Recruiting

CKD with T2D

Sponsor:

Duke University

Code:

NCT06906640

Conditions

Chronic Kidney Disease(CKD)

Type 2 DM

Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

(IRIS-CKD Management Program): Education

(IRIS-CKD Management Program): GDMT

Study Details

Brief 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.

Conditions

Chronic Kidney Disease(CKD)

Type 2 DM

Type 2 Diabetes Mellitus (T2DM)

Study ID

NCT06906640

Start date

Oct 28, 2025

Status verified date

Apr, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

(IRIS-CKD Management Program): Education

Patients randomized to the education arm will receive targeted education materials regarding their severity of CKD, including the potential for additional GDMT to slow CKD progression to discuss with their Primary Care Provider (PCP). At 6 months, the study pharmacist (or APP) will order repeat eGFR and UACR after 6 months to standardize CKD follow up during the study period.

(IRIS-CKD Management Program): GDMT

Patients randomized to the education arm will receive targeted education materials regarding their severity of CKD, including the potential for additional GDMT to slow CKD progression to discuss with their PCP. At 6 months, the study pharmacist (or APP) will order repeat eGFR and UACR after 6 months to standardize CKD follow up during the study period. Plus, receive guided care by APP.

Primary outcome measure

  • CKD GDMT Opportunity Score at 6 months [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Gretchen Sanders, MSN

919 6687829gretchen.sanders@duke.edu

Monica Leyva, MS

monica.leyva@duke.edu

Locations

University of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Sarah Machado

205-934-7649smachado@uabmc.edu

Principal Investigator:

Clare Lyas, MD

Orlando Health

Recruiting

St. Petersburg, Florida, United States, 33701

Principal Investigator:

Timothy Marsh, DO

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Angie Westover

734-936-6467funke@med.umich.edu

Principal Investigator:

Ilka Decker, MD

Essentia Institute of Rural Health

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Haley Messenger

218-786-2077haley.messenger@essentiahealth.org

Principal Investigator:

Sreedhar Devathi, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27707

Contacts

Kim Cicio

kimberly.cicio@duke.edu

Principal Investigator:

John Middleton, MD

Houston Methodist

Recruiting

Houston, Texas, United States, 77030

Contacts

Daphne Medina

713-744-2016damedina2@houstonmethodist.org

Steven Puckett

srpuckitt@houstonmethodist.org

Principal Investigator:

Peter Nguyen

Baylor Scott & White

Recruiting

Temple, Texas, United States, 76508

Principal Investigator:

Tariq Tariq, MD

More Information

Sponsor

Duke University

Last update posted

Jun 16, 2026

Last verified

Apr, 2026

Keywords

  • CKD
  • T2DM
  • T2D
  • Type 2 Diabetes
  • Chronic kidney disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-06-16.