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

Duke University

Status: Not yet enrolling

Conditions: Type 2 DM; Chronic Kidney Disease(CKD); Type 2 Diabetes Mellitus (T2DM)

Treatments: Other: (IRIS-CKD Management Program): Education; Other: (IRIS-CKD Management Program): GDMT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06906640

Pro00116493_1

Details and patient eligibility

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.

Full 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.

Enrollment: 1,170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,170 participants in 2 patient groups

(IRIS-CKD Management Program): Education

Active Comparator group

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.

Treatment:

Other: (IRIS-CKD Management Program): Education

(IRIS-CKD Management Program): GDMT

Active Comparator group

Description:

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.

Treatment:

Other: (IRIS-CKD Management Program): GDMT

Other: (IRIS-CKD Management Program): Education