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KidneyIntelX Study for Chronic Kidney Disease and Diabetic Kidney Disease

This study is looking at how a diagnostic test called KidneyIntelX impacts the care of patients with chronic kidney disease (CKD) and diabetic kidney disease. KidneyIntelX helps predict how kidney function might change in people with type 2 diabetes and CKD stages 1-3. The study will assess if using KidneyIntelX leads to changes in referrals to specialists, the use of certain medications like statins or ACE inhibitors/ARBs (angiotensin-converting enzyme inhibitors/angiotensin receptor blockers), and blood sugar control (HbA1c) over 6 months. You might be able to join if you have type 2 diabetes and certain stages of CKD. The study aims to enroll 10,000 participants and is currently unclear on its recruitment status.

Study design
This is an observational study, meaning researchers will watch how patients are cared for when KidneyIntelX is used as part of their regular treatment. It aims to include 10,000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes like referrals, medication use, and HbA1c at 6 months, suggesting a follow-up period of at least 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04802395

Real World Evidence Clinical Utility Study of KidneyIntelX

Recruiting
Not specifiedAges 23+Observational
Renalytix AI, Inc.
~10,000 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:KidneyIntelX

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Referrals
Measured over 6 Months
+3 more outcomes measured

Conditions

Chronic Kidney Diseases
Diabetic Kidney Disease

Explore related trials

Chronic Kidney DiseaseDiabetic Nephropathy

Where it's being run

1 sites across 1 states
New York1

Who to contact

Roger Tun
[email protected]
646-397-3970 · ext. 106
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging.

Exclusion

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.

What this trial measures

  • Referrals6 Months

    Proportion (target: 20%) of patients referred to a dietician, diabetologist, or nephrologist.

  • Statins and or ACEi/ARB6 Months

    Proportion (target: 20% increase) of patients treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.

  • HbA1c6 Months

    Proportion (target: 20% increase) of patients to receive information and or advice on their individualized target of HbA1c.

  • SGLT2/ GLP16 Months

    Proportion (target: 20% increase) of patients treated with SGLT2 inhibitors or GLP1 agonists.