Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD) (Program 2)
ID: NCT06906640
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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.
Read Full Scientific Objectives & Methods
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 scores to compare intervention arms. Patients will be screened, identified and undergo consent by the study site. Patients will receive educational materials related to CKD screening in T2D and details regarding the testing intervention study as per site specific recruitment requirements. The primary objective is to determine whether implementing a guided management program versus education alone will improve prescription of GDMT for people with CKD and T2D. Patients will complete approximately 6 months of follow-up.
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.
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.
Treatment Arms Description
Education: Participants will receive targeted educational materials related to their stage of CKD, including recommendations for potential GDMT to discuss with their primary care provider.
Management: Participants will receive targeted educational materials, along with GDMT prescription, dose titration, and laboratory monitoring by a pharmacist/APP, as necessary, with guidance from a centralized algorithm and oversight from a nephrologist site PI.
- (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.).
- (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
Primary Outcome Measures
- CKD GDMT Opportunity Score at 6 months — Time Frame: 6 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.
View Secondary Outcome Measures (2)
- CKD GDMT Opportunity Score at 6 months weighted by dose — Time Frame: 6 months
Change in opportunity score from baseline to 6 months weighted by prescribed dose of GDMT.
- CKD GDMT Opportunity Score at 3 months — Time Frame: 3 months
Opportunity score of GDMT prescriptions at 3 months that were missing at baseline. The score will include prescriptions for GDMT that are active at month 3 or the loss of an indication for the GDMT.
This trial is recruiting at 7 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 7 Facilities & Contact Sites
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View Official Medical/Scientific Title
Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 2) (IRIS-CKD)