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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• (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.).

Locations
United States
Alabama
University of Alabama
RECRUITING
Birmingham
Minnesota
Essentia Institute of Rural Health
RECRUITING
Duluth
North Carolina
Duke University
RECRUITING
Durham
Contact Information
Primary
Gretchen Sanders, MSN
gretchen.sanders@duke.edu
919 6687829
Backup
Monica Leyva, MS
monica.leyva@duke.edu
Time Frame
Start Date: 2025-10-28
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 420
Treatments
Active_comparator: (IRIS-CKD Management Program): Education
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.
Active_comparator: (IRIS-CKD Management Program): GDMT
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.
Related Therapeutic Areas
Sponsors
Collaborators: Boehringer Ingelheim, Eli Lilly and Company, Bayer
Leads: Duke University

This content was sourced from clinicaltrials.gov