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

NCT05425719 | Completed Phase 3 Results FDA Drug FDA Device

• 1 other identifier: MB-100-003
• Study Type: interventional
• Target: 249
• Locations: 2 countries
• Sites: 8

Brief 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.

Conditions

Chronic Kidney Disease

Keywords

Glomerular Filtration Rate; Transdermal fluorescence detection; Relmapirazin

Outcome Measures

Primary Outcomes (1)

• Proportion of Transdermal Derived Glomerular Filtration Rate (tGFR) Values Within 30% of the nGFR Plasma-derived Indexed Glomerular Filtration Rate (nGFR) Values

  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. The comparison of transdermal derived glomerular filtration rate (tGFR) with respect to the plasma-derived indexed glomerular filtration rate (nGFR) was calculated with a double-sided 95% confidence interval (CI). The performance goal was 0.85, and success for the study was defined as a lower limit of the 95% CI greater than 0.85.

  Up to 24 hours following the study dose

Secondary Outcomes (2)

• Number of Participants With Treatment-emergent Adverse Events Associated With MB-102 Administration

  From the time of dosing through the follow-up visit, up to 10 days

• Number of Participants With Treatment-emergent Adverse Events Associated With the MediBeacon Transdermal GFR Measurement System Device

  From the time of dosing through the follow-up visit, up to 10 days

Study Arms (2)

eGFR ≥ 70 mL/min/1.73 m^2

EXPERIMENTAL

Participants with eGFR ≥ 70 mL/min/1.73 m\^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 12 hours.

Drug: MB-102; Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)

eGFR < 70 mL/min/1.73 m^2

EXPERIMENTAL

Participants with eGFR \< 70 mL/min/1.73 m\^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 24 hours.

Drug: MB-102; Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)

Interventions

MB-102 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

Also known as: Relmapirazin

eGFR < 70 mL/min/1.73 m^2; eGFR ≥ 70 mL/min/1.73 m^2

MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) DEVICE

On treatment day, participants had a transdermal sensor placed on their upper chest, and the MediBeacon Transdermal GFR Measurement System was initiated to collect background fluorescence. After collection of background fluorescence, participants received a single dose of MB-102.

eGFR < 70 mL/min/1.73 m^2; eGFR ≥ 70 mL/min/1.73 m^2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 scarring, 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

Sponsors & Collaborators

• MediBeacon: lead

Study Sites (8)

Velocity Clinical Research

Edgewater, Florida, 32132, United States

Location

Research by Design, LLC

Chicago, Illinois, 60643, United States

Location

Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location

Carolina Phase I Research

Raleigh, North Carolina, 27612, United States

Location

Endeavor Clinical Trials, LLC

San Antonio, Texas, 78240, United States

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610093, China

Location

Peking University First Hospital

Beijing, 100034, China

Location

Affiliated Hospital of Xuzhou Medical University

Xuzhou, 2210029, China

Location

Related Publications (1)

• Chan G, Pino CJ, Johnston KA, Humes HD. Estimating Changes in Glomerular Filtration Rate With Fluorescein Isothiocyanate-Sinistrin During Renal Replacement Therapy. ASAIO J. 2023 Aug 1;69(8):810-815. doi: 10.1097/MAT.0000000000001947. Epub 2023 Apr 27.

  PMID: 37104481 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

relmapirazin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Richard B Dorshow, PhD
• Organization: MediBeacon, Inc.

rbdorshow@medibeacon.com

314-735-0967

Study Officials

• Richard B Dorshow, PhD

  MediBeacon, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: June 21, 2022
• Study Start: June 14, 2022
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3); US (5)