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

NCT ID: NCT06906640

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

1170 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 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.

Detailed Description

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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.

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 Management Program) is a comparative effectiveness 1:1 randomized trial of two interventions (Management vs. Education) to improve implementation of GDMT for CKD in 420 patients with T2D. All potential participants will receive educational materials on importance and opportunities to treat CKD before randomization. After randomization, both Education and Management participants will receive targeted educational materials on CKD and GDMT. The primary outcome will be an opportunity score of CKD GDMT at 6 months based on prescriptions.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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(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.

Group Type ACTIVE_COMPARATOR

(IRIS-CKD Management Program): Education

Intervention Type OTHER

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.

(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.

Group Type ACTIVE_COMPARATOR

(IRIS-CKD Management Program): Education

Intervention Type OTHER

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.

(IRIS-CKD Management Program): GDMT

Intervention Type OTHER

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.

Interventions

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(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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
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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Essentia Institute of Rural Health

Duluth, Minnesota, United States

Site Status RECRUITING

Duke University

Durham, North Carolina, United States

Site Status 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_1

Identifier Type: -

Identifier Source: org_study_id