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

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?

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.

Will I have to stop taking my current medications?

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

Is the IRIS-CKD Screening Program safe for humans?

The research highlights that patients with chronic kidney disease (CKD) are at high risk for adverse safety events, such as medication errors and complications like hypoglycemia (low blood sugar) and hyperkalemia (high potassium levels). These safety concerns are common in CKD, indicating a need for careful monitoring and management to ensure patient safety. ^{1 2 3 4 5}

How is the IRIS-CKD Screening Program treatment different from other treatments for chronic kidney disease in type 2 diabetes?

The IRIS-CKD Screening Program is unique because it focuses on early detection and prevention of chronic kidney disease in people with type 2 diabetes through targeted screening, rather than treating the disease after it has progressed. This approach aims to identify individuals at risk and implement preventive strategies to manage risk factors before significant kidney damage occurs. ^{4 6 7 8 9}

What data supports the effectiveness of the IRIS-CKD Screening Program treatment for chronic kidney disease in type 2 diabetes?

The research highlights the importance of early screening for chronic kidney disease (CKD) in people with type 2 diabetes, as it helps in early detection and management, potentially preventing disease progression. Screening programs like the Kidney Evaluation for You (KEY) have shown success in identifying high-risk individuals and promoting changes in risk-factor management, which suggests that similar approaches could be effective in managing CKD in type 2 diabetes. ^{4 6 7 10 11}

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

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Screening for chronic kidney disease in Australia: a pilot study in the community and workplace. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Establishment and Validation of a Risk Prediction Model for Early Diabetic Kidney Disease Based on a Systematic Review and Meta-Analysis of 20 Cohorts. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Diabetes mellitus in CKD: Kidney Early Evaluation Program (KEEP) and National Health and Nutrition and Examination Survey (NHANES) 1999-2004. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Risk factors and screening for chronic kidney disease. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Risk Prediction Score for Chronic Kidney Disease in Healthy Adults and Adults With Type 2 Diabetes: Systematic Review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Finding a common language for patient safety in CKD. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

CKD as an underrecognized threat to patient safety. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Action plan for determining and monitoring the prevalence of chronic kidney disease. [2020]

10. New Zealand pubmed.ncbi.nlm.nih.gov

A Multifactorial Risk Score System for the Prediction of Diabetic Kidney Disease in Patients with Type 2 Diabetes Mellitus. [2023]

11. Australia pubmed.ncbi.nlm.nih.gov

Chronic kidney disease awareness, screening and prevention: rationale for the design of a public education program. [2014]