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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06906640
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2025-02-21
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-25
• Study First Posted: 2025-04-02
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Study Start: 2025-07-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1170

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
CKD GDMT Opportunity Score at 6 months	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.

Secondary Outcome Measures

Name	Time	Method
CKD GDMT Opportunity Score at 3 months	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.
CKD GDMT Opportunity Score at 6 months weighted by dose	6 months	Change in opportunity score from baseline to 6 months weighted by prescribed dose of GDMT.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States