Screening Program for Chronic Kidney Disease in Type 2 Diabetes

(IRIS-CKD Trial)

Recruiting at 5 trial locations

Overseen By Gretchen Sanders, MSN

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 an implementation study to improve guideline-recommended screening 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 adults with type 2 diabetes who are under primary care within the healthcare system and have seen their provider in the last 24 months. They should not have had kidney function tests (eGFR or UACR) in the past 15 months. People already diagnosed with chronic kidney disease cannot participate.

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

I have been diagnosed with chronic kidney disease.

Treatment Details

Interventions

• IRIS-CKD Screening Program (Behavioural Intervention)

Trial Overview The IRIS-CKD study is testing a screening program to detect chronic kidney disease early in people with type 2 diabetes. Participants will either use a home kit or follow standard lab orders for screening, to see which method improves guideline-recommended CKD screening.

Participant Groups

Group I: (IRIS-CKD Screening Program): Home Kit Active Control 1 Intervention

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 II: (IRIS-CKD Screening Program): Standard Lab Testing Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Boehringer Ingelheim

Industry Sponsor

Trials

2,566

Recruited

16,150,000+