mGFR vs tGFR in AKI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transdermal GFR.
- Who it may be relevant to
- Registry conditions: AKI, GFR. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of Agreement Between mGFR and tGFR in ICU Patients With Acute Kidney Injury
Overview
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
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, followe
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07632469 · k9467