Pharmacokinetics of MB-102 and Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types

NCT02772276 | Completed Phase 2 Results FDA Drug FDA Device

• 1 other identifier: ORFM-2
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 3

Brief Summary

This study was a pilot, safety, and pharmacokinetic study of MB-102 versus iohexol and the use of the non-invasive optical renal function monitor (ORFM) device in normal and compromised renal function participants with different skin color types.

Conditions

Acute Kidney Injury

Keywords

Glomerular Filtration Rate

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events

  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.

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

Secondary Outcomes (23)

• Maximum Plasma Concentration (Cmax) of MB-102

  Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

• Maximum Plasma Concentration (Cmax) of Iohexol

  Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

• Time to Maximum Plasma Concentration (Tmax) of MB-102

  Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

• Time to Maximum Plasma Concentration (Tmax) of Iohexol

  Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

• The Elimination Half-life of MB-102

  Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

Study Arms (13)

Normal-CKD Stage 2/QuantumLeap

EXPERIMENTAL

MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Drug: MB-102-- single dose of 4 µmol/kg; Drug: Iohexol; Device: QuantumLeap

CKD Stage 3-4/QuantumLeap

EXPERIMENTAL

MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

Drug: MB-102-- single dose of 4 µmol/kg; Drug: Iohexol; Device: QuantumLeap

Normal-CKD Stage 2/Radiance

EXPERIMENTAL

MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Radiance ORFM device. Approximately half of the participants were 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-- single dose of 4 µmol/kg; Drug: Iohexol; Device: Radiance

CKD Stage 3-5/Radiance

EXPERIMENTAL

MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Radiance ORFM device. Approximately half of the participants were 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-- single dose of 4 µmol/kg; Drug: Iohexol; Device: Radiance

Normal-CKD Stage 2/Brilliance algorithm optimization

EXPERIMENTAL

MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Algorithm optimization of the Brilliance sensor was conducted. Approximately half of the participants were 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-- single dose of 4 µmol/kg; Device: Brilliance (1 or 2 sensors)

CKD Stage 3-5/Brilliance algorithm optimization

EXPERIMENTAL

MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. Algorithm optimization of the Brilliance sensor was conducted. Approximately half of the participants were 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-- single dose of 4 µmol/kg; Device: Brilliance (1 or 2 sensors)

Normal-CKD Stage 2/Brilliance sensor optimization

EXPERIMENTAL

MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Sensor optimization of the Brilliance device was conducted. Approximately half of the participants were 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-- single dose of 4 µmol/kg; Device: Brilliance (1 or 2 sensors)

Normal-CKD Stage 2/Brilliance sensor validation

EXPERIMENTAL

MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Validation of the Brilliance sensor was conducted. Approximately half of the participants were 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-- single dose of 4 µmol/kg; Device: Brilliance (1 or 2 sensors)

CKD Stage 3-5/Brilliance sensor validation

EXPERIMENTAL

MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. Validation of the Brilliance sensor was conducted. Approximately half of the participants were 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-- single dose of 130 mg; Device: Brilliance (1 or 2 sensors)

Normal-CKD Stage 2/Brilliance (1-2 sensors)

EXPERIMENTAL

MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. A subset of participants in this arm received two doses of MB-102, 12 hours apart.

Drug: MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart; Device: Brilliance (1 or 2 sensors)

Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor)

EXPERIMENTAL

MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors and 2-part sensor). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. A subset of participants in this arm received two doses of MB-102, 12 hours apart.

Drug: MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart; Device: Brilliance (1 or 2 sensors); Device: Brilliance (2-part sensor)

Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor) and 2 doses MB-102

EXPERIMENTAL

Two doses of MB-102 administered to participants 12 hours apart, with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors and 2-part sensor). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were 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-- two doses of 130 mg 24 hours apart; Device: Brilliance (1 or 2 sensors); Device: Brilliance (2-part sensor)

CKD Stage 3-5/Brilliance 1-2 sensors

EXPERIMENTAL

MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were 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-- single dose of 130 mg; Device: Brilliance (1 or 2 sensors)

Interventions

MB-102-- single dose of 4 µmol/kg DRUG

4 µmol/kg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds.

Also known as: Relmapirazin

CKD Stage 3-4/QuantumLeap; CKD Stage 3-5/Brilliance algorithm optimization; CKD Stage 3-5/Radiance; Normal-CKD Stage 2/Brilliance algorithm optimization; Normal-CKD Stage 2/Brilliance sensor optimization; Normal-CKD Stage 2/Brilliance sensor validation; Normal-CKD Stage 2/QuantumLeap; Normal-CKD Stage 2/Radiance

MB-102-- single dose of 130 mg DRUG

130 mg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds. A subset of participants will receive two doses of MB-102, 12 hours apart.

Also known as: Relmapirazin

CKD Stage 3-5/Brilliance 1-2 sensors; CKD Stage 3-5/Brilliance sensor validation

MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart DRUG

130 mg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds.

Also known as: Relmapirazin

Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor); Normal-CKD Stage 2/Brilliance (1-2 sensors)

MB-102-- two doses of 130 mg 24 hours apart DRUG

4 µmol/kg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds. A subset of participants will receive two doses of MB-102, 12 hours apart.

Also known as: Relmapirazin

Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor) and 2 doses MB-102

Iohexol DRUG

5 mL of a 647 mg/mL solution administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds

Also known as: Omnipaque 300

CKD Stage 3-4/QuantumLeap; CKD Stage 3-5/Radiance; Normal-CKD Stage 2/QuantumLeap; Normal-CKD Stage 2/Radiance

QuantumLeap DEVICE

Optical Renal Function Monitor (ORFM)

CKD Stage 3-4/QuantumLeap; Normal-CKD Stage 2/QuantumLeap

Radiance DEVICE

Optical Renal Function Monitor (ORFM)

CKD Stage 3-5/Radiance; Normal-CKD Stage 2/Radiance

Brilliance (1 or 2 sensors) DEVICE

Optical Renal Function Monitor (ORFM)

CKD Stage 3-5/Brilliance 1-2 sensors; CKD Stage 3-5/Brilliance algorithm optimization; CKD Stage 3-5/Brilliance sensor validation; Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor); Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor) and 2 doses MB-102; Normal-CKD Stage 2/Brilliance (1-2 sensors); Normal-CKD Stage 2/Brilliance algorithm optimization; Normal-CKD Stage 2/Brilliance sensor optimization; Normal-CKD Stage 2/Brilliance sensor validation

Brilliance (2-part sensor) DEVICE

Optical Renal Function Monitor (ORFM)

Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor); Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor) and 2 doses MB-102

Eligibility Criteria

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

You may qualify if:

• Age \> 22 years - male or female
• Eligible female non-pregnant participants who are either not of childbearing 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
• Participants willing to comply with study requirements
• Participants who have signed an informed consent form
• Normal or non-clinically significant screening and baseline 12-lead electrocardiogram (ECG) in the opinion of the principal investigator (PI)
• Adequate venous access sufficient to allow blood sampling per protocol requirements
• Age \> 18 years - male or female
• Eligible female non-pregnant participants who are either not of childbearing 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
• Participants willing to comply with study requirements
• Participants who have signed an informed consent form
• Normal or non-clinically significant screening and baseline 12-lead ECG in the opinion of the PI
• Adequate venous access sufficient to allow blood sampling per protocol requirements
• Normal-CKD Stage 2/QuantumLeap; Normal-CKD Stage 2/Radiance; Normal-CKD Stage 2/Brilliance algorithm optimization; Normal-CKD Stage 2/Brilliance sensor optimization; Normal-CKD Stage 2/Brilliance sensor optimization; and Normal-CKD Stage 2/Brilliance (1-2 sensors)

You may not qualify if:

• Women who are pregnant, lactating or planning to become pregnant during the study, or women who are of childbearing potential unwilling to use a barrier method of birth control
• Intolerant to venipuncture
• 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
• Participation in another interventional trial within 30 days of screening or concurrently enrolled in any other medical research study which could impact the results of the study
• History of drug or alcohol abuse within the past year
• History of allergy or hypersensitivity to MB-102 or iohexol, or other related (iodinated contrast media) products, or any of the inactive ingredients
• History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
• Any food allergy, intolerance, restriction or special diet that, in the opinion of the PI, could contraindicate the subject's participation in this study
• Participants who have allergies to 2 or more classes of drugs. (Intolerance to a drug is not considered a drug allergy)
• Stable use (no changes within 30 days) of prescription or over the counter (OTC) medications
• Non-steroidal anti-inflammatory drug (NSAID) use within 2 days of dosing day
• History of coagulation disorders or bleeding disorders that in the judgement of the investigator places the subject at undue risks for study related procedures
• Are homozygous for sickle cell disease
• Have a known thyroid disorder
• Have pheochromocytoma

Sponsors & Collaborators

• MediBeacon: lead

Study Sites (3)

Riverside Clinical Research

Edgewater, Florida, 32132, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Dorshow RB, Debreczeny MP, Goldstein SL. GFR Measurement Using Transdermal Detection Methodology. J Am Soc Nephrol. 2025 Feb 7;36(8):1592-1602. doi: 10.1681/ASN.0000000639.

  PMID: 39918882 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

relmapirazin; Iohexol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

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

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 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 13, 2016
• Study Start: May 11, 2016
• Primary Completion: August 4, 2021
• Study Completion: August 4, 2021
• Last Updated: October 26, 2023
• Results First Posted: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)