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Blood test could predict who faces rapid kidney decline in diabetes

NCT ID NCT05198284

Diagnosis Sponsor: Renalytix AI, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial tests whether a blood-based test called KidneyIntelX can help doctors better manage patients with type 2 diabetes and early-stage chronic kidney disease. The test estimates the risk of rapid kidney function decline over five years. Researchers will see if using this test leads to more patients hitting treatment targets—like blood pressure, blood sugar, and protective medications—and whether it improves kidney health. The study includes 2,000 adults with type 2 diabetes and mild to moderate kidney impairment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KidneyIntelX, a blood-based diagnostic test that estimates the risk of rapid kidney function decline in people with type 2 diabetes and chronic kidney disease.
What this could lead to
If effective, this test could help doctors identify high-risk patients earlier and tailor treatments to slow kidney damage, potentially preventing or delaying kidney failure.
What could go wrong
The trial is large but still early in assessing real-world impact. The test may not consistently change doctor decisions or improve patient outcomes, and results may vary across diverse populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

23 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * 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.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome diabetic kidney disease type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease stage 1 Chronic kidney disease stage 2 Chronic kidney disease stage 3 Chronic kidney diseases Diabetic kidney disease

Contacts and locations

Locations

  • Mount Sinai Health System

    New York, New York, 10029, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.