RecruitingNot applicable

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections, Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well the MediBeacon system and an injected drug called Lumitrace measure kidney function through the skin. It compares these results with blood-based tests 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 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old.
  • Have heart failure with symptoms, confirmed by the study doctor. Tests must also show heart problems, high pressure inside the heart, or raised levels of heart failure markers in the blood.
  • Be able to give your own consent and follow study rules.
  • Have veins that allow the needed blood draws.
  • Women must not be pregnant. Those who can become pregnant must have a negative blood pregnancy test and use an accepted birth control method or avoid sex during the study.
  • Men must use accepted birth control or avoid sex from dosing day until at least 7 days after the dose.
  • Men must not donate sperm during the study or for 1 month after the last study drug dose.

Who can't join

  • Cannot tolerate iohexol, are allergic to iodine or relmapirazin (Lumitrace), or have severe allergic reactions to adhesives or related products.
  • Received iohexol for an imaging scan within 1 week of the dosing visit.
  • Have had an arm or leg removed.
  • Have a disease that starts in the kidneys, such as kidney inflammation or kidney cysts, or have sudden kidney injury or unstable kidney function at dosing.
  • Have severe fluid buildup, such as severe swelling or fluid in the belly.
  • Have scars, tattoos, or skin color changes where the sensor goes that could affect its readings.
  • Used tanning products on the upper chest within 2 weeks of dosing, or used makeup, lotion, Vaseline, or other products there the day before or on dosing day.
  • Within 2 weeks of joining, received a substance that can harm the kidneys or had signs of a condition that could cause sudden kidney injury.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

NY