CompletedPhase 3

Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring

United States149 participantsStarted 2023-03-20

Plain-language summary

The goal of this clinical trial was to compare transdermal glomerular filtration rate (tGFR) to plasma-derived indexed GFR (nGFR) using MB-102 (relmapirazin) as the fluorescent compound. Adults with kidney function ranging from estimated glomerular filtration rate (eGFR) \<120 to \>15 mL/min/1.73 m2 and spanning the entire range of human skin colors as defined by the Fitzpatrick Skin Scale (FSS) were included in the study. The main questions that the study aimed to answer were: * To establish that the MB-102 transdermal fluorescence assessed GFR using the MediBeacon Transdermal GFR System with the TGFR reusable sensor with disposable adhesive ring was comparable to the measured MB-102 plasma GFR. * To evaluate the safety and effectiveness of the MediBeacon Transdermal GFR System and the TGFR reusable sensor with disposable adhesive ring for the non-invasive transdermal fluorescence detection of MB-102 in participants On dosing day, participants had the TGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon Transdermal GFR System initiated to collect background fluorescence. When this was completed, participants then received a single dose of MB-102. Blood samples were collected and fluorescent measurements were taken over a 12- or 24-hour (or longer) period, depending upon enrollment group. For those with significant renal compromise, fluorescent measurements were continued until the sensor no longer detected MB-102 in the body. Following completion of the treatment period, participants returned to the study center approximately 1 week later for a safety follow-up visit. Researchers compared the results to see if the transdermal GFR measurements were comparable to the measured plasma GFR.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 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 childbearing 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 * Men will not donate sperm during the study and for 1 month following the last dose of study drug. * 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 Exclusion Criteria: * Participants positive for COVID-19 at the time of dosing * Recent donation or loss of blood or plasma: 100 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication * Non-steroidal anti-inflammatory (NSAID) use within 3 days of MB-102 dosing * The participant has participated in a clini…

What they're measuring

Correlation of Transdermal Derived Glomerular Filtration Rate (tGFR) to the Plasma-derived Indexed Glomerular Filtration Rate (nGFR)

Timeframe: Up to 24 hours following the study dose

Trial details

NCT IDNCT05777174

SponsorMediBeacon

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-15

Results submitted2025-02-28