Recruiting
Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD) (Program 2)
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.
ClinicalTrials.gov IDNCT06906640
PhaseNA
Enrollment212
SponsorDuke University
Age18 Years and older
SexALL
Conditions studied
Chronic Kidney Disease(CKD), Type 2 DM, Type 2 Diabetes Mellitus (T2DM)
About this study
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.
Interventions
- Other: (IRIS-CKD Management Program): Education — Patients randomized to the education arm will receive targeted education materials regarding their severity of CKD, including the potential for additional GDMT to slow CKD progression to discuss with their Primary Care Provider (PCP). At 6 months, the study pharmacist (or APP) will order repeat eGFR and UACR after 6 months to standardize CKD follow up during the study period.
- Other: (IRIS-CKD Management Program): GDMT — Patients randomized to the education arm will receive targeted education materials regarding their severity of CKD, including the potential for additional GDMT to slow CKD progression to discuss with their PCP. At 6 months, the study pharmacist (or APP) will order repeat eGFR and UACR after 6 months to standardize CKD follow up during the study period. Plus, receive guided care by APP.
Primary outcomes
- CKD GDMT Opportunity Score at 6 months (6 months)
Eligibility information
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
Study 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
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-22.