MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMediBeacon
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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. 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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Lumitrace
Device18.6 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
MediBeacon Transdermal Glomerular Filtration Rate Measurement System (tGFR)
DeviceSite 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.
Iohexol
Drug1.5 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
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: 130 mg Lumitrace/1.5 mL IohexolExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Correlation of Transdermal Derived Glomerular Filtration Rate (tGFR) to the Plasma-derived Indexed Glomerular Filtration Rate (nGFR)
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.
Time frame
Day 1 Source ClinicalTrials.gov