ClinConnect ClinConnect Logo
Search / Trial NCT06906640

Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD) (Program 2)

Launched by DUKE UNIVERSITY · Mar 25, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Ckd T2 Dm T2 D Type 2 Diabetes Chronic Kidney Disease

ClinConnect Summary

The IRIS-CKD trial is a study designed to improve how we screen for and manage chronic kidney disease (CKD) in people with type 2 diabetes (T2D) in the United States. The goal is to ensure that individuals with diabetes receive the best possible care for their kidneys, following the latest guidelines. This study will include adults aged 65 to 74 who have type 2 diabetes and evidence of kidney issues based on recent lab tests. To participate, people must be receiving primary care and have specific kidney test results that show they need better treatment.

If you or a loved one might be eligible, you would need to have type 2 diabetes and certain kidney conditions that were tested within the last two years. However, people with type 1 diabetes, very severe kidney issues, or those who have had a kidney transplant cannot join. The trial is not yet recruiting participants, but once it starts, those who take part can expect to receive improved monitoring and treatment options for their kidney health, which could lead to better overall outcomes.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • (CKD Management)
  • Adults with type 2 diabetes (T2D)
  • Receiving primary care within the healthcare system, visit within 24 months (any PCP provider, including APP)
  • * 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
  • Receiving \<100% GDMT at baseline. For patients with UACR \<30 mg/g, GDMT includes sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy. For all other eligible patients, GDMT includes ACEi/ARB, SGLT2i, and Finerenone, unless contraindications for any of these therapies exist (e.g., hyperkalemia, diabetic ketoacidosis, etc.).
  • Exclusion Criteria:
  • (CKD Management)
  • Type 1 diabetes
  • Most recent eGFR \<20 ml/min/1.73 m2
  • Prior kidney transplant
  • Autosomal dominant polycystic kidney disease (ADPKD)
  • Active pregnancy or plans for conception within 1 year

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Neha Pagidipati, MD

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported