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NCT Number: NCT06906640

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.

Recruiting

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(IRIS-CKD Management Program): Education

Other

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.

(IRIS-CKD Management Program): GDMT

Other

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

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. UACR change

    Time frame: 6 months

    Change in UACR after 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Gretchen Sanders, MSN

CONTACT

[email protected]

919 6687829

Monica Leyva, MS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Bayer
  • Boehringer Ingelheim
  • Eli Lilly and Company

Registry information

Official study title

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

Acronym: IRIS-CKD

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 2, 2025
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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