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

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 Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02772276

Enrollment

234

Registered

2016-05-13

Start date

2016-05-11

Completion date

2021-08-04

Last updated

2023-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

Glomerular Filtration Rate

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.

Detailed description

The objectives of this study were to evaluate the safety and tolerability of single and multiple doses of MB-102 in participants with normal and impaired kidney function; to determine plasma pharmacokinetics of MB-102 compared to the pharmacokinetics of iohexol in participants with normal and impaired kidney function; to demonstrate that MB-102-transdermal-fluorescence-measured glomerular filtration rate (GFR) using the optical renal function monitor (ORFM) Brilliance device is aligned with MB-102 plasma GFR; to evaluate the safety and effectiveness of the ORFM investigational medical device prototypes QuantumLeap, Radiance, and Brilliance for the non-invasive transdermal fluorescent detection of MB-102 in participants with a range of skin color types; and to determine the optimal dose of MB-102 for non-invasive measurement.

Interventions

DRUGMB-102-- single dose of 4 µmol/kg

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

DRUGMB-102-- single dose of 130 mg

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.

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

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

DRUGMB-102-- two doses of 130 mg 24 hours apart

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.

DRUGIohexol

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

DEVICEQuantumLeap

Optical Renal Function Monitor (ORFM)

DEVICERadiance

Optical Renal Function Monitor (ORFM)

DEVICEBrilliance (1 or 2 sensors)

Optical Renal Function Monitor (ORFM)

DEVICEBrilliance (2-part sensor)

Optical Renal Function Monitor (ORFM)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Main Criteria for Inclusion (Quantum Leap and Radiance device) * 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 Main Criteria for Inclusion (Brilliance device) * 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) * Are healthy as determined by medical history, with no clinically significant findings on screening and baseline physical exams, vital signs and clinical laboratory panels or conditions that could adversely impact the participant's participation or safety, conduct of the study or interfere with study assessments * Have estimated glomerular filtration rate (eGFR (Chronic kidney disease - epidemiology collaboration \[CKD-EPI\] equation) of ≥60 ml/min/1.73m\^2 (normal to Stage 2 CKD) at the time of screening * Approximately half of the participants enrolled in each cohort to have Fitzpatrick Scale Type I, II or III skin color type * Approximately half of the participants enrolled in each cohort to have Fitzpatrick Type IV, V or VI skin color type. CKD Stage 3-4/QuantumLeap * Possess stable renal function in the opinion of the PI * Have eGFR (CKD-EPI equation) of 15 - 59 mL/min/1.73m\^2 at the time of screening * Stable use of immunosuppressant medications (when applicable) * 15 participants per cohort to have Fitzpatrick Type I, II or III skin color type * 15 participants per cohort to have Fitzpatrick Type IV, V or VI skin color type CKD Stage 3-5/Radiance; CKD Stage 3-5/Brilliance algorithm optimization; CKD Stage 3-5/Brilliance sensor validation; and CKD Stage 3-5/Brilliance 1-2 sensors * Possess stable renal function as defined as the most recent historical (within 3 months) eGFR and screening eGFR differing by ≤20%. * Have eGFR (CKD-EPI equation) of \<59 mL/min/1.73m\^2 based on a historical value collected within 3 months or from the screening serum creatinine * Stable use of immunosuppressant medications (when applicable) defined as no changes in the last 30 days or expected through the follow up visits, and a prednisone dose of \<20 mg/day (or another steroid's equivalent dose) * Approximately half of the participants in each cohort to have Fitzpatrick Type I, II or III skin color type * Approximately half of the participants in each cohort to have Fitzpatrick Type IV, V or VI skin color type

Exclusion criteria

Main Criteria for Exclusion (QuantumLeap device) * 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 * Currently on Coumadin (warfarin) who have an International normalized ratio (INR) \>4 at Screening * Current history of AIDS or HIV * Hepatitis B antigen positive, or C antibody positive * Site personnel immediately associated with the study or their immediate family members * Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial * Prior enrollment and dosing in this Pilot 2 study * Significant scaring, tattoos or alterations in pigmentation on the sternum that would alter sensor readings versus other areas of the skin Additional Exclusion: Normal-CKD Stage 2/QuantumLeap • History of significant cardiovascular disease, heart failure, myocardial infarction in the past 3 months, pulmonary, hematologic, endocrine, hepatobiliary, nephrologic, immunologic, dermatologic, neurologic (including any history of stroke and/or seizure disorder), psychological, musculoskeletal disease, diagnosis of cancer with the past 2 years or deemed clinically significant or unstable by the Principal Investigator; Note: history of gallstones or kidney stones are not excluded so long as the condition is not acute within 30 days of dosing. Additional Exclusion: CKD Stage 3-4/QuantumLeap * Stage 5 CKD at the time of screening * Recent (within 3 months) significant medical condition or surgical procedure including myocardial infarction, laparoscopic procedures, or other medical inventions * Doses of prednisone greater than 10 mg/day within the last 90 days Main Criteria for Exclusion: (Radiance device) * 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 o Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post dose * Unable to have venous access placed in both arms * 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 dosing 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 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 and iohexol or other related (iodinated contrast media) products (intolerance to a drug is not considered a drug allergy) * 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 hyperthyroidism or current thyroid cancer * Have pheochromocytoma * Currently on Coumadin (warfarin) who have an INR \>4 at Screening * Current history of AIDS or HIV * Current evidence of an active Hepatitis B or C infection. If the participant is Hepatitis C antibody positive, but the hepatitis C RNA is below the level of detection, they are considered immune and may be eligible for enrollment. * Site personnel immediately associated with the study or their immediate family members * Any characteristics which, in the opinion of the investigator, makes the subject a poor candidate for participation in the clinical trial * Prior exposure to MB-102 * Significant scaring, tattoos or alterations in pigmentation on the sternum that would alter sensor readings versus other areas of the skin Main Criteria for Exclusion: (Brilliance device) * 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 o Males must be unwilling to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post dose * Unable to have venous access * 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 dosing 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 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, or MB-102 (intolerance to a drug is not considered a drug allergy) * 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 * Currently on Coumadin (warfarin) who have an INR \>4 at Screening * Current history of AIDS or HIV * Current evidence of an active Hepatitis B or C infection. If the participant is Hepatitis C antibody positive, but the hepatitis C RNA is below the level of detection, they are considered immune and may be eligible for enrollment. * Site personnel immediately associated with the study or their immediate family members * 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 that would alter sensor readings versus other areas of the skin Additional Exclusion: 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 validation; and Normal-CKD Stage 2/Brilliance (1-2 sensors) * History of significant cardiovascular disease, heart failure, myocardial infarction in the past 3 months, or NYHA class III or IV HF * Any other 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 subject at increased risk or compromise interpretability of study results. Note: a history of gallstones or kidney stones are not excluded so long as the condition is not acute within 30 days of dosing. Additional Exclusion: CKD Stage 3-5/Radiance; CKD Stage 3-5/Brilliance algorithm optimization; CKD Stage 3-5/Brilliance sensor validation; and CKD Stage 3-5/Brilliance 1-2 sensors * Recent (within 3 months) significant medical condition or surgical procedure including myocardial infarction, thoracic laparoscopic procedures, or other significant medical inventions * Received \>20 mg/day of prednisone or an equivalent dose of glucocorticoid for more than 7 days in the last 90 days prior to dosing day for an acute or chronic disorder * Currently receiving dialysis * Currently anuric

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Treatment-Emergent Adverse Events	From the time of dosing through the follow-up visit, 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.

Secondary

Countries

United States

Participant flow

Pre-assignment details

Safety Analysis Set: all participants who signed the informed consent form and received study drug

Participants by arm

Arm	Count
Normal-CKD Stage 2/QuantumLeap 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.	31
CKD Stage 3-4/QuantumLeap 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.	29
Normal-CKD Stage 2/Radiance 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.	20
CKD Stage 3-5/Radiance 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.	40
Normal-CKD Stage 2/Brilliance Algorithm Optimization 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.	9
CKD Stage 3-5/Brilliance Algorithm Optimization 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.	7
Normal-CKD Stage 2/Brilliance Sensor Optimization 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.	18
Normal-CKD Stage 2/Brilliance Sensor Validation 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.	30
CKD Stage 3-5/Brilliance Sensor Validation 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.	18
Normal-CKD Stage 2/Brilliance (1-2 Sensors) 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.	12
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) 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.	4
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102 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.	4
CKD Stage 3-5/Brilliance 1-2 Sensors 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.	12
Total	234

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008	FG009	FG010	FG011	FG012
Overall Study	Lost to Follow-up	0	0	0	0	0	0	1	0	0	0	0	0	0
Overall Study	Withdrew consent	0	0	0	0	0	0	0	1	0	0	0	0	0

Baseline characteristics

Characteristic	Normal-CKD Stage 2/QuantumLeap	Total	CKD Stage 3-5/Brilliance 1-2 Sensors	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 and Brilliance 2-part Sensor)	Normal-CKD Stage 2/Brilliance (1-2 Sensors)	CKD Stage 3-5/Brilliance Sensor Validation	Normal-CKD Stage 2/Brilliance Sensor Validation	Normal-CKD Stage 2/Brilliance Sensor Optimization	CKD Stage 3-5/Brilliance Algorithm Optimization	Normal-CKD Stage 2/Brilliance Algorithm Optimization	CKD Stage 3-5/Radiance	Normal-CKD Stage 2/Radiance	CKD Stage 3-4/QuantumLeap
Age, Continuous	40.3 years STANDARD_DEVIATION 11.78	53 years STANDARD_DEVIATION 16.7	70.3 years STANDARD_DEVIATION 9.46	42.5 years STANDARD_DEVIATION 13.72	52.3 years STANDARD_DEVIATION 14.27	47.9 years STANDARD_DEVIATION 17.7	70.9 years STANDARD_DEVIATION 8.09	39.1 years STANDARD_DEVIATION 15.38	41.6 years STANDARD_DEVIATION 15.42	66.9 years STANDARD_DEVIATION 6.67	46.9 years STANDARD_DEVIATION 13.4	61.1 years STANDARD_DEVIATION 12.93	54.7 years STANDARD_DEVIATION 13.57	58.2 years STANDARD_DEVIATION 11.76
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	15 Participants	87 Participants	4 Participants	2 Participants	2 Participants	6 Participants	1 Participants	11 Participants	7 Participants	2 Participants	4 Participants	15 Participants	7 Participants	11 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	15 Participants	144 Participants	8 Participants	2 Participants	2 Participants	6 Participants	17 Participants	19 Participants	11 Participants	5 Participants	5 Participants	25 Participants	11 Participants	18 Participants
Region of Enrollment United States	31 Participants	234 Participants	12 Participants	4 Participants	4 Participants	12 Participants	18 Participants	30 Participants	18 Participants	7 Participants	9 Participants	40 Participants	20 Participants	29 Participants
Sex: Female, Male Female	19 Participants	115 Participants	4 Participants	2 Participants	1 Participants	6 Participants	6 Participants	16 Participants	8 Participants	6 Participants	2 Participants	21 Participants	10 Participants	14 Participants
Sex: Female, Male Male	12 Participants	119 Participants	8 Participants	2 Participants	3 Participants	6 Participants	12 Participants	14 Participants	10 Participants	1 Participants	7 Participants	19 Participants	10 Participants	15 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk	EG012 affected / at risk
deaths Total, all-cause mortality	0 / 31	0 / 29	0 / 20	0 / 40	0 / 9	0 / 7	0 / 18	0 / 30	0 / 18	0 / 12	0 / 4	0 / 4	0 / 12
other Total, other adverse events	7 / 31	5 / 29	2 / 20	0 / 40	1 / 9	1 / 7	2 / 18	0 / 30	1 / 18	2 / 12	1 / 4	1 / 4	2 / 12
serious Total, serious adverse events	0 / 31	0 / 29	0 / 20	0 / 40	0 / 9	0 / 7	0 / 18	0 / 30	0 / 18	0 / 12	0 / 4	0 / 4	0 / 12

Outcome results

Primary

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.

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

Population: Safety Analysis Set: all participants who signed the informed consent form and received study drug

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Normal-CKD Stage 2/QuantumLeap	Number of Participants With Treatment-Emergent Adverse Events	7 Participants
CKD Stage 3-4/QuantumLeap	Number of Participants With Treatment-Emergent Adverse Events	7 Participants
Normal-CKD Stage 2/Radiance	Number of Participants With Treatment-Emergent Adverse Events	2 Participants
CKD Stage 3-5/Radiance	Number of Participants With Treatment-Emergent Adverse Events	1 Participants
Normal-CKD Stage 2/Brilliance Algorithm Optimization	Number of Participants With Treatment-Emergent Adverse Events	1 Participants
CKD Stage 3-5/Brilliance Algorithm Optimization	Number of Participants With Treatment-Emergent Adverse Events	1 Participants
Normal-CKD Stage 2/Brilliance Sensor Optimization	Number of Participants With Treatment-Emergent Adverse Events	2 Participants
Normal-CKD Stage 2/Brilliance Sensor Validation	Number of Participants With Treatment-Emergent Adverse Events	0 Participants
CKD Stage 3-5/Brilliance Sensor Validation	Number of Participants With Treatment-Emergent Adverse Events	1 Participants
Normal-CKD Stage 2/Brilliance (1-2 Sensors)	Number of Participants With Treatment-Emergent Adverse Events	2 Participants
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)	Number of Participants With Treatment-Emergent Adverse Events	1 Participants
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102	Number of Participants With Treatment-Emergent Adverse Events	1 Participants
CKD Stage 3-5/Brilliance 1-2 Sensors	Number of Participants With Treatment-Emergent Adverse Events	2 Participants

Secondary

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Iohexol

Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng\*min/mL) from time 0 to infinity was calculated as: AUC∞ = AUClast + LQC/λz where LQC is the predicted concentration (based on the terminal regression) at the time of the last measurable concentration.

Time frame: 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.

Population: All participants who received study drug and had no major protocol deviations. Per protocol, those in the Brilliance device group did not receive iohexol.

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Iohexol	34688858.452 ng*min/mL	Standard Deviation 9029243.5529
CKD Stage 3-4/QuantumLeap	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Iohexol	81061044.851 ng*min/mL	Standard Deviation 37977572.641
Normal-CKD Stage 2/Radiance	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Iohexol	38032869.839 ng*min/mL	Standard Deviation 11788838.136
CKD Stage 3-5/Radiance	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Iohexol	90107803.206 ng*min/mL	Standard Deviation 61220389.979

Secondary

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102

Time frame: 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.

Population: All participants who received study drug and had no major protocol deviations.

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102	1166655.776 ng*min/mL	Standard Deviation 298807.3587
CKD Stage 3-4/QuantumLeap	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102	3212036.698 ng*min/mL	Standard Deviation 1490329.1808
Normal-CKD Stage 2/Radiance	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102	1242760.175 ng*min/mL	Standard Deviation 321230.0672
CKD Stage 3-5/Radiance	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102	3045719.769 ng*min/mL	Standard Deviation 1625406.4454
Normal-CKD Stage 2/Brilliance Algorithm Optimization	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102	1182254.364 ng*min/mL	Standard Deviation 208571.1669
CKD Stage 3-5/Brilliance Algorithm Optimization	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102	2914852.088 ng*min/mL	Standard Deviation 684490.5106
Normal-CKD Stage 2/Brilliance Sensor Optimization	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102	1264462.94 ng*min/mL	Standard Deviation 333601.038
Normal-CKD Stage 2/Brilliance Sensor Validation	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102	1086390.141 ng*min/mL	Standard Deviation 287588.9895
CKD Stage 3-5/Brilliance Sensor Validation	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102	3135394.594 ng*min/mL	Standard Deviation 1051071.597
Normal-CKD Stage 2/Brilliance (1-2 Sensors)	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102	1403855.606 ng*min/mL	Standard Deviation 355269.4445
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102	1518516.431 ng*min/mL	Standard Deviation 106177.2201
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102	1340051.2 ng*min/mL	Standard Deviation 332392.6494
CKD Stage 3-5/Brilliance 1-2 Sensors	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102	3844963.027 ng*min/mL	Standard Deviation 1630799.1909

Secondary

Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Iohexol

Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng\*min/mL) was be estimated from time 0 to the last measurable concentration using noncompartmental analyses.

Time frame: 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.

Population: All participants who received study drug and had no major protocol deviations. Per protocol, those in the Brilliance device group did not receive iohexol.

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Iohexol	33329159.548 ng*min/mL	Standard Deviation 7909842.8639
CKD Stage 3-4/QuantumLeap	Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Iohexol	58097567.569 ng*min/mL	Standard Deviation 15177720.419
Normal-CKD Stage 2/Radiance	Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Iohexol	36677146.278 ng*min/mL	Standard Deviation 10789963.956
CKD Stage 3-5/Radiance	Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Iohexol	70005450.758 ng*min/mL	Standard Deviation 30243153.821

Secondary

Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102

Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng\*min/mL) was be estimated from time 0 to the last measurable concentration using noncompartmental analyses.

Time frame: 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.

Population: All participants who received study drug and had no major protocol deviations.

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102	1131336.448 ng*min/mL	Standard Deviation 254801.4255
CKD Stage 3-4/QuantumLeap	Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102	2419911.379 ng*min/mL	Standard Deviation 708114.7104
Normal-CKD Stage 2/Radiance	Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102	1211931.882 ng*min/mL	Standard Deviation 296491.1469
CKD Stage 3-5/Radiance	Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102	2467846.174 ng*min/mL	Standard Deviation 843410.9665
Normal-CKD Stage 2/Brilliance Algorithm Optimization	Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102	1121973.694 ng*min/mL	Standard Deviation 190118.8591
CKD Stage 3-5/Brilliance Algorithm Optimization	Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102	2560133.925 ng*min/mL	Standard Deviation 519858.5738
Normal-CKD Stage 2/Brilliance Sensor Optimization	Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102	1235178.035 ng*min/mL	Standard Deviation 310587.5336
Normal-CKD Stage 2/Brilliance Sensor Validation	Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102	1072786.062 ng*min/mL	Standard Deviation 281421.3481
CKD Stage 3-5/Brilliance Sensor Validation	Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102	2476458.456 ng*min/mL	Standard Deviation 543445.259
Normal-CKD Stage 2/Brilliance (1-2 Sensors)	Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102	1384887.303 ng*min/mL	Standard Deviation 345784.1469
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)	Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102	1488269.994 ng*min/mL	Standard Deviation 108723.6082
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102	Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102	1316506.556 ng*min/mL	Standard Deviation 314196.0436
CKD Stage 3-5/Brilliance 1-2 Sensors	Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102	3678411.381 ng*min/mL	Standard Deviation 1344727.8138

Secondary

Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With CKD Stage 3-4 Renal Function

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) and 960, 1440, 1920, 2400, and 2880 (±30 min) minutes post dose, and were analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the Brilliance device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the Brilliance device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.

Time frame: Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) and 960, 1440, 1920, 2400, and 2880 (±30 min) minutes post dose

Population: All participants who received study drug and had no major protocol deviations

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With CKD Stage 3-4 Renal Function	-0.999 Coefficient of determination, r-squared	Standard Deviation 0.0015
CKD Stage 3-4/QuantumLeap	Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With CKD Stage 3-4 Renal Function	-0.998 Coefficient of determination, r-squared	Standard Deviation 0.0018
Normal-CKD Stage 2/Radiance	Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With CKD Stage 3-4 Renal Function	-0.993 Coefficient of determination, r-squared	Standard Deviation 0.0193

Secondary

Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With Normal-CKD Stage 2 Renal Function

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, and 480 minutes post dose, and were analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the Brilliance device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the Brilliance device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.

Time frame: Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, and 480 minutes post dose

Population: All participants who received study drug and had no major protocol deviations

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With Normal-CKD Stage 2 Renal Function	-0.994 Coefficient of determination, r-squared	Standard Deviation 0.0092
CKD Stage 3-4/QuantumLeap	Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With Normal-CKD Stage 2 Renal Function	-0.998 Coefficient of determination, r-squared	Standard Deviation 0.0026
Normal-CKD Stage 2/Radiance	Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With Normal-CKD Stage 2 Renal Function	-0.999 Coefficient of determination, r-squared	Standard Deviation 0.0015
CKD Stage 3-5/Radiance	Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With Normal-CKD Stage 2 Renal Function	-0.997 Coefficient of determination, r-squared	Standard Deviation 0.0037
Normal-CKD Stage 2/Brilliance Algorithm Optimization	Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With Normal-CKD Stage 2 Renal Function	-0.999 Coefficient of determination, r-squared	Standard Deviation 0.0015
CKD Stage 3-5/Brilliance Algorithm Optimization	Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With Normal-CKD Stage 2 Renal Function	-1 Coefficient of determination, r-squared	Standard Deviation 0.0001

Secondary

Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Quantum Leap Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase

Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the QuantumLeap device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the QuantumLeap device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.

Time frame: Pre-dose (time 0) 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

Population: All participants who received study drug and had no major protocol deviations

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Quantum Leap Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase	-0.999 Coefficient of determination, r-squared	Standard Deviation 0.0009
CKD Stage 3-4/QuantumLeap	Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Quantum Leap Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase	-0.998 Coefficient of determination, r-squared	Standard Deviation 0.0028

Secondary

Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Radiance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase

Blood samples were collected pre-dose (time 0) and at 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, and will be analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the Radiance device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the Radiance device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.

Time frame: Pre-dose (time 0) 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

Population: All participants who received study drug and had no major protocol deviations

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Radiance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase	-0.999 Coefficient of determination, r-squared	Standard Deviation 0.001
CKD Stage 3-4/QuantumLeap	Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Radiance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase	-0.998 Coefficient of determination, r-squared	Standard Deviation 0.0033

Secondary

Maximum Plasma Concentration (Cmax) of Iohexol

Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.

Time frame: 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.

Population: All participants who received study drug and had no major protocol deviations. Per protocol, those in the Brilliance device group did not receive iohexol.

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	Maximum Plasma Concentration (Cmax) of Iohexol	295967.742 ng/mL	Standard Deviation 71088.9039
CKD Stage 3-4/QuantumLeap	Maximum Plasma Concentration (Cmax) of Iohexol	290172.414 ng/mL	Standard Deviation 74285.6788
Normal-CKD Stage 2/Radiance	Maximum Plasma Concentration (Cmax) of Iohexol	333000 ng/mL	Standard Deviation 70799.9405
CKD Stage 3-5/Radiance	Maximum Plasma Concentration (Cmax) of Iohexol	329200 ng/mL	Standard Deviation 98658.229

Secondary

Maximum Plasma Concentration (Cmax) of MB-102

Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.

Time frame: 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.

Population: All participants who received study drug and had no major protocol deviations.

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	Maximum Plasma Concentration (Cmax) of MB-102	10751.613 ng/mL	Standard Deviation 2279.3699
CKD Stage 3-4/QuantumLeap	Maximum Plasma Concentration (Cmax) of MB-102	11625.517 ng/mL	Standard Deviation 2491.4304
Normal-CKD Stage 2/Radiance	Maximum Plasma Concentration (Cmax) of MB-102	11981.7 ng/mL	Standard Deviation 2659.9568
CKD Stage 3-5/Radiance	Maximum Plasma Concentration (Cmax) of MB-102	12243.45 ng/mL	Standard Deviation 2563.5734
Normal-CKD Stage 2/Brilliance Algorithm Optimization	Maximum Plasma Concentration (Cmax) of MB-102	13961.111 ng/mL	Standard Deviation 3326.5064
CKD Stage 3-5/Brilliance Algorithm Optimization	Maximum Plasma Concentration (Cmax) of MB-102	14440.143 ng/mL	Standard Deviation 3049.767
Normal-CKD Stage 2/Brilliance Sensor Optimization	Maximum Plasma Concentration (Cmax) of MB-102	13747.739 ng/mL	Standard Deviation 2985.4673
Normal-CKD Stage 2/Brilliance Sensor Validation	Maximum Plasma Concentration (Cmax) of MB-102	13453.74 ng/mL	Standard Deviation 3886.9335
CKD Stage 3-5/Brilliance Sensor Validation	Maximum Plasma Concentration (Cmax) of MB-102	13039.944 ng/mL	Standard Deviation 3819.8448
Normal-CKD Stage 2/Brilliance (1-2 Sensors)	Maximum Plasma Concentration (Cmax) of MB-102	13015.833 ng/mL	Standard Deviation 2314.2462
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)	Maximum Plasma Concentration (Cmax) of MB-102	15650 ng/mL	Standard Deviation 4023.6799
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102	Maximum Plasma Concentration (Cmax) of MB-102	13125 ng/mL	Standard Deviation 2818.2441
CKD Stage 3-5/Brilliance 1-2 Sensors	Maximum Plasma Concentration (Cmax) of MB-102	11665 ng/mL	Standard Deviation 3637.8803

Secondary

Number of Participants With Adverse Events Related to the Use of the Brilliance Device

The number of participants with adverse events related to the use of the Brilliance device was documented.

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

Population: Safety Analysis Set: all participants who signed the informed consent form and received study drug

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Normal-CKD Stage 2/QuantumLeap	Number of Participants With Adverse Events Related to the Use of the Brilliance Device	0 Participants
CKD Stage 3-4/QuantumLeap	Number of Participants With Adverse Events Related to the Use of the Brilliance Device	0 Participants
Normal-CKD Stage 2/Radiance	Number of Participants With Adverse Events Related to the Use of the Brilliance Device	2 Participants
CKD Stage 3-5/Radiance	Number of Participants With Adverse Events Related to the Use of the Brilliance Device	0 Participants
Normal-CKD Stage 2/Brilliance Algorithm Optimization	Number of Participants With Adverse Events Related to the Use of the Brilliance Device	0 Participants
CKD Stage 3-5/Brilliance Algorithm Optimization	Number of Participants With Adverse Events Related to the Use of the Brilliance Device	0 Participants
Normal-CKD Stage 2/Brilliance Sensor Optimization	Number of Participants With Adverse Events Related to the Use of the Brilliance Device	0 Participants
Normal-CKD Stage 2/Brilliance Sensor Validation	Number of Participants With Adverse Events Related to the Use of the Brilliance Device	0 Participants
CKD Stage 3-5/Brilliance Sensor Validation	Number of Participants With Adverse Events Related to the Use of the Brilliance Device	0 Participants

Secondary

Number of Participants With Adverse Events Related to the Use of the QuantumLeap Device

The number of participants with adverse events related to the use of the QuantumLeap device was documented.

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

Population: Safety Analysis Set: all participants who signed the informed consent form and received study drug

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Normal-CKD Stage 2/QuantumLeap	Number of Participants With Adverse Events Related to the Use of the QuantumLeap Device	4 Participants
CKD Stage 3-4/QuantumLeap	Number of Participants With Adverse Events Related to the Use of the QuantumLeap Device	0 Participants

Secondary

Number of Participants With Adverse Events Related to the Use of the Radiance Device

The number of participants with adverse events related to the use of the Radiance device was documented.

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

Population: Safety Analysis Set: all participants who signed the informed consent form and received study drug

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Normal-CKD Stage 2/QuantumLeap	Number of Participants With Adverse Events Related to the Use of the Radiance Device	1 Participants
CKD Stage 3-4/QuantumLeap	Number of Participants With Adverse Events Related to the Use of the Radiance Device	0 Participants

Secondary

Renal Clearance of Iohexol

Urine samples were collected pre-dose (time 0) and 5 mL urine samples were collected each time the subject voided. The total volume of urine excreted was recorded until 12 hours post-dose, and was analyzed using validated analytical methods. Renal clearance (the volume of plasma cleared of the drug by the kidneys over time) was calculated as: CLr = Ae/ AUClast, where Ae is the cumulative amount of analyte excreted in urine over the sampling interval.

Time frame: Pre-dose and each time the participant voids up to 720 minutes post dose

Population: All participants who received study drug and had no major protocol deviations. Per protocol, those in the Brilliance device group did not receive iohexol.

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	Renal Clearance of Iohexol	98.548 mL/minute	Standard Deviation 22.5239
CKD Stage 3-4/QuantumLeap	Renal Clearance of Iohexol	47.909 mL/minute	Standard Deviation 20.1816
Normal-CKD Stage 2/Radiance	Renal Clearance of Iohexol	92.258 mL/minute	Standard Deviation 26.5401
CKD Stage 3-5/Radiance	Renal Clearance of Iohexol	46.109 mL/minute	Standard Deviation 19.4391

Secondary

Renal Clearance of MB-102

Time frame: Pre-dose and each time the participant voids up to 720 minutes post dose

Population: All participants who received study drug and had no major protocol deviations.

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	Renal Clearance of MB-102	111.396 mL/minute	Standard Deviation 27.9973
CKD Stage 3-4/QuantumLeap	Renal Clearance of MB-102	52.171 mL/minute	Standard Deviation 21.825
Normal-CKD Stage 2/Radiance	Renal Clearance of MB-102	104.008 mL/minute	Standard Deviation 32.3622
CKD Stage 3-5/Radiance	Renal Clearance of MB-102	51.915 mL/minute	Standard Deviation 26.3905
Normal-CKD Stage 2/Brilliance Algorithm Optimization	Renal Clearance of MB-102	105.144 mL/minute	Standard Deviation 19.2031
CKD Stage 3-5/Brilliance Algorithm Optimization	Renal Clearance of MB-102	45.397 mL/minute	Standard Deviation 14.1766
Normal-CKD Stage 2/Brilliance Sensor Optimization	Renal Clearance of MB-102	99.072 mL/minute	Standard Deviation 19.0079
Normal-CKD Stage 2/Brilliance Sensor Validation	Renal Clearance of MB-102	120.452 mL/minute	Standard Deviation 40.0937
CKD Stage 3-5/Brilliance Sensor Validation	Renal Clearance of MB-102	42.51 mL/minute	Standard Deviation 12.9745
Normal-CKD Stage 2/Brilliance (1-2 Sensors)	Renal Clearance of MB-102	109.924 mL/minute	Standard Deviation 35.5733
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)	Renal Clearance of MB-102	88.795 mL/minute	Standard Deviation 3.2184
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102	Renal Clearance of MB-102	103.774 mL/minute	Standard Deviation 24.9108
CKD Stage 3-5/Brilliance 1-2 Sensors	Renal Clearance of MB-102	38.373 mL/minute	Standard Deviation 13.0747

Secondary

The Elimination Half-life of Iohexol

Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. The elimination half-life (the time required for the concentration of the drug to reach half of its original value) was calculated as t1/2 λz= ln(2)/ λz.

Time frame: 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.

Population: All participants who received study drug and had no major protocol deviations. Per protocol, those in the Brilliance device group did not receive iohexol.

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	The Elimination Half-life of Iohexol	148.056 minutes	Standard Deviation 38.2236
CKD Stage 3-4/QuantumLeap	The Elimination Half-life of Iohexol	366.529 minutes	Standard Deviation 191.4136
Normal-CKD Stage 2/Radiance	The Elimination Half-life of Iohexol	151.776 minutes	Standard Deviation 31.4044
CKD Stage 3-5/Radiance	The Elimination Half-life of Iohexol	347.574 minutes	Standard Deviation 214.8895

Secondary

The Elimination Half-life of MB-102

Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. The elimination half-life (the time required for the concentration of the drug to reach half of its original value) was calculated as t1/2 λz= ln(2)/ λz.

Time frame: 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.

Population: All participants who received study drug and had no major protocol deviations.

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	The Elimination Half-life of MB-102	130.712 minutes	Standard Deviation 33.5894
CKD Stage 3-4/QuantumLeap	The Elimination Half-life of MB-102	314.267 minutes	Standard Deviation 151.5375
Normal-CKD Stage 2/Radiance	The Elimination Half-life of MB-102	135.821 minutes	Standard Deviation 26.0772
CKD Stage 3-5/Radiance	The Elimination Half-life of MB-102	301.21 minutes	Standard Deviation 183.0147
Normal-CKD Stage 2/Brilliance Algorithm Optimization	The Elimination Half-life of MB-102	123.681 minutes	Standard Deviation 25.4325
CKD Stage 3-5/Brilliance Algorithm Optimization	The Elimination Half-life of MB-102	245.7 minutes	Standard Deviation 51.3774
Normal-CKD Stage 2/Brilliance Sensor Optimization	The Elimination Half-life of MB-102	140.176 minutes	Standard Deviation 22.2139
Normal-CKD Stage 2/Brilliance Sensor Validation	The Elimination Half-life of MB-102	122.86 minutes	Standard Deviation 14.6245
CKD Stage 3-5/Brilliance Sensor Validation	The Elimination Half-life of MB-102	305.944 minutes	Standard Deviation 105.6855
Normal-CKD Stage 2/Brilliance (1-2 Sensors)	The Elimination Half-life of MB-102	126.049 minutes	Standard Deviation 20.65
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)	The Elimination Half-life of MB-102	147.117 minutes	Standard Deviation 23.779
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102	The Elimination Half-life of MB-102	127.842 minutes	Standard Deviation 22.9881
CKD Stage 3-5/Brilliance 1-2 Sensors	The Elimination Half-life of MB-102	440.488 minutes	Standard Deviation 294.5741

Secondary

The Terminal Rate Constant for Iohexol

Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. The terminal rate constant (λz) was determined by linear regression of the terminal linear phase of the log plasma concentration-time profile.

Time frame: 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.

Population: All participants who received study drug and had no major protocol deviations. Per protocol, those in the Brilliance device group did not receive iohexol.

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	The Terminal Rate Constant for Iohexol	0.005 1/minutes	Standard Deviation 0.001
CKD Stage 3-4/QuantumLeap	The Terminal Rate Constant for Iohexol	0.002 1/minutes	Standard Deviation 0.0009
Normal-CKD Stage 2/Radiance	The Terminal Rate Constant for Iohexol	0.005 1/minutes	Standard Deviation 0.0009
CKD Stage 3-5/Radiance	The Terminal Rate Constant for Iohexol	0.002 1/minutes	Standard Deviation 0.0008

Secondary

The Terminal Rate Constant for MB-102

Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. The terminal rate constant (λz) was determined by linear regression of the terminal linear phase of the log plasma concentration-time profile.

Time frame: 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.

Population: All participants who received study drug and had no major protocol deviations.

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	The Terminal Rate Constant for MB-102	0.006 1/minutes	Standard Deviation 0.0012
CKD Stage 3-4/QuantumLeap	The Terminal Rate Constant for MB-102	0.003 1/minutes	Standard Deviation 0.001
Normal-CKD Stage 2/Radiance	The Terminal Rate Constant for MB-102	0.005 1/minutes	Standard Deviation 0.0009
CKD Stage 3-5/Radiance	The Terminal Rate Constant for MB-102	0.003 1/minutes	Standard Deviation 0.0012
Normal-CKD Stage 2/Brilliance Algorithm Optimization	The Terminal Rate Constant for MB-102	0.006 1/minutes	Standard Deviation 0.001
CKD Stage 3-5/Brilliance Algorithm Optimization	The Terminal Rate Constant for MB-102	0.003 1/minutes	Standard Deviation 0.0007
Normal-CKD Stage 2/Brilliance Sensor Optimization	The Terminal Rate Constant for MB-102	0.005 1/minutes	Standard Deviation 0.0008
Normal-CKD Stage 2/Brilliance Sensor Validation	The Terminal Rate Constant for MB-102	0.006 1/minutes	Standard Deviation 0.0006
CKD Stage 3-5/Brilliance Sensor Validation	The Terminal Rate Constant for MB-102	0.003 1/minutes	Standard Deviation 0.0009
Normal-CKD Stage 2/Brilliance (1-2 Sensors)	The Terminal Rate Constant for MB-102	0.006 1/minutes	Standard Deviation 0.0009
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)	The Terminal Rate Constant for MB-102	0.005 1/minutes	Standard Deviation 0.0008
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102	The Terminal Rate Constant for MB-102	0.006 1/minutes	Standard Deviation 0.0009
CKD Stage 3-5/Brilliance 1-2 Sensors	The Terminal Rate Constant for MB-102	0.002 1/minutes	Standard Deviation 0.0007

Secondary

Time to Maximum Plasma Concentration (Tmax) of Iohexol

Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in minutes) was directly determined from the concentration-time data.

Time frame: 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.

Population: All participants who received study drug and had no major protocol deviations. Per protocol, those in the Brilliance device group did not receive iohexol.

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	Time to Maximum Plasma Concentration (Tmax) of Iohexol	9.194 minutes	Standard Deviation 5.338
CKD Stage 3-4/QuantumLeap	Time to Maximum Plasma Concentration (Tmax) of Iohexol	7.069 minutes	Standard Deviation 3.1388
Normal-CKD Stage 2/Radiance	Time to Maximum Plasma Concentration (Tmax) of Iohexol	6.5 minutes	Standard Deviation 2.3508
CKD Stage 3-5/Radiance	Time to Maximum Plasma Concentration (Tmax) of Iohexol	6.875 minutes	Standard Deviation 2.7003

Secondary

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

Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in minutes) was directly determined from the concentration-time data.

Time frame: 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.

Population: All participants who received study drug and had no major protocol deviations.

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	Time to Maximum Plasma Concentration (Tmax) of MB-102	7.258 minutes	Standard Deviation 5.2976
CKD Stage 3-4/QuantumLeap	Time to Maximum Plasma Concentration (Tmax) of MB-102	5.862 minutes	Standard Deviation 2.341
Normal-CKD Stage 2/Radiance	Time to Maximum Plasma Concentration (Tmax) of MB-102	5.25 minutes	Standard Deviation 1.118
CKD Stage 3-5/Radiance	Time to Maximum Plasma Concentration (Tmax) of MB-102	5.875 minutes	Standard Deviation 2.2325
Normal-CKD Stage 2/Brilliance Algorithm Optimization	Time to Maximum Plasma Concentration (Tmax) of MB-102	5 minutes	Standard Deviation 0
CKD Stage 3-5/Brilliance Algorithm Optimization	Time to Maximum Plasma Concentration (Tmax) of MB-102	6.429 minutes	Standard Deviation 2.4398
Normal-CKD Stage 2/Brilliance Sensor Optimization	Time to Maximum Plasma Concentration (Tmax) of MB-102	6.111 minutes	Standard Deviation 2.7416
Normal-CKD Stage 2/Brilliance Sensor Validation	Time to Maximum Plasma Concentration (Tmax) of MB-102	5.167 minutes	Standard Deviation 0.9129
CKD Stage 3-5/Brilliance Sensor Validation	Time to Maximum Plasma Concentration (Tmax) of MB-102	12.222 minutes	Standard Deviation 27.0197
Normal-CKD Stage 2/Brilliance (1-2 Sensors)	Time to Maximum Plasma Concentration (Tmax) of MB-102	5 minutes	Standard Deviation 0
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)	Time to Maximum Plasma Concentration (Tmax) of MB-102	5 minutes	Standard Deviation 0
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102	Time to Maximum Plasma Concentration (Tmax) of MB-102	5 minutes	Standard Deviation 0
CKD Stage 3-5/Brilliance 1-2 Sensors	Time to Maximum Plasma Concentration (Tmax) of MB-102	25 minutes	Standard Deviation 67.7227

Secondary

Total Plasma Clearance of Iohexol

Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. Total plasma clearance (the volume of plasma cleared of the drug over time) was calculated as: Clp = Dose/ AUC∞.

Time frame: 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.

Population: All participants who received study drug and had no major protocol deviations. Per protocol, those in the Brilliance device group did not receive iohexol.

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	Total Plasma Clearance of Iohexol	97.596 mL/minute	Standard Deviation 22.6026
CKD Stage 3-4/QuantumLeap	Total Plasma Clearance of Iohexol	47.418 mL/minute	Standard Deviation 19.9867
Normal-CKD Stage 2/Radiance	Total Plasma Clearance of Iohexol	90.788 mL/minute	Standard Deviation 25.7641
CKD Stage 3-5/Radiance	Total Plasma Clearance of Iohexol	45.963 mL/minute	Standard Deviation 19.1755

Secondary

Total Plasma Clearance of MB-102

Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. Total plasma clearance (the volume of plasma cleared of the drug over time) was calculated as: Clp = Dose/ AUC∞.

Time frame: 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.

Population: All participants who received study drug and had no major protocol deviations.

Arm	Measure	Value (MEAN)	Dispersion
Normal-CKD Stage 2/QuantumLeap	Total Plasma Clearance of MB-102	110.719 mL/minute	Standard Deviation 28.2476
CKD Stage 3-4/QuantumLeap	Total Plasma Clearance of MB-102	51.741 mL/minute	Standard Deviation 21.4424
Normal-CKD Stage 2/Radiance	Total Plasma Clearance of MB-102	102.361 mL/minute	Standard Deviation 31.8835
CKD Stage 3-5/Radiance	Total Plasma Clearance of MB-102	51.322 mL/minute	Standard Deviation 26.2932
Normal-CKD Stage 2/Brilliance Algorithm Optimization	Total Plasma Clearance of MB-102	103.107 mL/minute	Standard Deviation 17.1532
CKD Stage 3-5/Brilliance Algorithm Optimization	Total Plasma Clearance of MB-102	44.677 mL/minute	Standard Deviation 13.798
Normal-CKD Stage 2/Brilliance Sensor Optimization	Total Plasma Clearance of MB-102	97.496 mL/minute	Standard Deviation 18.6913
Normal-CKD Stage 2/Brilliance Sensor Validation	Total Plasma Clearance of MB-102	117.913 mL/minute	Standard Deviation 39.4472
CKD Stage 3-5/Brilliance Sensor Validation	Total Plasma Clearance of MB-102	42.838 mL/minute	Standard Deviation 13.1284
Normal-CKD Stage 2/Brilliance (1-2 Sensors)	Total Plasma Clearance of MB-102	99.216 mL/minute	Standard Deviation 33.0196
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)	Total Plasma Clearance of MB-102	84.29 mL/minute	Standard Deviation 5.0376
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102	Total Plasma Clearance of MB-102	97.741 mL/minute	Standard Deviation 23.5163
CKD Stage 3-5/Brilliance 1-2 Sensors	Total Plasma Clearance of MB-102	38.736 mL/minute	Standard Deviation 13.87

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Measure	Time frame	Description
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.	Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.
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.	Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in minutes) was directly determined from the concentration-time data.
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.	Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in minutes) was directly determined from the concentration-time data.
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.	Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. The elimination half-life (the time required for the concentration of the drug to reach half of its original value) was calculated as t1/2 λz= ln(2)/ λz.
The Elimination Half-life 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.	Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. The elimination half-life (the time required for the concentration of the drug to reach half of its original value) was calculated as t1/2 λz= ln(2)/ λz.
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for 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.	Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng\*min/mL) was be estimated from time 0 to the last measurable concentration using noncompartmental analyses.
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for 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.	Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng\*min/mL) was be estimated from time 0 to the last measurable concentration using noncompartmental analyses.
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for 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.	Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng\*min/mL) from time 0 to infinity was calculated as: AUC∞ = AUClast + LQC/λz where LQC is the predicted concentration (based on the terminal regression) at the time of the last measurable concentration.
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for 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.	Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng\*min/mL) from time 0 to infinity was calculated as: AUC∞ = AUClast + LQC/λz where LQC is the predicted concentration (based on the terminal regression) at the time of the last measurable concentration.
Total Plasma Clearance 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.	Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. Total plasma clearance (the volume of plasma cleared of the drug over time) was calculated as: Clp = Dose/ AUC∞.
Total Plasma Clearance 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.	Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. Total plasma clearance (the volume of plasma cleared of the drug over time) was calculated as: Clp = Dose/ AUC∞.
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.	Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.
The Terminal Rate Constant for 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.	Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. The terminal rate constant (λz) was determined by linear regression of the terminal linear phase of the log plasma concentration-time profile.
Renal Clearance of MB-102	Pre-dose and each time the participant voids up to 720 minutes post dose	Urine samples were collected pre-dose (time 0) and 5 mL urine samples were collected each time the subject voided. The total volume of urine excreted was recorded until 12 hours post-dose, and was analyzed using validated analytical methods. Renal clearance (the volume of plasma cleared of the drug by the kidneys over time) was calculated as: CLr = Ae/ AUClast, where Ae is the cumulative amount of analyte excreted in urine over the sampling interval.
Renal Clearance of Iohexol	Pre-dose and each time the participant voids up to 720 minutes post dose	Urine samples were collected pre-dose (time 0) and 5 mL urine samples were collected each time the subject voided. The total volume of urine excreted was recorded until 12 hours post-dose, and was analyzed using validated analytical methods. Renal clearance (the volume of plasma cleared of the drug by the kidneys over time) was calculated as: CLr = Ae/ AUClast, where Ae is the cumulative amount of analyte excreted in urine over the sampling interval.
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Quantum Leap Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase	Pre-dose (time 0) 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	Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the QuantumLeap device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the QuantumLeap device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Radiance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase	Pre-dose (time 0) 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	Blood samples were collected pre-dose (time 0) and at 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, and will be analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the Radiance device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the Radiance device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With Normal-CKD Stage 2 Renal Function	Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, and 480 minutes post dose	Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, and 480 minutes post dose, and were analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the Brilliance device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the Brilliance device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With CKD Stage 3-4 Renal Function	Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) and 960, 1440, 1920, 2400, and 2880 (±30 min) minutes post dose	Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) and 960, 1440, 1920, 2400, and 2880 (±30 min) minutes post dose, and were analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the Brilliance device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the Brilliance device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.
Number of Participants With Adverse Events Related to the Use of the QuantumLeap Device	From the time of dosing through the follow-up visit, up to 10 days	The number of participants with adverse events related to the use of the QuantumLeap device was documented.
Number of Participants With Adverse Events Related to the Use of the Radiance Device	From the time of dosing through the follow-up visit, up to 10 days	The number of participants with adverse events related to the use of the Radiance device was documented.
Number of Participants With Adverse Events Related to the Use of the Brilliance Device	From the time of dosing through the follow-up visit, up to 10 days	The number of participants with adverse events related to the use of the Brilliance device was documented.
The Terminal Rate Constant for 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.	Blood samples were collected pre-dose (time 0) and at 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, and were analyzed using validated analytical methods. The terminal rate constant (λz) was determined by linear regression of the terminal linear phase of the log plasma concentration-time profile.

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

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Participants With Treatment-Emergent Adverse Events

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Iohexol

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102

Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Iohexol

Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102

Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With CKD Stage 3-4 Renal Function

Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With Normal-CKD Stage 2 Renal Function

Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Quantum Leap Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase

Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Radiance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase

Maximum Plasma Concentration (Cmax) of Iohexol

Maximum Plasma Concentration (Cmax) of MB-102

Number of Participants With Adverse Events Related to the Use of the Brilliance Device

Number of Participants With Adverse Events Related to the Use of the QuantumLeap Device

Number of Participants With Adverse Events Related to the Use of the Radiance Device

Renal Clearance of Iohexol

Renal Clearance of MB-102

The Elimination Half-life of Iohexol

The Elimination Half-life of MB-102

The Terminal Rate Constant for Iohexol

The Terminal Rate Constant for MB-102

Time to Maximum Plasma Concentration (Tmax) of Iohexol

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

Total Plasma Clearance of Iohexol

Total Plasma Clearance of MB-102