Chronic Kidney Disease(CKD)IRIS-CKDNCT06906640
Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD) (Program 2)
A study testing (IRIS-CKD Management Program): Education and (IRIS-CKD Management Program): GDMT in people with Chronic Kidney Disease(CKD) and Type 2 DM, run by Duke University at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease(CKD), Type 2 DM, Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- (IRIS-CKD Management Program): Education and (IRIS-CKD Management Program): GDMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 7 sitesUnited States
- Study dates
- 28 Oct 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.).
Who cannot join
- (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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
lisa monk, MSN contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Angie Westover, 734-936-6467, funke@med.umich.edu
Ilka Decker, MD
- Recruiting
University of Alabama
Birmingham, Alabama, 35233
Sarah Machado, 205-934-7649, smachado@uabmc.edu
Clare Lyas, MD
- Recruiting
Essentia Institute of Rural Health
Duluth, Minnesota, 55805
Haley Messenger, 218.786.2077, haley.messenger@essentiahealth.org
Sreedhar Devathi, MD
- Recruiting
Duke University
Durham, North Carolina, 27707
Kim Cicio, kimberly.cicio@duke.edu
John Middleton, MD
- Recruiting
Houston Methodist
Houston, Texas, 77030
Daphne Medina, 713-744-2016, damedina2@houstonmethodist.org
Steven Puckett, srpuckitt@houstonmethodist.org
- Recruiting
Orlando Health
St. Petersburg, Florida, 33701
Timothy Marsh, DO
- Recruiting
Baylor Scott & White
Temple, Texas, 76508
Tariq Tariq, MD
About this study
Official title: Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 2) (IRIS-CKD)
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.
Read the detailed description
IRIS-CKD Management Program: will compare prescriptions for guideline-directed medical therapies (GDMT) during the study period. To account for variable GDMT requirements, we will use opportunity scores to compare intervention arms. Patients will be screened, identified and undergo consent by the study site. Patients will receive educational materials related to CKD screening in T2D and details regarding the testing intervention study as per site specific recruitment requirements. The primary objective is to determine whether implementing a guided management program versus education alone will improve prescription of GDMT for people with CKD and T2D. Patients will complete approximately 6 months of follow-up.
- Being tested
- (IRIS-CKD Management Program): Education, (IRIS-CKD Management Program): GDMT
- Keywords
- CKD, T2DM, T2D, Type 2 Diabetes, Chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(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): 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.
| Study group | Role | What they receive |
|---|---|---|
| (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. Receives: 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. Receives: Other: (IRIS-CKD Management Program): Education; Other: (IRIS-CKD Management Program): GDMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
CKD GDMT Opportunity Score at 6 months weighted by dose
Change in opportunity score from baseline to 6 months weighted by prescribed dose of GDMT.
Measured: 6 months
CKD GDMT Opportunity Score at 3 months
Opportunity score of GDMT prescriptions at 3 months that were missing at baseline.
The score will include prescriptions for GDMT that are active at month 3 or the loss of an indication for the GDMT.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start28 Oct 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease(CKD)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- (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.
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Neha Pagidipati, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906640
- Sponsor's protocol ID
- Pro00116493_1
- Acronym
- IRIS-CKD
- Status last verified
- Apr 2026
- First submitted
- 21 Feb 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 2) (IRIS-CKD)
- ClinicalTrials.gov ID
- NCT06906640
- Acronym / sponsor ID
- IRIS-CKD / Pro00116493_1
- Keywords
- CKD, T2DM, T2D, Type 2 Diabetes, Chronic kidney disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Bayer, Boehringer Ingelheim
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
IRIS-CKD Management Program: will compare prescriptions for guideline-directed medical therapies (GDMT) during the study period. To account for variable GDMT requirements, we will use opportunity scores to compare intervention arms. Patients will be screened, identified and undergo consent by the study site. Patients will receive educational materials related to CKD screening in T2D and details regarding the testing intervention study as per site specific recruitment requirements. The primary objective is to determine whether implementing a guided management program versus education alone will improve prescription of GDMT for people with CKD and T2D. Patients will complete approximately 6 months of follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- (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.
| Arm | Type | Receives |
|---|---|---|
| (IRIS-CKD Management Program): Education | Active comparator | Other: (IRIS-CKD Management Program): EducationEducation: Participants will receive targeted educational materials related to their stage of CKD, including recommendations for potential GDMT to discuss with their primary care provider. |
| (IRIS-CKD Management Program): GDMT | Active comparator | Other: (IRIS-CKD Management Program): Education, Other: (IRIS-CKD Management Program): GDMTManagement: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- (CKD Management)
Key exclusion criteria (6 listed)
- (CKD Management)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (IRIS-CKD Management Program): EducationPatients 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. | Other | (IRIS-CKD Management Program): Education, (IRIS-CKD Management Program): GDMT |
| (IRIS-CKD Management Program): GDMTPatients 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. | Other | (IRIS-CKD Management Program): GDMT |
Primary outcome
CKD GDMT Opportunity Score at 6 months
Time frame: 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.
2 secondary outcomes
CKD GDMT Opportunity Score at 6 months weighted by dose
Time frame: 6 months
CKD GDMT Opportunity Score at 3 months
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
lisa monk, MSN contact
Neha Pagidipati, MD principal investigator
Duke University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (IRIS-CKD Management Program): Education and (IRIS-CKD Management Program): GDMT in people with Chronic Kidney Disease(CKD) and Type 2 DM, run by Duke University at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gretchen Sanders, MSN (919 6687829, gretchen.sanders@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CKD GDMT Opportunity Score at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.