · Interventional (participants receive a specific treatment) · Lead sponsor: Duke University
View the official record on ClinicalTrials.gov →Interventions studied
(IRIS-CKD Management Program): Education(IRIS-CKD Management Program): GDMT
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
14 locations listed across 6 US states.
- University of Alabama - Birmingham, Alabama, United States
- University of Alabama - Birmingham, Alabama, United States
- Orlando Health - St. Petersburg, Florida, United States
- Orlando Health - St. Petersburg, Florida, United States
- University of Michigan - Ann Arbor, Michigan, United States
- University of Michigan - Ann Arbor, Michigan, United States
- Essentia Institute of Rural Health - Duluth, Minnesota, United States
- Essentia Institute of Rural Health - Duluth, Minnesota, United States
- Duke University - Durham, North Carolina, United States
- Duke University - Durham, North Carolina, United States
- Houston Methodist - Houston, Texas, United States
- Houston Methodist - Houston, Texas, United States
- Baylor Scott & White - Temple, Texas, United States
- Baylor Scott & White - Temple, Texas, United States