Active, not recruitingNCT04960514Updated Aug 13, 2026

Prospective Decision Impact Trial of KidneyIntelX

An observational study in Diabetic Kidney Disease, Chronic Kidney Disease Stage 1 and Chronic Kidney Disease Stage 2, sponsored by Renalytix AI, Inc.. Active, not recruiting at 1 site in United States. Open to participants aged 23 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Renalytix AI, Inc. · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 2,000
Ages: 23 Years and older
Sex: All

Study summary

The current 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 studied

Diabetic Kidney Disease
Chronic Kidney Disease Stage 1
Chronic Kidney Disease Stage 2
Chronic Kidney Disease, Stage 3 (Moderate)

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In context

Diabetic Nephropathies

534 studies on the registry are indexed under Diabetic Nephropathies; 107 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 154 across 142 observational studies indexed under Diabetic Nephropathies.

Browse Diabetic Nephropathies studies →

Lead sponsor

Renalytix AI, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 23 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Patients with Type 2 diabetes and existing chronic kidney disease stages 1-3.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 2,000 participants (estimated)
Patient registry: No

Interventions

Diagnostic testKidneyIntelX
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 researchers measure

Primary outcomes

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).
Time frame: 12 Months
HbA1c
Proportion (target: 20% increase) of patients that achieve individualized target of HbA1c.
Time frame: 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.
Time frame: 12 Months
SGLT2/ GLP1
Proportion (target: 20% increase) of patients recently treated with SGLT2 inhibitors or GLP1 agonists.
Time frame: 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.
Time frame: 12 Months
Referrals
Proportion (target: 20% increase) of patients referred/managed by a dietician, diabetologist, or nephrologist.
Time frame: 12 Months

Study locations

1 site

Atrium Health Wake Forest Baptist - Family Medicine - Piedmont Plaza
Winston-Salem, North Carolina 27104, United States

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04960514
Lead sponsor: Renalytix AI, Inc.
Responsible party: Sponsor
First posted: Jul 14, 2021
Start date: Nov 22, 2021
Primary completion: Dec 1, 2023
Completion: Dec 1, 2026 (estimated)
Last update: Aug 13, 2026

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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