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AI model could spare diabetes patients from invasive kidney biopsies

NCT ID NCT07672639

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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)
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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

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study uses machine learning to tell apart diabetic kidney disease from other kidney diseases in people with type 2 diabetes. Researchers analyzed data from over 2,200 patients across 14 medical centers to build a model that uses routine clinical and lab information. The goal is to provide a noninvasive way to diagnose kidney problems, potentially avoiding the need for a kidney biopsy.

What this could mean

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

What this could lead to
If successful, this could provide a noninvasive way to diagnose kidney disease in diabetes patients, reducing the need for risky biopsies.
What could go wrong
This is a retrospective study using existing data, so results may not apply to all populations. The model's accuracy depends on data quality and may not replace biopsy in all cases.

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

2,201 people

The number who actually took part.

Started

Jan 2019

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

The study population consisted of adults aged 18-70 years with type 2 diabetes mellitus who underwent clinically indicated kidney biopsy at 14 medical centers in China. Participants were identified retrospectively from biopsy records between January 2019 and December 2022. Patients with definitive pathological diagnoses of diabetic kidney disease (DKD) or non-diabetic kidney disease (NDKD) and available clinical data were included in model development. An independent cohort of biopsy-confirmed patients enrolled between January 2022 and December 2024 was used for external validation.

Ages

18 to 70 years

Sex

Anyone

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: * Age 18-70 years * Diagnosis of type 2 diabetes mellitus according to ADA criteria * Underwent kidney biopsy * Definitive pathological diagnosis available * Availability of required clinical and laboratory data Exclusion Criteria: * Type 1 diabetes mellitus * Secondary diabetes * Missing key clinical data * Non-diagnostic kidney biopsy * Incomplete pathological information

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Beijing Tongren Hospital

    Beijing, Beijing Municipality, 100730, China

More trials for these conditions

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