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

MediBeacon

Status and phase: Completed; Phase 3

Conditions: Kidney Failure; Kidney Diseases; Kidney Injury

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05777174

100-201

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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149 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: MB-102

Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)

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

Experimental group

Description:

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.

Treatment:

Drug: MB-102

Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)