MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure (NCT07349797)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Columbia University — New York, New York
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Columbia University — New York, New York
📞 Contact the Study Coordinator
Phone: (314) 735-0968
Email: rbdorshow@medibeacon.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.