Management Program for Chronic Kidney Disease in Type 2 Diabetes

(IRIS-CKD Trial)

Recruiting at 2 trial locations

Overseen By Monica Leyva, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: SGLT2i, ACEi/ARB, Finerenone

Disqualifiers: Type 1 diabetes, eGFR <20, kidney transplant, ADPKD, pregnancy

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

420 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance how doctors screen and treat chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D). Participants will receive educational materials about CKD management, and some will also receive personalized treatment plans and medicine adjustments overseen by healthcare professionals as part of the IRIS-CKD Management Program. Individuals with type 2 diabetes who receive regular care and show signs of CKD from recent lab tests might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to advance CKD care for people with type 2 diabetes.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, it mentions that participants should be receiving less than 100% guideline-directed medical therapy (GDMT) at baseline, which includes certain medications unless there are contraindications.

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

Research has shown that the IRIS-CKD Management Program aims to enhance how doctors detect and treat chronic kidney disease (CKD) in people with type 2 diabetes. Rather than introducing a new drug or device, the program emphasizes education and management strategies, indicating its likely safety.

Participants in this study receive educational materials and may receive advice on already approved medications. As the program focuses on optimizing existing treatments and care, it involves no new or untested therapies. This aspect should reassure participants about the program's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IRIS-CKD Management Program because it offers a proactive approach to managing chronic kidney disease (CKD) in people with type 2 diabetes, unlike the usual care which often involves reactive measures. This program stands out by combining education and personalized medication management, empowering patients with knowledge about their condition and providing tailored treatment adjustments guided by a centralized algorithm and overseen by healthcare professionals. This innovative approach aims to optimize patient outcomes by integrating educational resources with precise, data-driven medication management, potentially leading to more effective and timely interventions for CKD progression.

What evidence suggests that the IRIS-CKD Management Program could be effective for chronic kidney disease in type 2 diabetes?

Studies have shown that pharmacist-led programs can improve the health of people with diabetes and chronic kidney disease (CKD). These programs assist by educating patients and managing their medications, emphasizing guideline-recommended treatments that doctors might sometimes overlook. Research indicates that when pharmacists manage treatments, patients often experience better health outcomes, such as improved kidney health and better diabetes control. This trial will test the IRIS-CKD Management Program in two separate arms: one focusing on education and the other on GDMT (Guideline-Directed Medical Therapy) management. The program employs these successful methods to support individuals with both conditions. ^{1 2 6 7 8}

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 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

Exclusion Criteria

I have Type 1 diabetes.

My kidney function is very low.

I have had a kidney transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive educational materials and GDMT prescription, dose titration, and laboratory monitoring as necessary

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• IRIS-CKD Management Program

Trial Overview

The 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.

How Is the Trial Designed?

Group I: (IRIS-CKD Management Program): Education Active Control 1 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): GDMT Active Control 2 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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

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+

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

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]

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) 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 1,450 type 2 diabetic patients with advanced chronic kidney disease (CKD), SGLT2 inhibitors significantly reduced the rates of kidney-related adverse events (7.7% vs. 24.1%) and major adverse cardiovascular events (MACE) (9.6% vs. 15.1%) compared to a control group.

Patients using SGLT2 inhibitors also showed improved kidney function (eGFR increased by 0.4 ml/min/1.73 m²) and better glycemic control (HbA1c decreased by -0.40%), with only a slight increase in urinary tract infections, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SGLT2 inhibitors reduce adverse kidney and cardiovascular events in patients with advanced diabetic kidney disease: A population-based propensity score-matched cohort study. Chan, GC., Ng, JK., Chow, KM., et al.[2023]

A study involving 1486 patients with chronic kidney disease (CKD) showed that participation in CKD care programs led to a slight increase in the overall goal attainment rate from 59.4% to 60.5% over three years, particularly improving management of low-density lipoprotein and glycated hemoglobin levels.

Patients who achieved their treatment goals experienced better preservation of kidney function, as their estimated glomerular filtration rate (eGFR) did not decline, while those with poor goal achievement saw a significant decrease in eGFR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goal attainment and renal outcomes in patients enrolled in the chronic kidney disease care program in Taiwan: a 3-year observational study. Wang, Y., Lee, YT., Lee, WC., et al.[2022]

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