Diabetic Kidney DiseaseNCT05198284
Prospective Decision Impact Clinical Utility Trial of KidneyIntelX
An observational study of Diabetic Kidney Disease and Chronic Kidney Diseases, run by Renalytix AI, Inc. at 1 site in United States.
Trial summary
The clinical utility trial is designed to evaluate how the results of KidneyIntelX test / platform impacts on the clinical management of type 2 diabetes patients identified as increased risk for rapid kidney function decline within 5-years. Read more about this study
- Who is it for?
- Ages 23 years and older
- Conditions the study is for
- Diabetic Kidney Disease, Chronic Kidney Diseases, Chronic Kidney Disease Stage 1
- What is being tested?
- KidneyIntelX
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 1 Nov 2026
- Phase
- Observational
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
- 23 years of age or older.
- Clinical history of confirmed type 2 diabetes.
- Evidence of DKD Stages 1-3:
- Baseline eGFR of 30-59 ml/min/1.73m2 (confirmed 3 months apart with at least one value within 1 year prior to enrollment)
- Individuals with eGFR ≥60 ml/min/1.73m2 and albuminuria (UACR ≥30mg/g)
- All patients will have a HbA1c, eGFR, urine albumin and urine creatinine, eGFR, available from within 12 months of enrollment (to be obtained if not clinically available prior).
- The subject must be able to comprehend and sign an approved informed consent form and other applicable study documents.
Who cannot join
- 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 who are currently on Enbrel.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Decision Impact Clinical Utility Trial of KidneyIntelX in Patients With Type 2 Diabetes and Existing Chronic Kidney Disease
The clinical utility trial is designed to evaluate how the results of KidneyIntelX test / platform impacts on the clinical management of type 2 diabetes patients identified as increased risk for rapid kidney function decline within 5-years.
- Conditions
- Diabetic Kidney Disease, Chronic Kidney Diseases, Chronic Kidney Disease Stage 1, Chronic Kidney Disease Stage 2, Chronic Kidney Disease Stage 3
- Being tested
- KidneyIntelX
- Medical subject headings
- Diabetic Nephropathies, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KidneyIntelXDiagnostic test
KidneyIntelX is a blood-based clinical diagnostic tool that assesses the risk of progressive kidney function decline in chronic kidney disease patients with type 2 diabetes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Proportion (target: 20% increase from prior measurements) of visits in which each participant achieves target blood pressure of <140/90 mmHg (as per the NKF CKD management guidelines).
Measured: 12 Months
HbA1c
Proportion (target: 20% increase) of patients that achieve individualized target of HbA1c.
Measured: 12 Months
ACEi/ARB
Proportion (target: 20% increase) of patients recently treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.
Measured: 12 Months
SGLT2/ GLP1
Proportion (target: 20% increase) of patients recently treated with SGLT2 inhibitors or GLP1 agonists.
Measured: 12 Months
Urine albumin to creatinine ratio
In those with baseline albuminuria, proportion (target: 20%) of patients achieving a 30% decrease in their urine albumin to creatinine ratio from averaged pre-enrollment values to average post-enrollment values through 1 year.
Measured: 12 Months
Referrals
Proportion (target: 20% increase) of patients referred/managed by a dietician, diabetologist, or nephrologist.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Nov 2021
- Primary completion1 Dec 2023
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renalytix AI, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David W Lam, MD, Principal investigator, Mount Sinai Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198284
- Sponsor's protocol ID
- RAI 19-1002
- Status last verified
- Aug 2026
- First submitted
- 5 Jan 2022
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided