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

April 6, 2026 updated by: Duke University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

420

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
        • Principal Investigator:
          • Clare Lyas, MD
        • Contact:
    • 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, MD
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Essentia Institute of Rural Health
        • Principal Investigator:
          • Sreedhar Devathi, MD
        • Contact:
    • 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 Tariq, 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

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 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 Management Program): Education
Education: Participants will receive targeted educational materials related to their stage of CKD, including recommendations for potential GDMT to discuss with their primary care provider.
Other: (IRIS-CKD Management Program): Education
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.
Active Comparator: (IRIS-CKD Management Program): GDMT
Management: Participants will receive targeted educational materials, along with GDMT prescription, dose titration, and laboratory monitoring by a pharmacist/APP, as necessary, with guidance from a centralized algorithm and oversight from a nephrologist site PI.
Other: (IRIS-CKD Management Program): Education
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.
Other: (IRIS-CKD Management Program): GDMT
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
UACR change
Time Frame: 6 months
Change in UACR after 6 months
6 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_1

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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