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Could a simple fingerstick test replace lab visits for kidney patients?

NCT ID NCT07251075

Diagnosis Sponsor: Tingting Xu 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will test a new handheld device that measures creatinine (a kidney health marker) from a fingerstick blood sample at home. Researchers will compare its accuracy to standard lab tests and ask 200 adults with kidney disease to try the device and rate how easy it is to use. The goal is to see if this device can help people monitor their kidney function conveniently and reliably without going to a clinic.

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 reliable, easy-to-use home test for people with kidney disease to monitor their kidney function without frequent clinic visits.
What could go wrong
This is an early-stage accuracy and usability study with only 200 participants. The device may not be as accurate as lab tests, or users may find it difficult to use correctly at home.

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 200 people

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

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Dec 2025

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

Include at least 80% patients with varying stages of non-dialysis dependent kidney disease, as well as a small group (e.g.\<20 %) of healthy volunteers and dialysis-dependent kidney disease patients, to cover the reference interval of the creatinine concentration. All subjects should be naive to this creatinine monitoring system and the similar self-monitoring devices (including but not limited to glucose, ketone, total cholesterol, etc.).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Abnormal creatinine levels or suspected kidney disease; * Aged 18 and above, gender is not limited; * Voluntarily participate in this clinical study by signing the informed consent form. Exclusion Criteria: * The HCT range is not within 25-65%; * Severe mental illness or other conditions that make the patient unable to cooperate; * Inability to read or write in English language; * Incomplete subject information (including but not limited to gender, age, education level, clinical diagnosis information; etc.); * Previous experience with this creatinine monitoring system or similar self-monitoring devices (including but not limited to those for glucose, ketones, total cholesterol, etc.); * Other conditions that, in the opinion of the investigator, make participation in this clinical trial inappropriate.

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Conditions

The condition(s) this trial relates to.

acute kidney injury chronic kidney disease chronic renal failure syndrome

As listed by the trial registrant

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

Chronic kidney diseases Kidney injury, acute

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

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