Management Program for Chronic Kidney Disease in Type 2 Diabetes
(IRIS-CKD Trial)

Recruiting in Palo Alto (17 mi)

Overseen byNeha Pagidipati, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Duke University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Neha Pagidipati, MD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for people with type 2 diabetes in the U.S. who also have chronic kidney disease (CKD). It aims to improve how well they are screened and treated according to guidelines. Specific eligibility details aren't provided, but typically participants would need a diagnosis of both conditions.

Inclusion Criteria

Receiving primary care within the healthcare system, visit within 24 months (any PCP provider, including APP)

Adults with type 2 diabetes (T2D)

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

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Exclusion Criteria

I have Type 1 diabetes.

My kidney function is very low.

I have had a kidney transplant.

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Treatment Details

Interventions

IRIS-CKD Management Program (Other)

Trial OverviewThe IRIS-CKD study tests two programs: one focuses on Guideline-Directed Medical Therapy (GDMT) and the other on educational strategies. The goal is to see if these approaches can better manage CKD in patients with type 2 diabetes.

Participant Groups

2Treatment groups

Active Control

Group I: (IRIS-CKD Management Program): EducationActive Control1 Intervention

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 II: (IRIS-CKD Management Program): GDMTActive Control2 Interventions

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.