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

NCT ID: NCT05777174

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2024-04-15

Brief 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.

Conditions

Kidney Diseases; Kidney Injury; Kidney Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Participants with eGFR ≥ 70 mL/min/1.73 m^2

A TGFR Reusable Sensor with Disposable Adhesive Ring was placed on participants' chests at least 15 minutes prior to dosing on treatment day, and the MediBeacon Transdermal GFR System was initiated to collect background fluorescence. After the collection of background fluorescence, a single dose of MB-102 (130 mg) was administered intravenously to participants with estimated glomerular filtration rate (eGFR) eGFR ≥ 70 mL/min/1.73 m\^2. Approximately half of the participants had Fitzpatrick Scale Type I, II or III, and half had Type IV, V and VI skin color type. Blood samples and fluorescent measurements were collected over 12 hours.

Group Type: EXPERIMENTAL

MB-102

Intervention Type: DRUG

18.6 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)

Intervention Type: DEVICE

On treatment day, participants had the TGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon® Transdermal GFR Measurement System was initiated to collect background fluorescence. When this was completed, participants received a single dose of MB-102. Fluorescent measurements were collected for 12-24 hours. For those with significant renal compromise, fluorescent measurements were continued until the sensor no longer detected MB-102 in the body.

Participants with eGFR < 70 mL/min/1.73 m^2

A TGFR Reusable Sensor with Disposable Adhesive Ring was placed on participants' chests at least 15 minutes prior to dosing on treatment day, and the MediBeacon Transdermal GFR System was initiated to collect background fluorescence. After the collection of background fluorescence, a single dose of MB-102 (130 mg) was administered intravenously to participants with estimated glomerular filtration rate eGFR \< 70 mL/min/1.73 m\^2. Approximately half of the participants had Fitzpatrick Scale Type I, II or III, and half had Type IV, V and VI skin color type. Blood samples and fluorescent measurements were collected over 24 hours.

Group Type: EXPERIMENTAL

MB-102

Intervention Type: DRUG

18.6 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)

Intervention Type: DEVICE

On treatment day, participants had the TGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon® Transdermal GFR Measurement System was initiated to collect background fluorescence. When this was completed, participants received a single dose of MB-102. Fluorescent measurements were collected for 12-24 hours. For those with significant renal compromise, fluorescent measurements were continued until the sensor no longer detected MB-102 in the body.

Interventions

MB-102

18.6 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

Intervention Type: DRUG

MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)

On treatment day, participants had the TGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon® Transdermal GFR Measurement System was initiated to collect background fluorescence. When this was completed, participants received a single dose of MB-102. Fluorescent measurements were collected for 12-24 hours. For those with significant renal compromise, fluorescent measurements were continued until the sensor no longer detected MB-102 in the body.

Intervention Type: DEVICE

Other Intervention Names

Relmapirazin

Eligibility Criteria

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 clinical trial and has received an investigational product within the following time ranges: prior to the first dosing day in the current study: either 30 days or 5 half-lives of the investigational product (whichever duration is longer).
• History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
• History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, MB-102 or other related products (intolerance to a drug is not considered a drug allergy).
• Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial
• Significant scaring, tattoos or alterations in pigmentation on the sternum or other sensor location testing areas that would alter sensor readings versus other areas of the skin
• Use of tanning sprays, tanning products etc. on the upper chest within 2 weeks of dosing day
• Use make-up, lotions, Vaseline or other products on the area of the upper chest on the day prior to or the day of dosing
• Any serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, or psychiatric condition that in the opinion of the investigator would limit the participant's ability to complete study requirements or may put the participant 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MediBeacon

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research by Design, LLC

Chicago, Illinois, United States

Centricity Research

Columbus, Ohio, United States

PPD

Austin, Texas, United States

Clinical Advancement Center, PLLC

San Antonio, Texas, United States

Endeavor Clinical Trials, LLC

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

100-201

Identifier Type: -

Identifier Source: org_study_id