Status and phase
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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
INCLUSION CRITERIA
Main Criteria for Inclusion (Quantum Leap and Radiance device)
Age > 22 years - male or female
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
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)
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)
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
EXCLUSION CRITERIA
Main Criteria for Exclusion (QuantumLeap device)
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
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)
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
Primary purpose
Allocation
Interventional model
Masking
234 participants in 13 patient groups
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Data sourced from clinicaltrials.gov
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