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

NCT06906627 | Recruiting

• 1 other identifier: Pro00116493
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

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

Keywords

CKD; T2DM; T2D; Type 2 Diabetes; Chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• CKD Screening Lab Opportunity Score

  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.

  3 months

Secondary Outcomes (1)

• CKD Screening Lab Opportunity Score by Subgroup

  3 months

Study Arms (2)

(IRIS-CKD Screening Program): Home Kit

ACTIVE COMPARATOR

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

Other: (IRIS-CKD Screening Program): Home Kit

(IRIS-CKD Screening Program): Standard Lab Testing

ACTIVE COMPARATOR

Standard Laboratory Testing: a traditional order will be placed into the Electronic Health Record (EHR) for eGFR and/or UACR testing, depending on which lab(s) are missing at baseline.

Other: (IRIS-CKD Screening Program): Standard Lab Order

Interventions

(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): Home Kit

(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

(IRIS-CKD Screening Program): Standard Lab Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Chronic kidney disease (CKD) diagnosis

Sponsors & Collaborators

• Duke University: lead
• Bayer: collaborator
• Boehringer Ingelheim: collaborator
• Eli Lilly and Company: collaborator

Study Sites (6)

University of Alabama

Birmingham, Alabama, 35233, United States

RECRUITING

Orlando Health

St. Petersburg, Florida, 33701, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Essentia Health

Duluth, Minnesota, 55805, United States

RECRUITING

Duke University

Durham, North Carolina, 27707, United States

RECRUITING

Baylor Scott & White

Temple, Texas, 76508, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Neha Pagidipati, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gretchen Sanders, MSN

CONTACT

919 6687829; gretchen.sanders@duke.edu

Monica Leyva, MS

CONTACT

monica.leyva@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: (IRIS-CKD Screening Program) is a randomized trial of delivery of a home testing kit for eGFR and/or UACR versus a standard laboratory order to increase rates of CKD screening in people who have lapsed beyond the recommended screening interval.

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: April 2, 2025
• Study Start: October 28, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)