mGFR vs tGFR in AKI (NCT07632469) | Clinical Trial Compass
Not Yet RecruitingPhase 4
mGFR vs tGFR in AKI
50 participantsStarted 2026-06-08
Plain-language 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
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing two methods of measuring kidney function — mGFR and tGFR — in people with AKI. Can you help me understand what the difference is between these two measurement approaches, and why it matters which one is used to track my kidney function?
2Since this study is in Phase 4 and focused on validating a measurement tool rather than testing a new treatment, does participating actually change anything about the care or treatment I'd receive, or would it mostly involve extra kidney function tests over a 12-hour period?
3The trial isn't recruiting yet — given that, do you think it's worth waiting to see if I might be eligible when it opens, or would that delay conflict with decisions that need to be made about my AKI care right now?
4If the goal is to see how well tGFR matches the gold-standard mGFR measurement, what would either of these tests actually involve for me practically — for example, how many blood draws or urine collections would I need to do in that 12-hour window?
5Are there standard-of-care approaches for monitoring kidney function in AKI that you'd recommend regardless of whether this trial opens up, and how would participating in this study fit alongside those?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To validate the agreement of TGFR with mGFR in AKI patients at both the segmented and overall 0-12 hour levels.