Pharmacokinetics and Safety of MB-102 (Relmapirazin) and the MediBeacon Transdermal GFR Measurement System in Evaluation of Kidney Function in Normal and Renal Compromised Subjects

Last updated: March 22, 2024
Sponsor: MediBeacon
Overall Status: Completed

Phase

3

Condition

Renal Failure

Nephropathy

Kidney Disease

Treatment

MB-102

MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)

Clinical Study ID

NCT05425719
MB-100-003
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this clinical trial was to compare transdermal glomerular filtration rate (tGFR) to plasma-derived indexed (to body surface area; BSA) GFR (nGFR) using MB-102 (relmapirazin) as the fluorescent compound. Adults with kidney function ranging from normal to Stage 4 chronic kidney disease (CKD) and participants 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 measured GFR using the MediBeacon Transdermal GFR Measurement System is comparable to the measured MB-102 plasma GFR

  • To evaluate the safety and tolerability of a single dose of MB-102 in study participants

  • To evaluate the safety and effectiveness of the MediBeacon Transdermal GFR Measurement System (TGFR) for the non-invasive transdermal fluorescence detection of MB-102 in participants

Participants had a transdermal sensor placed on their upper chest, and the TGFR collected background fluorescence. Participants then received a single dose of MB-102. Blood samples were collected and fluorescent measurements were taken over a 12- to 24-hour period. 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 in those with and without normal kidney function and different skin coloration.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eligible female non-pregnant participants who are either not of child-bearingpotential or willing to use adequate contraception during the trial
  • Males must be willing to practice abstinence or utilize adequate contraception fromdosing day to at least 7 days post-dose
  • For women of child-bearing potential, the participant should have a negative serumpregnancy test at screening, and agrees to one of the following acceptablecontraceptive methods used consistently and correctly i.e. abstinence, oralcontraceptive either combined or progesterone alone; injectable progesterone, implantsof levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, IUDdevice or system or male partner sterilization
  • Men will not donate sperm during the study and for 1 month following the last dose ofstudy drug
  • Participants who are capable of directly providing informed consent and who can complywith the requirements and restrictions required by the protocol
  • Adequate venous access sufficient to allow blood sampling per protocol requirements

Exclusion

Exclusion Criteria:

  • Participants positive via PCR testing for COVID-19 (Vaccinated participants withoutsymptoms of COVID-19 are not required to undergo PCR testing but may be tested at thediscretion of the study site)
  • Recent donation or loss of blood or plasma: 100 mL to 499 mL within 30 days prior tothe initial dose of the study medication; or more than 499 mL within 56 days prior tothe initial dose of study medication
  • Non-steroidal anti-inflammatory (NSAID) use within 3 days of MB-102 dosing
  • Participant has participated in a clinical trial and has received an investigationalproduct within the following time ranges: prior to the first dosing day in the currentstudy: either 30 days or 5 half-lives of the investigational product (whicheverduration is longer)
  • History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
  • History of severe allergic hypersensitivity reactions (unacceptable adverse events) oranaphylactoid reaction to any allergen including drugs, MB-102 or other relatedproducts (intolerance to a drug is not considered a drug allergy).
  • Any characteristics which, in the opinion of the investigator, makes the participant apoor candidate for participation in the clinical trial
  • Significant scarring, tattoos or alterations in pigmentation on the sternum or othersensor location testing areas that would alter sensor readings versus other areas ofthe skin
  • Any serious or uncontrolled medical disorder, active infection, physical exam finding,laboratory finding, or psychiatric condition that in the opinion of the investigatorwould limit the participant's ability to complete study requirements or may put theparticipant at increased risk or compromise the interpretability of study results.
  • Currently receiving dialysis
  • Currently anuric
  • Positive serum pregnancy test
  • Participants with an eGFR > 120 mL/min/1.73m^2

Study Design

Total Participants: 249
Treatment Group(s): 2
Primary Treatment: MB-102
Phase: 3
Study Start date:
June 14, 2022
Estimated Completion Date:
February 15, 2023

Connect with a study center

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610093
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, 100034
    China

    Site Not Available

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, 200040
    China

    Site Not Available

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, 2210029
    China

    Site Not Available

  • Velocity Clinical Research

    Edgewater, Florida 32132
    United States

    Site Not Available

  • Research by Design, LLC

    Chicago, Illinois 60643
    United States

    Site Not Available

  • Nucleus Network

    Saint Paul, Minnesota 55114
    United States

    Site Not Available

  • Carolina Phase I Research

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Endeavor Clinical Trials, LLC

    San Antonio, Texas 78240
    United States

    Site Not Available

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