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

NCT ID: NCT06906627

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-28

Study Completion Date

2027-04-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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CKD T2DM T2D Type 2 Diabetes Chronic kidney disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

(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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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(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.

Group Type ACTIVE_COMPARATOR

(IRIS-CKD Screening Program): Home Kit

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

(IRIS-CKD Screening Program): Standard Lab Order

Intervention Type 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

Interventions

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(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.

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neha Pagidipati, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Ochsner

New Orleans, Louisiana, United States

Site Status NOT_YET_RECRUITING

Essentia Health

Duluth, Minnesota, United States

Site Status RECRUITING

Duke University

Durham, North Carolina, United States

Site Status RECRUITING

Baylor Scott & White

Temple, Texas, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Gretchen Sanders, MSN

Role: CONTACT

Phone: 919 6687829

Email: [email protected]

Monica Leyva, MS

Role: CONTACT

Email: [email protected]

Other Identifiers

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Pro00116493

Identifier Type: -

Identifier Source: org_study_id