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

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About this study

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.

Condition
Chronic Kidney Disease(CKD), Type 2 DM, Type 2 Diabetes Mellitus (T2DM)
Tested
(IRIS-CKD Management Program): Education, (IRIS-CKD Management Program): GDMT
Sponsor
Duke University

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 12

  • Minimum age: 18 years
  • Study condition: Chronic Kidney Disease(CKD), Type 2 DM, Type 2 Diabetes Mellitus (T2DM)
  • (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 6

  • (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

Where

7 sites, 7 recruiting

University of Michigan

Ann Arbor, Michigan, United States

Recruiting

University of Alabama

Birmingham, Alabama, United States

Recruiting

Essentia Institute of Rural Health

Duluth, Minnesota, United States

Recruiting

Duke University

Durham, North Carolina, United States

Recruiting

Houston Methodist

Houston, Texas, United States

Recruiting

Orlando Health

St. Petersburg, Florida, United States

Recruiting

and 1 more site on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.