IRIS-CKD

Currently Recruiting: Participants

Study Drug/Intervention: Intervention- IRIS-CKD is a Phase IV, implementation science study aimed to improve guideline-recommended screening and treatment for chronic kidney disease (CKD) in diabetes.

Anticipated Sample Size:

• Program 1 (Screening): 750 participants
• Program 2 (Treatment): 420 participants

Study Anticipated End Date: Database lock October 2026

ClinicalTrials.gov ID: 

• Program 1 (Screening): NCT06906627
• Program 2 (Treatment): NCT06906640

Study Objectives

Program 1 (CKD screening) will determine whether a home laboratory kit influences CKD screening relative to a standard laboratory order. We will use opportunity score for CKD screening to compare concordance with screening guidelines during the study period. (All virtual)
   
Program 2: In Program 2 (CKD treatment), we will compare prescriptions for guideline-directed medical therapy (GDMT) during the study period. To account for variable GDMT requirements, we will use opportunity scores to compare intervention arms. (All virtual)

Inclusion Criteria

Program 1: Adults with type 2 diabetes (T2D)

• Receiving primary care within the healthcare system, a PCP visit within the past 24 months (any PCP provider, including APP).
• Lack of estimated glomerular filtration rate (eGFR) and/or urine albumin-creatinine ratio (UACR) measurement in the prior 15 months within the EHR.

   
Program 2: 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 SGLT2i therapy. For all other eligible patients, GDMT includes ACEi/ARB, SGLT2i, and finerenone, unless contraindications to any of these therapies exist (e.g., hyperkalemia, diabetic ketoacidosis, etc.).

Exclusion Criteria

Program 1

• Chronic kidney disease (CKD) diagnosed by ICD code.

   
Program 2

• 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.

Adults with T2D

Duration of Study Participation

• Program 1: 3 months
• Program 2: 6 months

Study Follow-Up

Program 1

Patients are randomized to home kit versus standard laboratory testing. Participants in the home testing arm will receive a kit delivered to their home with instructions to complete eGFR (fingerstick) and  UACR (urine sample) testing. For participants in the standard laboratory testing arm, a traditional order will be placed into the EHR for eGFR and/or UACR testing, depending on which lab(s) are missing at baseline.

Program 2

Patients are randomized to education vs guided management. Participants will receive targeted educational materials related to their stage of CKD, including recommendations for potential GDMT to discuss with their primary care provider. The management participants in the management group will receive the above targeted education, 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 site PI. Both groups will complete follow-up labs and questions about their care and outcomes at 6 months.

• Duke University, Durham, NC
• Essentia Health, Minnesota
• Baylor, Scott, White Health, Texas
• U. of Michigan, Michigan
• U. of Alabama, Birmingham, Alabama
• Orlando Health, Florida
• Houston Methodist, Texas

Boehringer Ingelheim Pharmaceuticals, Inc. and Lilly USA, LLC Bayer Healthcare Pharmaceuticals, Inc.

PI: Neha Pagidipati, MD, MPH

PL: Gretchen Sanders

Implementation Specialist: Monica Leyva