Glomerular Filtration Rate study: Lumitrace vs Iohexol
Official title MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure
ClinicalTrials.gov ID: NCT07349797
What this study is testing
What is Iohexol?
Iohexol is an investigational contrast agent being studied to help measure kidney function in adults with heart failure. is designed to be filtered by the kidneys so researchers can track how quickly it leaves the body to estimate glomerular filtration rate.
Also referred to as Omnipaque 300.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years;
- Eligible female non-pregnant participants who are either not of child-bearing potential or willing to use adequate contraception during the trial
- Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post-dose
- For women of child-bearing potential, the participant should have a negative serum pregnancy test at screening, and agrees to one of the following...
- Men will not donate sperm during the study and for 1 month following the last dose of study drug.
You likely can't join if
- Intolerance to iohexol or iodine allergy
- Known allergy to relmapirazin or severe hypersensitivity reactions to adhesives or related products
- Administration of iohexol for cross-sectional imaging within a week from the dosing visit
- Limb amputation
- Primary kidney disease (e.g., glomerulonephritis or polycystic kidney disease)
- Acute kidney injury (AKI) or unstable kidney function at the time of dosing visit
See the full eligibility criteria
- Age ≥18 years;
- Eligible female non-pregnant participants who are either not of child-bearing potential or willing to use adequate contraception during the trial
- Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post-dose
- 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.
- Men will not donate sperm during the study and for 1 month following the last dose of study drug.
- Clinical syndrome: Symptoms and/or signs consistent with heart failure (e.g., dyspnea, fatigue, edema, rales, elevated JVP), and
- 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
- Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol
- Adequate venous access sufficient to allow blood sampling per protocol requirements
- Intolerance to iohexol or iodine allergy
- Known allergy to relmapirazin or severe hypersensitivity reactions to adhesives or related products
- Administration of iohexol for cross-sectional imaging within a week from the dosing visit
- Limb amputation
- Primary kidney disease (e.g., glomerulonephritis or polycystic kidney disease)
- Acute kidney injury (AKI) or unstable kidney function at the time of dosing visit
- Clinical signs of excessive volume overload (edema grade 3-4 or ascites)
- Significant scarring, tattoos, or alterations in pigmentation on the sternum or other sensor location areas that would alter sensor readings
- Use of tanning sprays, tanning products, etc. on the upper chest within 2 weeks of dosing day
- 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
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.