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

Sponsor

MediBeacon (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05777174

Collaborator

(none)

220

Enrollment

Locations

Arms

Anticipated Duration (Months)

110

Patients Per Site

12.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to establish that the MB-102 transdermal fluorescence-measured Glomerular Filtration Rate (GFR) using the MediBeacon® Measurement System with the Transdermal Glomerular Filtration Rate (TGFR) reusable sensor with disposable adhesive ring is comparable to the plasma-measured MB-102 GFR in normal and compromised renal function participants with different skin color types.

Condition or Disease	Intervention/Treatment	Phase
Kidney Diseases Kidney Injury Kidney Failure	Drug: MB-102 Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

An Open Label, Multi-Center, Safety and Pharmacokinetic Bridging Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring in Normal and Renal Compromised Subjects for the Evaluation of Kidney Function

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants with eGFR ≥ 70 mL/min/1.73 m^2 MB-102 (130 mg) will be administered to participants with estimated glomerular filtration rate (eGFR) eGFR ≥ 70 mL/min/1.73 m^2, and fluorescence measured using the MediBeacon Transdermal GFR Measurement System. Approximately half of the participants are to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.	Drug: MB-102 130 mg 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 the TGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon® Transdermal GFR Measurement System will be initiated to collect background fluorescence. When this is completed, participants will then receive a single dose of MB-102. Fluorescent measurements will be collected for 12-24 hours. For those with significant renal compromise, fluorescent measurements will continue until the sensor no longer detects MB-102 in the body.
Experimental: Participants with eGFR < 70 mL/min/1.73 m^2 MB-102 (130 mg) will be administered to participants with estimated glomerular filtration rate (eGFR) eGFR < 70 mL/min/1.73 m^2, and fluorescence measured using the MediBeacon Transdermal GFR Measurement System. Approximately half of the participants are to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.	Drug: MB-102 130 mg 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 the TGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon® Transdermal GFR Measurement System will be initiated to collect background fluorescence. When this is completed, participants will then receive a single dose of MB-102. Fluorescent measurements will be collected for 12-24 hours. For those with significant renal compromise, fluorescent measurements will continue until the sensor no longer detects MB-102 in the body.

Arm

Intervention/Treatment

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

MB-102 (130 mg) will be administered to participants with estimated glomerular filtration rate (eGFR) eGFR ≥ 70 mL/min/1.73 m^2, and fluorescence measured using the MediBeacon Transdermal GFR Measurement System. Approximately half of the participants are to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.

Drug: MB-102

130 mg 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 the TGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon® Transdermal GFR Measurement System will be initiated to collect background fluorescence. When this is completed, participants will then receive a single dose of MB-102. Fluorescent measurements will be collected for 12-24 hours. For those with significant renal compromise, fluorescent measurements will continue until the sensor no longer detects MB-102 in the body.

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

MB-102 (130 mg) will be administered to participants with estimated glomerular filtration rate (eGFR) eGFR < 70 mL/min/1.73 m^2, and fluorescence measured using the MediBeacon Transdermal GFR Measurement System. Approximately half of the participants are to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.

Drug: MB-102

130 mg 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)

Outcome Measures

Primary Outcome Measures

Correlation of transdermal derived glomerular filtration rate (tGFR) to the plasma-derived indexed glomerular filtration rate (nGFR) [Up to 24 hours]
Statistical agreement between tGFR and nGFR will be calculated.

Secondary Outcome Measures

Number of participants with treatment-emergent adverse events associated with MB-102 administration [Up to 10 days]
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.
Number of participants with treatment-emergent adverse events associated with the MediBeacon Transdermal GFR Measurement System device [Up to 10 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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