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NCT07349797 · ClinicalTrials.gov registry record · NA
MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure
A NA study, sponsored by MediBeacon.
- Not yet
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT07349797: Clinical Trial NA study, sponsored by MediBeacon.
NCT07349797 is a NA study that has not yet begun recruiting, run by MediBeacon. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07349797, a NA study, has not yet begun recruiting, sponsored by MediBeacon.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to evaluate the accuracy and feasibility of transdermal glomerular filtration rate (tGFR) assessment using relmapirazin (Lumitrace) and the MediBeacon tGFR system compared to plasma clearance measurement of GFR in adults with heart failure. The main question it aims to answer is the comparison of the transdermal-derived GFR for each participant using the MediBeacon tGFR to their nGFRBSA measurement. Participants will participate in a Screening visit that will take place within 15 days of the scheduled administration of Lumitrace and iohexol. On dosing day, participants will have the tGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon Transdermal GFR System initiated to collect background fluorescence. Following an injection of Lumitrace and iohexol and the initiation of GFR assessments, participants will be followed at the study center for 10-24 hours. All participants will participate in a follow-up phone call approximately 7 days after the last exposure to Lumitrace and iohexol. Researchers will analyze the results to compare the tGFR values to the nGFRBSA measurements for each participant.
Primary Outcome
The performance measure of P30 is defined as the proportion of transdermal derived GFR values that are within 30% of the measured plasma-derived GFR across all participants. The comparison of transdermal derived glomerular filtration rate (tGFR) with respect to the plasma-derived indexed glomerular filtration rate (nGFR) will be calculated with a double-sided 95% confidence interval (CI). The performance goal is 0.75, and success for the study is defined as a lower limit of the 95% CI greater th
Interventions
- DRUG Iohexol
- DEVICE Lumitrace
- DEVICE MediBeacon Transdermal Glomerular Filtration Rate Measurement System (tGFR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2026-04 |
| Est. Completion | 2027-01 |
| Phase | NA |
What is known before NCT07349797 opens enrollment
NCT07349797 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Iohexol is the first listed.
NCT07349797 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07349797 about?
NCT07349797 is a clinical study titled "MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure". The goal of this clinical trial is to evaluate the accuracy and feasibility of transdermal glomerular filtration rate (tGFR) assessment using relmapirazin (Lumitrace) and the MediBeacon tGFR system compared to plasma clearance measurement of GFR in adults with heart failure. The main question it ai...
What is the current status of trial NCT07349797?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2026-04. Estimated completion is 2027-01.
What interventions are being tested in trial NCT07349797?
The interventions under investigation include: Iohexol (DRUG), Lumitrace (DEVICE), MediBeacon Transdermal Glomerular Filtration Rate Measurement System (tGFR) (DEVICE).
Who is sponsoring clinical trial NCT07349797?
This trial is sponsored by MediBeacon, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07349797's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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