NCT06906640

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Oct 2025

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Oct 2025Apr 2027

First Submitted

Initial submission to the registry

February 21, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

October 28, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

February 21, 2025

Last Update Submit

April 6, 2026

Conditions

Type 2 DMChronic Kidney Disease(CKD)Type 2 Diabetes Mellitus (T2DM)

Keywords

CKDT2DMT2DType 2 DiabetesChronic kidney disease

Outcome Measures

Primary Outcomes (1)

  • CKD GDMT Opportunity Score at 6 months

    Opportunity score of GDMT prescriptions at 6 months that were missing at baseline. The score will include prescriptions for GDMT that are active at month 6 or the loss of an indication for the GDMT.

    6 months

Secondary Outcomes (2)

  • CKD GDMT Opportunity Score at 6 months weighted by dose

    6 months

  • CKD GDMT Opportunity Score at 3 months

    3 months

Other Outcomes (1)

  • UACR change

    6 months

Study Arms (2)

(IRIS-CKD Management Program): Education

ACTIVE COMPARATOR

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.

Other: (IRIS-CKD Management Program): Education

(IRIS-CKD Management Program): GDMT

ACTIVE COMPARATOR

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.

Other: (IRIS-CKD Management Program): EducationOther: (IRIS-CKD Management Program): GDMT

Interventions

(IRIS-CKD Management Program): EducationOTHER

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): Education(IRIS-CKD Management Program): GDMT
(IRIS-CKD Management Program): GDMTOTHER

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.

(IRIS-CKD Management Program): GDMT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.).

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Alabama

Birmingham, Alabama, 35233, United States

RECRUITING

Orlando Health

St. Petersburg, Florida, 33701, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Essentia Institute of Rural Health

Duluth, Minnesota, 55805, United States

RECRUITING

Duke University

Durham, North Carolina, 27707, United States

RECRUITING

Baylor Scott & White

Temple, Texas, 76508, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, ChronicDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Neha Pagidipati, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gretchen Sanders, MSN

CONTACT

919 6687829gretchen.sanders@duke.edu

Monica Leyva, MS

CONTACT

monica.leyva@duke.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: (IRIS-CKD Management Program) is a comparative effectiveness 1:1 randomized trial of two interventions (Management vs. Education) to improve implementation of GDMT for CKD in 420 patients with T2D. All potential participants will receive educational materials on importance and opportunities to treat CKD before randomization. After randomization, both Education and Management participants will receive targeted educational materials on CKD and GDMT. The primary outcome will be an opportunity score of CKD GDMT at 6 months based on prescriptions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2025

First Posted

April 2, 2025

Study Start

October 28, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(6)