Chronic Kidney DiseasesNCT04802395
Real World Evidence Clinical Utility Study of KidneyIntelX
An observational study of Chronic Kidney Diseases and Diabetic Kidney Disease, run by Renalytix AI, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the impact of the KidneyIntelX assay utilized as part of the current standard of care on the management of patients seen in the primary care physician's office at Mount Sinai. Read more about this study
- Who is it for?
- Ages 23 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Diabetic Kidney Disease
- What is being tested?
- KidneyIntelX
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2021to 1 Dec 2026
- Phase
- Observational
- 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 23 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Type 2 diabetes and existing chronic kidney disease stages 1-3.
Who may be able to join
- Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging.
Who cannot join
- Patents without the appropriate characteristics as identified in the KidneyIntelX intended use population.
- Patients with eGFR <30 or ≥ 60 ml/min/1.73m2 without albuminuria.
- Patients with ESRD or on renal recovery treatments at time of enrollment.
- Patients who are pregnant at the time of enrollment.
- Patients who are currently hospitalized.
- Patients without minimum 6 month pre-baseline KidneyIntelX medical history.
- Patients who are currently on Enbrel.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Health System
New York, New York, 10029
About this study
Official title: Real World Evidence Clinical Utility Study of KidneyIntelX in Patients With Type 2 Diabetes and Chronic Kidney Disease
The purpose of this study is to assess the impact of the KidneyIntelX assay utilized as part of the current standard of care on the management of patients seen in the primary care physician's office at Mount Sinai.
- Conditions
- Chronic Kidney Diseases, Diabetic Kidney Disease
- Being tested
- KidneyIntelX
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KidneyIntelXDiagnostic test
KidneyIntelX is an in-vitro diagnostic that enables accurate risk prediction of progressive decline in kidney function in patients with type 2 diabetes and existing CKD at stages 1-3 (eGFR of 30 to 59 ml/min/1.73m2, or eGFR ≥ 60 ml/min/1.73m2 and uACR ≥ 30 mg/g).
What is being measured
The primary outcome is the main question the study is designed to answer.
Referrals
Proportion (target: 20%) of patients referred to a dietician, diabetologist, or nephrologist.
Measured: 6 Months
Statins and or ACEi/ARB
Proportion (target: 20% increase) of patients treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.
Measured: 6 Months
HbA1c
Proportion (target: 20% increase) of patients to receive information and or advice on their individualized target of HbA1c.
Measured: 6 Months
SGLT2/ GLP1
Proportion (target: 20% increase) of patients treated with SGLT2 inhibitors or GLP1 agonists.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start2 Mar 2021
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renalytix AI, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mount Sinai Hospital, New York
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802395
- Sponsor's protocol ID
- RAI 19-1004
- Status last verified
- Aug 2026
- First submitted
- 12 Mar 2021
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evidence Clinical Utility Study of KidneyIntelX in Patients With Type 2 Diabetes and Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04802395
- Acronym / sponsor ID
- RAI 19-1004
- Conditions
- Chronic Kidney Diseases, Diabetic Kidney Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Renalytix AI, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mount Sinai Hospital, New York
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Mar 2021 (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.
The purpose of this study is to assess the impact of the KidneyIntelX assay utilized as part of the current standard of care on the management of patients seen in the primary care physician's office at Mount Sinai.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 23 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Type 2 diabetes and existing chronic kidney disease stages 1-3.
Key inclusion criteria (1 listed)
- Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging.
Key exclusion criteria (7 listed)
- Patents without the appropriate characteristics as identified in the KidneyIntelX intended use population.
- Patients with eGFR <30 or ≥ 60 ml/min/1.73m2 without albuminuria.
- Patients with ESRD or on renal recovery treatments at time of enrollment.
- Patients who are pregnant at the time of enrollment.
- Patients who are currently hospitalized.
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 |
|---|---|---|
| KidneyIntelXKidneyIntelX is an in-vitro diagnostic that enables accurate risk prediction of progressive decline in kidney function in patients with type 2 diabetes and existing CKD at stages 1-3 (eGFR of 30 to 59 ml/min/1.73m2, or eGFR ≥ 60 ml/min/1.73m2 and uACR ≥ 30 mg/g). | Diagnostic test | – |
Primary outcome
Referrals
Time frame: 6 Months
Proportion (target: 20%) of patients referred to a dietician, diabetologist, or nephrologist.
Statins and or ACEi/ARB
Time frame: 6 Months
Proportion (target: 20% increase) of patients treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.
HbA1c
Time frame: 6 Months
Proportion (target: 20% increase) of patients to receive information and or advice on their individualized target of HbA1c.
SGLT2/ GLP1
Time frame: 6 Months
Proportion (target: 20% increase) of patients treated with SGLT2 inhibitors or GLP1 agonists.
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 13 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Diabetic Kidney Disease, run by Renalytix AI, Inc. at 1 site 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 1 inclusion and 7 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Roger Tun (646-397-3970 ext. 106, rtun@renalytix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Referrals (time frame: 6 Months). The study lists 4 primary outcomes in all. 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 13 Aug 2026.