mGFR vs tGFR in AKI

The goal of this study is to learn if the TGFR device (which uses telmapirazin to continuously measure real-time GFR) works to provide accurate and dynamic kidney function assessment in critically ill adults with acute kidney injury (AKI). It will also learn how tGFR compares with the gold standard measured GFR (mGFR) and other commonly used estimate methods. The main questions it aims to answer are:

* Does tGFR show good agreement with mGFR over the 0-12 hour period in AKI patients? * How do tGFR, mGFR, 4-hour creatinine clearance, kinetic GFR (keGFR), and CKD-EPI eGFR compare across different AKI stages? * What are the bias and variability of each method over time?

Researchers will compare tGFR to mGFR (iohexol clearance) to see if tGFR is a reliable alternative for bedside, continuous GFR monitoring. They will also compare tGFR against 4-hour creatinine clearance, keGFR, and eGFR to assess consistency across AKI stages.

Participants will:

* Wear a single-use tGFR sensor patch on the chest for continuous GFR monitoring * Receive iohexol injection for mGFR measurement (gold standard) * Provide blood and urine samples for 4-hour creatinine clearance and other tests * Undergo repeated GFR assessments over the 12-hour study period

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Key information

Conditions

AKI Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications GFR Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

CU stay ≤ 72 hours;
meets KDIGO AKI criteria;
age 18-85 years;
able to complete blood/urine collection and monitoring

Exclusion criteria

prior history of CKD stage 4 or higher;
anuria;
recent contrast agent exposure or kidney transplant history;
pregnancy or breastfeeding; expected survival < 24 hours.

Treatment and study plan

transdermal GFR

Device

The tGFR detection system comprised 3 distinct components as follows: (i) the fluorescent tracer agent, Lumitrace, (ii) a single small module containing both the light source and photo detector attached to the upper chest area using a biocompatible adhesive, and (iii) a display monitor that digitizes the acquired fluorescent intensity data and contains the algorithms to convert these data to GFR. Background endogenous fluorescence was acquired after attachment of the module to the chest, followed by a 7 ml i.v. bolus dose of Lumitrace. The monitor shows the fluorescence intensity as it is being acquired and then displays the determined tGFR after data acquisition is completed.

Primary outcomes

To validate the agreement of TGFR with mGFR in AKI patients at both the segmented and overall 0-12 hour levels.

Time frame: 12 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Bin Du

CONTACT

[email protected]

86+69155643

Sponsors and collaborators

Lead sponsor

Bin Du

Other

Registry information

Official study title

Comparison of Agreement Between mGFR and tGFR in ICU Patients With Acute Kidney Injury

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Jun 8, 2026
Registry last updated: Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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