Eligibility Details:
Inclusion Criteria:
- Normal-CKD Stage 2/QuantumLeap; CKD Stage 3-4/QuantumLeap; Normal-CKD Stage
2/Radiance; and CKD Stage 3-5/Radiance groups: Age ≥ 22 years
- Normal-CKD Stage 2/Brilliance algorithm optimization; CKD Stage 3-5/Brilliance
algorithm optimization; Normal-CKD Stage 2/Brilliance final algorithm; and CKD Stage
3-5/Brilliance final algorithm groups: Age ≥ 18 years
- Female participants must not be of child-bearing potential or willing to use
study-designated contraception methods from screening through the follow-up visit
- Males must be willing to practice abstinence or utilize adequate contraception from
dosing day to at least 7 days post-dose
- 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; and Normal-CKD
Stage 2/Brilliance final algorithm groups:
- 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
- eGFR (CKD-EPI equation) of ≥60 mL/min/1.73m^2 (normal to Stage 2 CKD) at the time of
screening
CKD Stage 3-4/QuantumLeap group:
- Stable renal function in the opinion of the PI
- 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; and CKD Stage
3-5/Brilliance final algorithm groups:
- Possess stable renal function as defined as the most recent historical (within 3
months) eGFR and screening eGFR differing by ≤20%.
- 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)
Exclusion Criteria (Normal-CKD Stage 2/QuantumLeap and CKD Stage 3-4/QuantumLeap groups):
- 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
Principal Investigator, could contraindicate the subject's participation in this study
- Subjects 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 OTC medications
- 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 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 subject a
poor candidate for participation in the clinical trial
- Prior enrollment and dosing in this Pilot 2 study
- Significant scarring, tattoos or alterations in pigmentation on the sternum that would
alter sensor readings versus other areas of the skin
Additional Exclusion Criteria: (Normal-CKD Stage 2/QuantumLeap group):
- 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 Criteria (CKD Stage 3-4/QuantumLeap group):
- 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
Exclusion Criteria (Normal-CKD Stage 2/Radiance and CKD Stage 3-5/Radiance groups):
- 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
• 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, MB102 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 subject 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 scarring, tattoos or alterations in pigmentation on the sternum that would
alter sensor readings versus other areas of the skin
Exclusion Criteria (Normal-CKD Stage 2/Brilliance algorithm optimization; CKD Stage
3-5/Brilliance algorithm optimization; Normal-CKD Stage 2/Brilliance final algorithm; and
CKD Stage 3-5/Brilliance final algorithm groups):
- 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
• 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
- 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 subject is Hepatitis
C antibody positive, but the hepatitis C RNA is below the level of detection, they are
considered immune and are 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 scarring, tattoos or alterations in pigmentation on the sternum that would
alter sensor readings versus other areas of the skin
Additional Exclusion Criteria: (Normal-CKD Stage 2/Radiance; Normal-CKD Stage 2/Brilliance
algorithm optimization; Normal-CKD Stage 2/Brilliance sensor optimization; and Normal-CKD
Stage 2/Brilliance final algorithm groups):
- 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 subjects' 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 Criteria: (CKD Stage 3-5/Radiance; CKD Stage 3-5/Brilliance algorithm
optimization; and CKD Stage 3-5/Brilliance final algorithm groups):
- 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
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
