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

A Pivotal, Open Label, Multi-Center, Safety and Pharmacokinetic Study of MB-102 (Relmapirazin) and the Use of the MediBeacon Transdermal GFR Measurement System in Normal and Renal Compromised Subjects for the Evaluation of Kidney Function

This is a multi-center, open-label, pivotal study comparing transdermal glomerular filtration rate (tGFR) to plasma-derived indexed GFR (nGFR) with MB-102 (relmapirazin) as the fluorophore. Participants will span the GFR range of values from normal to stage 4 chronic kidney disease (CKD) and span the entire range of human skin colors as defined by the Fitzpatrick Skin Scale (FSS). The safety and pharmacokinetics of MB-102 and the safety of the MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) will also be evaluated.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: MB-102; Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)

Detailed Description

Approximately 50% of participants will have GFR > 70 mL/min/1.73m^2, and approximately 50% of participants will have GFR < 70 mL/min/1.73m^2.

Approximately 50% of participants enrolled in the United States will have a FSS value of I-III, and 50% of participants will be FSS IV-VI. The FSS stratification will not apply to participants enrolled in China because the population demographic is unlikely to support the full FSS spectrum.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Richard B Dorshow, PhD; Phone Number: 314-735-0967; Email: rbdorshow@medibeacon.com

Study Locations

• China
  • Beijing, China, 100034
    • Peking University First Hospital
  • Xuzhou, China, 2210029
    • Affiliated Hospital of Xuzhou Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610093
      • West China Hospital of Sichuan University
• United States
  • Florida
    • Edgewater, Florida, United States, 32132
      • Velocity Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60643
      • Research by Design, LLC
  • Minnesota
    • Saint Paul, Minnesota, United States, 55114
      • Nucleus Network
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Carolina Phase I Research
  • Texas
    • San Antonio, Texas, United States, 78240
      • Endeavor Clinical Trials, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 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
• 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 via PCR testing for COVID-19 (Vaccinated participants without symptoms of COVID-19 are not required to undergo PCR testing but may be tested at the discretion of the study site)
• 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
• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eGFR ≥ 70 mL/min/1.73 m^2; Participants with eGFR ≥ 70 mL/min/1.73 m^2 will receive one 130 mg dose of MB-102 and a transdermal sensor placed on their chest. Blood samples and fluorescent measurements will be collected over 12 hours.	Drug: 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; Other Names: Relmapirazin; Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR); On treatment day, participants will have a transdermal sensor placed on their chest in the area between the shoulders (including the pectoralis and sternum area), and the MediBeacon Transdermal GFR Measurement System will be initiated to collect background fluorescence. After collection of background fluorescence, participants will then receive a single dose of MB-102.
Experimental: eGFR < 70 mL/min/1.73 m^2; Participants with eGFR < 70 mL/min/1.73 m^2 will receive one 130 mg dose of MB-102 and a transdermal sensor placed on their chest. Blood samples and fluorescent measurements will be collected over 24 hours.	Drug: 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; Other Names: Relmapirazin; Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR); On treatment day, participants will have a transdermal sensor placed on their chest in the area between the shoulders (including the pectoralis and sternum area), and the MediBeacon Transdermal GFR Measurement System will be initiated to collect background fluorescence. After collection of background fluorescence, participants will then receive a single dose of MB-102.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of transdermal derived glomerular filtration rate (tGFR) to the plasma-derived indexed glomerular filtration rate (nGFR)	Statistical agreement between tGFR and nGFR will be calculated.	Up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-emergent adverse events associated with MB-102 administration	An adverse event is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, temporally associated with the use of a medicinal product, whether or not related to the investigational medical device or drug.	Up to 10 days
Number of participants with treatment-emergent adverse events associated with the MediBeacon Transdermal GFR Measurement System device	An adverse event is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, temporally associated with the use of a medicinal product, whether or not related to the investigational medical device or drug.	Up to 10 days

Collaborators and Investigators

• Sponsor: MediBeacon
• Investigators: Study Director: Richard B Dorshow, PhD, MediBeacon, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2022
• Primary Completion (Actual): February 15, 2023
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Glomerular Filtration Rate; Transdermal fluorescence detection; Relmapirazin
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: MB-100-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes