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mGFR vs tGFR in AKI

NCT07632469 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-06-10

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

transdermal GFR

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.

Sponsors & Collaborators

  • Bin Du

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-08
Primary Completion
2026-12-31
Completion
2027-05-05

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07632469 on ClinicalTrials.gov