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NCT Number: NCT06906627

Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 1) (IRIS-CKD)

IRIS-CKD is an implementation study to improve guideline-recommended screening of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.

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Key information

Conditions

Chronic Kidney Disease(CKD) Chronic Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Type 2 DM Type 2 Diabetes Mellitus (T2DM) Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama, Birmingham, Alabama, United States

Loading trial locations.

About this study

IRIS-CKD Screening Program: will focus on CKD screening in T2D. We will identify patients with T2D that have not received appropriate screening for CKD within the last 15 months and randomize patients to receive either a home kit to complete CKD screening ("home kit") versus a standard laboratory order ("laboratory order"). The primary objective is to evaluate whether delivery of home testing kits versus standard laboratory testing influences the degree to which patients receive guideline-recommended CKD screening. Patients will complete approximately 3 months of follow-up.

Who can participate

Healthy volunteers accepted: No

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

Screening Program-

Inclusion criteria

  • Adults with type 2 diabetes (T2D)
  • Receiving primary care within the healthcare system, Primary Care Provider (PCP) visit within the past 24 months (any PCP provider, including APP).
  • Lack of estimated glomerular filtration rate (eGFR) and/or urine albumin- creatinine ratio (UACR) measurement in the prior 15 months within the EHR

Exclusion criteria

  • Chronic kidney disease (CKD) diagnosis

Treatment and study plan

(IRIS-CKD Screening Program): Home Kit

Other

All participants approached for enrollment in Program 1 will receive National Kidney Foundational educational materials related to CKD screening in type 2 diabetes and study information. All enrolled participants will receive a message regarding study lab(s) results.

Home Test Kit: a kit delivered to participants homes with instructions to complete eGFR (fingerstick) and/or UACR (urine sample) testing, depending on which lab(s) are missing at baseline.

(IRIS-CKD Screening Program): Standard Lab Order

Other

ll participants approached for enrollment in Program 1 will receive National Kidney Foundation educational materials related to CKD screening in type 2 diabetes and study information. All enrolled participants will receive a message regarding study lab

Primary outcomes

  1. CKD Screening Lab Opportunity Score

    Time frame: 3 months

    Opportunity score of completion of missing guideline-recommended screening for CKD (eGFR and/or UACR) at 3 months.

    The opportunity score will be calculated as the ratio of the number of missing labs measured by month 3 divided by the number of missing labs at baseline.

Secondary outcomes

  1. CKD Screening Lab Opportunity Score by Subgroup

    Time frame: 3 months

    Opportunity score across subgroups by missing baseline screening labs: UACR only, eGFR only, or both.

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 (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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