Management Program for Chronic Kidney Disease in Type 2 Diabetes

(IRIS-CKD Trial)

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

1170 Participants Needed

Trial Summary

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

The IRIS-CKD Management Program may be effective because similar pharmacist-led programs have shown success in improving diabetes and kidney health by helping patients better manage their medications and reach health goals like lower blood sugar and blood pressure. ^{1 2 3 4 5}

Is the Management Program for Chronic Kidney Disease in Type 2 Diabetes safe for humans?

The combination of dipeptidyl peptidase-4 inhibitors and insulin in patients with type 2 diabetes and chronic kidney disease has been shown to manage glucose levels without increasing adverse events. Additionally, SGLT2 inhibitors have been found to have a favorable safety profile in diabetic patients with advanced chronic kidney disease. ^{6 7 8 9 10}

What makes the IRIS-CKD Management Program treatment unique for chronic kidney disease in type 2 diabetes?

The IRIS-CKD Management Program is unique because it focuses on improving medication adherence through an interprofessional approach, involving pharmacists and other healthcare providers, to support patients with diabetic kidney disease. This structured program aims to enhance self-management and adherence to complex medication regimens, which is crucial for better long-term outcomes. ^{1 3 11 12 13}

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

Exclusion Criteria

I have Type 1 diabetes.

My kidney function is very low.

I have had a kidney transplant.

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Interprofessional Medication Adherence Program for Patients With Diabetic Kidney Disease: Protocol for a Randomized Controlled and Qualitative Study (PANDIA-IRIS). [2021]

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

Chronic kidney disease risk reduction in a Hispanic population through pharmacist-based disease-state management. [2021]

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

The impact of an integrated diabetes and kidney service on patients, primary and specialist health professionals in Australia: A qualitative study. [2023]

4. England 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. [2022]

5. Iran pubmed.ncbi.nlm.nih.gov

The Compatibility of the Treatment Modalities to the Recommendations of the Kidney Disease Outcomes Quality Initiative Guideline in Chronic Kidney Disease Patients with Diabetes. [2022]

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

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

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

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

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

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

9. Japan pubmed.ncbi.nlm.nih.gov

Dipeptidyl peptidase-4 inhibitor and insulin combination treatment in type 2 diabetes and chronic kidney disease: A meta-analysis. [2022]

10. Ireland 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. [2023]

11. Mexico pubmed.ncbi.nlm.nih.gov

Prevalence and risk factors of chronic kidney disease in the comprehensive care program DiabetIMSS [2018]

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

Effects of structured care by a pharmacist-diabetes specialist team in patients with type 2 diabetic nephropathy. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

[Diabetic nephropathy: Interprofessional support of medication adherence]. [2023]