Chronic Kidney Disease(CKD)IRIS-CKDNCT06906627
Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 1) (IRIS-CKD)
A study testing (IRIS-CKD Screening Program): Home Kit and (IRIS-CKD Screening Program): Standard Lab Order 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 an implementation study to improve guideline-recommended screening 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 Screening Program): Home Kit and (IRIS-CKD Screening Program): Standard Lab Order
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 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
- Adults with type 2 diabetes (T2D)
- Receiving primary care within the healthcare system, Primary Care Provider (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
Who cannot join
- Chronic kidney disease (CKD) diagnosis
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
- Recruiting
University of Alabama
Birmingham, Alabama, 35233
Sarah Machado, smachado@uabmc.edu
Clare Lyas, MD
- Recruiting
Essentia Health
Duluth, Minnesota, 55805
Haley Messenger, 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, North Carolina, 77030
Daphne Medina
Steven Puckett, srpuckitt@houstonmethodist.org
- Recruiting
Orlando Health
St. Petersburg, Florida, 33701
Timothy Marsh, DO
- Recruiting
Baylor Scott & White
Temple, Texas, 76508
Tariq Shafi, MD
About this study
Official title: Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD)
IRIS-CKD is an implementation study to improve guideline-recommended screening of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.
Read the detailed description
IRIS-CKD Screening Program: will focus on CKD screening in T2D. We will identify patients with T2D that have not received appropriate screening for CKD within the last 15 months and randomize patients to receive either a home kit to complete CKD screening ("home kit") versus a standard laboratory order ("laboratory order"). The primary objective is to evaluate whether delivery of home testing kits versus standard laboratory testing influences the degree to which patients receive guideline-recommended CKD screening. Patients will complete approximately 3 months of follow-up.
- Being tested
- (IRIS-CKD Screening Program): Home Kit, (IRIS-CKD Screening Program): Standard Lab Order
- 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 Screening Program): Home KitOther
All participants approached for enrollment in Program 1 will receive National Kidney Foundational educational materials related to CKD screening in type 2 diabetes and study information. All enrolled participants will receive a message regarding study lab(s) results.
Home Test Kit: a kit delivered to participants homes with instructions to complete eGFR (fingerstick) and/or UACR (urine sample) testing, depending on which lab(s) are missing at baseline.
(IRIS-CKD Screening Program): Standard Lab OrderOther
ll participants approached for enrollment in Program 1 will receive National Kidney Foundation educational materials related to CKD screening in type 2 diabetes and study information. All enrolled participants will receive a message regarding study lab
| Study group | Role | What they receive |
|---|---|---|
| (IRIS-CKD Screening Program): Home Kit | Active comparator | Home Kit: a kit delivered to participants home with instructions to complete eGFR (fingerstick) and/or UACR (urine sample) testing, depending on which lab(s) are missing at baseline. Receives: Other: (IRIS-CKD Screening Program): Home Kit |
| (IRIS-CKD Screening Program): Standard Lab Testing | Active comparator | Standard Laboratory Testing: a traditional order will be placed into the Electronic Health Record (EHR) for eGFR and/or UACR testing, depending on which lab(s) are missing at baseline. Receives: Other: (IRIS-CKD Screening Program): Standard Lab Order |
What is being measured
The primary outcome is the main question the study is designed to answer.
CKD Screening Lab Opportunity Score
Opportunity score of completion of missing guideline-recommended screening for CKD (eGFR and/or UACR) at 3 months.
The opportunity score will be calculated as the ratio of the number of missing labs measured by month 3 divided by the number of missing labs at baseline.
Measured: 3 months
Secondary outcomes (1)
CKD Screening Lab Opportunity Score by Subgroup
Opportunity score across subgroups by missing baseline screening labs: UACR only, eGFR only, or both.
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 Screening Program) is a randomized trial of delivery of a home testing kit for eGFR and/or UACR versus a standard laboratory order to increase rates of CKD screening in people who have lapsed beyond the recommended screening interval.
- Masking
- None (open label)
- Enrolment
- 500 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
- NCT06906627
- Sponsor's protocol ID
- Pro00116493
- 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 (IRIS-CKD)
- ClinicalTrials.gov ID
- NCT06906627
- Acronym / sponsor ID
- IRIS-CKD / Pro00116493
- Keywords
- CKD, T2DM, T2D, Type 2 Diabetes, Chronic kidney disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 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 an implementation study to improve guideline-recommended screening of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.
Detailed description
IRIS-CKD Screening Program: will focus on CKD screening in T2D. We will identify patients with T2D that have not received appropriate screening for CKD within the last 15 months and randomize patients to receive either a home kit to complete CKD screening ("home kit") versus a standard laboratory order ("laboratory order"). The primary objective is to evaluate whether delivery of home testing kits versus standard laboratory testing influences the degree to which patients receive guideline-recommended CKD screening. Patients will complete approximately 3 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 Screening Program) is a randomized trial of delivery of a home testing kit for eGFR and/or UACR versus a standard laboratory order to increase rates of CKD screening in people who have lapsed beyond the recommended screening interval.
| Arm | Type | Receives |
|---|---|---|
| (IRIS-CKD Screening Program): Home Kit | Active comparator | Other: (IRIS-CKD Screening Program): Home KitHome Kit: a kit delivered to participants home with instructions to complete eGFR (fingerstick) and/or UACR (urine sample) testing, depending on which lab(s) are missing at baseline. |
| (IRIS-CKD Screening Program): Standard Lab Testing | Active comparator | Other: (IRIS-CKD Screening Program): Standard Lab OrderStandard Laboratory Testing: a traditional order will be placed into the Electronic Health Record (EHR) for eGFR and/or UACR testing, depending on which lab(s) are missing at baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults with type 2 diabetes (T2D)
- Receiving primary care within the healthcare system, Primary Care Provider (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
Key exclusion criteria (1 listed)
- Chronic kidney disease (CKD) diagnosis
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 Screening Program): Home KitAll participants approached for enrollment in Program 1 will receive National Kidney Foundational educational materials related to CKD screening in type 2 diabetes and study information. All enrolled participants will receive a message regarding study lab(s) results. Home Test Kit: a kit delivered to participants homes with instructions to complete eGFR (fingerstick) and/or UACR (urine sample) testing, depending on which lab(s) are missing at baseline. | Other | (IRIS-CKD Screening Program): Home Kit |
| (IRIS-CKD Screening Program): Standard Lab Orderll participants approached for enrollment in Program 1 will receive National Kidney Foundation educational materials related to CKD screening in type 2 diabetes and study information. All enrolled participants will receive a message regarding study lab | Other | (IRIS-CKD Screening Program): Standard Lab Testing |
Primary outcome
CKD Screening Lab Opportunity Score
Time frame: 3 months
Opportunity score of completion of missing guideline-recommended screening for CKD (eGFR and/or UACR) at 3 months. The opportunity score will be calculated as the ratio of the number of missing labs measured by month 3 divided by the number of missing labs at baseline.
1 secondary outcome
CKD Screening Lab Opportunity Score by Subgroup
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 Screening Program): Home Kit and (IRIS-CKD Screening Program): Standard Lab Order 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 3 inclusion and 1 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 Screening Lab Opportunity Score (time frame: 3 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.