Iohexol / Heart Failure / Glomerular Filtration Rate · Interventional Study

MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure

ClinicalTrials.gov · August 14, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for a planned feasibility study, not a report of results. It describes a small single-arm trial designed to evaluate the accuracy of a transdermal GFR measurement device (MediBeacon tGFR system) compared to plasma-derived GFR in adults with heart failure. No outcomes or effect estimates are reported; the record documents study design and planned enrollment only.

What was studied

Interventional, Single Group, Open label, Other purpose. Glomerular Filtration Rate, Heart Failure; age from 18 Years. Intervention: 130 mg Lumitrace/1.5 mL Iohexol. Compared with: Plasma-derived indexed glomerular filtration rate (nGFRBSA) measurement. n = 15. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a small, single-centre feasibility study of a novel non-invasive device for GFR measurement in a specific population; no results are reported in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Correlation of Transdermal Derived Glomerular Filtration Rate (tGFR) to the Plasma-derived Indexed Glomerular Filtration Rate (nGFR) (assessed at Day 1)

DesignInterventional, Single Group, Open label, Other purpose

PopulationGlomerular Filtration Rate, Heart Failure; age from 18 Years

Sample size15

Intervention130 mg Lumitrace/1.5 mL Iohexol

ComparatorPlasma-derived indexed glomerular filtration rate (nGFRBSA) measurement

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment15

Primary outcome measureCorrelation of Transdermal Derived GFR (tGFR) to Plasma-derived Indexed GFR (nGFR), Day 1

Follow-up duration on study day10-24 hours

Post-study follow-up contactApproximately 7 days after last exposure

Caveats

This is a registry record only; no results, effect sizes, or outcome data are reported.
Small planned sample size (n=15) limits statistical power and generalizability.
Single-arm design with no control group; accuracy inferred by correlation to reference standard only.
Study is still recruiting; completion and outcome data not yet available in this record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Single-arm interventional device study with no comparator arm design.

Directness

moderate

Directly addresses accuracy of transdermal GFR measurement against plasma reference standard.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Registry record lacks detail on blinding, data handling, and analysis plan.

Sample adequacy

limited

Planned enrollment of only 15 participants; underpowered for robust clinical validation.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07349797). This is a study registration, not published results. Lead sponsor: MediBeacon. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 15 participants (ESTIMATED). Conditions: Glomerular Filtration Rate, Heart Failure. Interventions: DEVICE: Lumitrace; DEVICE: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (tGFR); DRUG: Iohexol. Primary outcome measures: Correlation of Transdermal Derived Glomerular Filtration Rate (tGFR) to the Plasma-derived Indexed Glomerular Filtration Rate (nGFR) , Day 1. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

IohexolNCT07349797Heart FailureMediBeaconGlomerular Filtration RateLumitraceMediBeacon Transdermal Glomerular Filtration Rate Measurement System (tGFR)