Screening Program for Chronic Kidney Disease in Type 2 Diabetes

(IRIS-CKD Trial)

Recruiting at 6 trial locations

Overseen By Gretchen Sanders, MSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Chronic kidney disease

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how doctors check for chronic kidney disease (CKD) in people with type 2 diabetes (T2D). It compares two methods: sending a home test kit or using standard lab tests. The home kit includes a fingerstick and urine sample test, while the standard method involves regular lab tests ordered by doctors. Suitable participants have type 2 diabetes, have seen their primary care doctor in the last two years, and haven't had certain kidney tests in the last 15 months. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance CKD detection methods for T2D patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the IRIS-CKD Screening Program is safe for individuals with type 2 diabetes?

Research has shown that using home kits to check for chronic kidney disease (CKD) in people with type 2 diabetes is generally safe. This process involves taking a small blood sample with a fingerstick and a urine sample. These methods are simple and commonly used in regular health check-ups to assess kidney function.

No reports of serious side effects or risks have emerged from these tests. Most individuals experience only minor discomfort, such as a small prick from the fingerstick. The screening aims to detect kidney problems early, which is crucial for managing health in type 2 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IRIS-CKD Screening Program because it introduces innovative ways to screen for chronic kidney disease in individuals with type 2 diabetes. Unlike traditional methods that rely solely on standard lab testing, this program offers a home kit that allows participants to conduct essential tests like eGFR and UACR from the comfort of their homes. This new approach could make screening more accessible and convenient, potentially leading to earlier detection and better management of kidney disease. By providing both home-based and standard lab testing options, the program aims to identify the most effective and user-friendly screening method.

What evidence suggests that the IRIS-CKD Screening Program is effective for improving CKD screening in individuals with type 2 diabetes?

Studies have shown that better screening for chronic kidney disease (CKD) in people with type 2 diabetes (T2D) can lead to improved health. The IRIS-CKD program, which includes participants in this trial, aims to simplify CKD screening for these patients. This trial features two arms: one uses home test kits for key markers, such as eGFR (a test for kidney function) and UACR (a urine test for kidney damage), while the other uses standard laboratory testing. Research suggests that home test kits can increase screening rates. This method builds on proven screening techniques that have succeeded in other groups. Better screening can help detect CKD earlier, which is crucial for more effective management of the condition. ^{1 2 3 4 6}

Who Is on the Research Team?

Neha Pagidipati, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

CKD Screening

Participants are randomized to receive either a home kit or a standard laboratory order for CKD screening

3 months

Follow-up

Participants are monitored for completion of CKD screening and outcome measures

3 months

What Are the Treatments Tested in This Trial?

Interventions

• IRIS-CKD Screening Program

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

Chronic kidney disease (CKD) that does not require dialysis significantly increases the risk of adverse safety events, which can lead to poor patient outcomes, highlighting the need for better safety measures in CKD care.

Medication errors are prevalent in CKD patients and contribute to safety lapses, indicating that a standardized set of disease-specific safety indicators is essential for improving patient safety and outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding a common language for patient safety in CKD. Fink, JC., Joy, MS., St Peter, WL., et al.[2019]

Chronic kidney disease (CKD) is often underrecognized in healthcare, making it a high-risk condition for safety events that can worsen kidney function and lead to end-stage renal disease.

Improving recognition of CKD and implementing disease-specific safety indicators could help reduce adverse safety events and slow the progression of kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CKD as an underrecognized threat to patient safety. Fink, JC., Brown, J., Hsu, VD., et al.[2023]

In a study of 267 predialysis patients with chronic kidney disease (CKD), 69.3% experienced at least one adverse safety event, highlighting the high risk of complications in this population.

The most common adverse events reported were hypoglycemia in diabetic patients and hyperkalemia (high potassium levels), with significant co-occurrences of these events, indicating a need for better safety monitoring in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. Ginsberg, JS., Zhan, M., Diamantidis, CJ., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06906640

Study Details | NCT06906640 | Implementation pRogram ... 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. pcornet.org pcornet.org/news/studies-implementation-program-to-improve-screening-and-management-for-ckd-in-diabetes-iris-ckd/

Implementation Program to Improve Screening and ... IRIS-CKD is a project focused on improving how doctors check for and treat chronic kidney disease (CKD) in people with type 2 diabetes (T2D).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06906627?cond=Diabetes

Implementation pRogram to Improve Screening and ... 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 ...

4. withpower.com withpower.com/trial/phase-renal-insufficiency-chronic-3-2025-4b0d3

Management Program for Chronic Kidney Disease in Type ... The IRIS-CKD Management Program may be effective because similar pharmacist-led programs have shown success in improving diabetes and kidney health by helping ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8987693/

Performance of Diabetes and Kidney Disease Screening ... Four easy-to-use screening scores for DM and CKD are well-validated in contemporary United States and Korean populations.

6. cardiohealthalliance.org cardiohealthalliance.org/news/iris-ckd-aims-to-improve-diagnosis-and-treatment-for-chronic-kidney-disease/

IRIS-CKD Aims to Improve Diagnosis and Treatment ... The CardioHealth Alliance to improve diagnosis and treatment for chronic kidney disease (CKD) in patients with Type 2 diabetes mellitus (T2DM).