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

March 31, 2026 updated by: MediBeacon

An Open Label, Single-Center, Safety and Pharmacokinetic Study of Lumitrace® Injection (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR System Using the TGFR Reusable Sensor With TGFR Disposable Ring for the Evaluation of Kidney Function in Patients 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 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University
        • Contact:
          • Melana Yuzefpolskaya, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years;

    1. Eligible female non-pregnant participants who are either not of child-bearing potential or willing to use adequate contraception during the trial
    2. Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post-dose
    3. For women of child-bearing potential, the participant should have a negative serum pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly i.e. abstinence, oral contraceptive either combined or progesterone alone; injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, IUD device or system or male partner sterilization
    4. Men will not donate sperm during the study and for 1 month following the last dose of study drug.

  2. Diagnosis of symptomatic heart failure: Subject has symptomatic heart failure, ACC/AHA Stage C or D, ambulatory or hospitalized for heart failure, adjudicated by a principal investigator, and meeting both of the following:

    1. Clinical syndrome: Symptoms and/or signs consistent with heart failure (e.g., dyspnea, fatigue, edema, rales, elevated JVP), and

    2. Objective evidence of heart failure (≥1 of):

      • Left ventricular systolic dysfunction or other structural abnormalities (left atrial enlargement, left ventricular hypertrophy, diastolic dysfunction on echocardiography) or
      • Hemodynamic evidence of elevated filling pressures by invasive or noninvasive assessment, or
      • Elevated natriuretic peptides obtained within 90 days from enrollment: NT-proBNP ≥300 pg/mL (BNP ≥100 pg/mL) in sinus rhythm or NT-proBNP ≥900 pg/mL (BNP ≥300 pg/mL) in atrial fibrillation
  3. Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol
  4. Adequate venous access sufficient to allow blood sampling per protocol requirements

Exclusion Criteria:

To be eligible for the study, participants must not meet any of the criteria noted below:

  1. Intolerance to iohexol or iodine allergy
  2. Known allergy to relmapirazin or severe hypersensitivity reactions to adhesives or related products
  3. Administration of iohexol for cross-sectional imaging within a week from the dosing visit
  4. Limb amputation
  5. Primary kidney disease (e.g., glomerulonephritis or polycystic kidney disease)
  6. Acute kidney injury (AKI) or unstable kidney function at the time of dosing visit
  7. Clinical signs of excessive volume overload (edema grade 3-4 or ascites)
  8. Significant scarring, tattoos, or alterations in pigmentation on the sternum or other sensor location areas that would alter sensor readings
  9. Use of tanning sprays, tanning products, etc. on the upper chest within 2 weeks of dosing day
  10. Use of make-up, lotions, Vaseline or other products on the area of the upper chest on the day prior to or the day of dosing
  11. Participants who have received nephrotoxic agent or signs or symptoms suggestive of a condition that may result in acute kidney injury within two weeks of study entry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 130 mg Lumitrace/1.5 mL Iohexol
Participants will have the tGFR sensor placed and background measurements initiated. Participants will then receive a single intravenous 130 mg dose of Lumitrace followed by 1.5 mL of iohexol. They will be followed at the study center for 10-24 hours.
Device: Lumitrace
18.6 mg/mL in a 7.0 mL volume administered by intravenous injection over 30 - 60 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 - 60 seconds
Other Names:
  • Relmapirazin
Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (tGFR)
Site staff will place and affix the tGFR reusable sensor and Disposable Ring for all enrolled participants. One sensor will be attached to the upper chest. An adhesive clip, surgical tape or other means may also be used to alleviate tension on the sensor cord. TGFR assessments will be collected for a minimum of 6 hours up to 8 hours post Lumitrace injection.
Drug: Iohexol
1.5 mL of a 647 mg/mL solution administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 -60 seconds
Other Names:
  • Omnipaque 300

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of Transdermal Derived Glomerular Filtration Rate (tGFR) to the Plasma-derived Indexed Glomerular Filtration Rate (nGFR)
Time Frame: Day 1
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 than 0.75.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MediBeacon

Investigators

  • Study Director: Richard B Dorshow, PhD, MediBeacon, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100-300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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