mGFR vs tGFR in AKI

NCT07632469 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: k9467
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

AKI; GFR

Keywords

acute kidney injury; intensive care; glomerular filtration rate

Outcome Measures

Primary Outcomes (1)

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

  12 hours

Study Arms (1)

intervention group

EXPERIMENTAL

Device: transdermal GFR

Interventions

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.

intervention group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bin Du: lead

Related Publications (7)

• Dorshow RB, Debreczeny MP, Goldstein SL. GFR Measurement Using Transdermal Detection Methodology. J Am Soc Nephrol. 2025 Feb 7;36(8):1592-1602. doi: 10.1681/ASN.0000000639.

  PMID: 39918882 RESULT

• Dorshow RB, Debreczeny MP, Goldstein SL, Shieh JJ. Clinical validation of the novel fluorescent glomerular filtration rate tracer agent relmapirazin (MB-102). Kidney Int. 2024 Oct;106(4):679-687. doi: 10.1016/j.kint.2024.06.012. Epub 2024 Jul 2.

  PMID: 38964736 RESULT

• Dixon JJ, Lane K, Dalton RN, Turner C, MacPhee IAM, Chis Ster I, Philips BJ. Continuous Infusion of Low-Dose Iohexol Measures Changing Glomerular Filtration Rate in Critically Ill Patients. Crit Care Med. 2018 Mar;46(3):e190-e197. doi: 10.1097/CCM.0000000000002870.

  PMID: 29194145 RESULT

• Erley CM, Bader BD, Berger ED, Vochazer A, Jorzik JJ, Dietz K, Risler T. Plasma clearance of iodine contrast media as a measure of glomerular filtration rate in critically ill patients. Crit Care Med. 2001 Aug;29(8):1544-50. doi: 10.1097/00003246-200108000-00008.

  PMID: 11505124 RESULT

• Molitoris BA. Measuring glomerular filtration rate in the intensive care unit: no substitutes please. Crit Care. 2013 Sep 4;17(5):181. doi: 10.1186/cc12876.

  PMID: 24004539 RESULT

• Inker LA, Titan S. Measurement and Estimation of GFR for Use in Clinical Practice: Core Curriculum 2021. Am J Kidney Dis. 2021 Nov;78(5):736-749. doi: 10.1053/j.ajkd.2021.04.016. Epub 2021 Sep 11.

  PMID: 34518032 RESULT

• Dorshow RB, Friedemann J, Ross-Jones J, Johnson JR, Vitale L, Riley IR, Debreczeny MP, Harr J, Trelford LP, Goldstein SL. Accuracy of Point-of-Care Transdermal GFR Methodology. Kidney Int Rep. 2026 Jan 22;11(4):103797. doi: 10.1016/j.ekir.2026.103797. eCollection 2026 Apr.

  PMID: 41726007 RESULT

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Bin Du

CONTACT

86+69155643; dubin98@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Consultant Physician；Professor

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 5, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share