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

April 6, 2026 updated by: Duke University

Implementation pRogram to Improve Screening and Management for CKD in Diabetes (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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University Of Alabama
        • Contact:
        • Principal Investigator:
          • Clare Lyas, MD
    • Florida
      • St. Petersburg, Florida, United States, 33701
        • Recruiting
        • Orlando Health
        • Principal Investigator:
          • Timothy Marsh, DO
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Ilka Decker
    • Minnesota
      • Duluth, Minnesota, United States, 55805
    • North Carolina
      • Durham, North Carolina, United States, 27707
        • Recruiting
        • Duke University
        • Principal Investigator:
          • John Middleton, MD
        • Contact:
    • Texas
      • Temple, Texas, United States, 76508
        • Recruiting
        • Baylor Scott & White
        • Principal Investigator:
          • Tariq Shafi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: (IRIS-CKD Screening Program): Home Kit
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

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.
Active Comparator: (IRIS-CKD Screening Program): Standard Lab Testing
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Eli Lilly and Company
Bayer
Boehringer Ingelheim

Investigators

  • Principal Investigator: Neha Pagidipati, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00116493

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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