Clinical trial NCT06906640: Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD) (Program 2)
Official title: Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 2) (IRIS-CKD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease(CKD)
Type 2 DM
Type 2 Diabetes Mellitus (T2DM)
Keywords: CKD
T2DM
T2D
Type 2 Diabetes
Chronic kidney disease
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Bayer
name: Boehringer Ingelheim
name: Eli Lilly and Company
First posted: 2025-04-02
Enrollment: 1170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: (IRIS-CKD Management Program) is a comparative effectiveness 1:1 randomized trial of two interventions (Management vs. Education) to improve implementation of GDMT for CKD in 420 patients with T2D. All potential participants will receive educational materials on importance and opportunities to treat CKD before randomization. After randomization, both Education and Management participants will receive targeted educational materials on CKD and GDMT. The primary outcome will be an opportunity score of CKD GDMT at 6 months based on prescriptions.
Primary purpose: OTHER

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: CKD GDMT Opportunity Score at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: CKD GDMT Opportunity Score at 6 months weighted by dose
timeFrame: 6 months
measure: CKD GDMT Opportunity Score at 3 months
timeFrame: 3 months
Other outcomes:
measure: UACR change
timeFrame: 6 months
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Neha Pagidipati, MD
role: PRINCIPAL_INVESTIGATOR
References: