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

  • STATUS
    Recruiting
  • days left to enroll
    72
  • participants needed
    245
  • sponsor
    MediBeacon
Updated on 27 January 2021
immunosuppressive agents
renal impairment
kidney function tests

Summary

This study is 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.

Description

The objectives of this study are 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.

Details
Condition Renal Failure, Acute renal failure, Kidney Failure (Pediatric), Kidney Failure, acute kidney injury, acute kidney injuries
Treatment Iohexol, MB-102, QuantumLeap, Radiance, Intravenous saline flush, Brilliance, MB-102-- single dose, MB-102-- two doses
Clinical Study IdentifierNCT02772276
SponsorMediBeacon
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: acute kidney injuries or Kidney Failure (Pediatric) or Acute renal failure or Renal Failure or Kidney Failure or acute kidney injury?
Do you have any of these conditions: acute kidney injury or Kidney Failure or acute kidney injuries or Renal Failure or Acute renal failure or Kidney Failure (Pediatric)?
Do you have any of these conditions: Renal Failure or acute kidney injury or Kidney Failure or Acute renal failure or acute kidney injuries or Kidney Failure (Pediatric)?
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 sensor optimization; Normal-CKD Stage 2/Brilliance sensor validation; CKD Stage 3-5/Brilliance sensor validation; Normal-CKD Stage 2/Brilliance final algorithm and sensor; CKD Stage 3-5/Brilliance final algorithm and sensor 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
Brilliance algorithm optimization; Normal-CKD Stage 2/Brilliance sensor
optimization; Normal-CKD Stage 2/Brilliance sensor validation; and Normal-CKD
Stage 2/Brilliance final algorithm and sensor 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; CKD
Stage 3-5/Brilliance sensor validation; and CKD Stage 3-5/Brilliance final
algorithm and sensor
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
-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

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 sensor; and CKD Stage 3-5/Brilliance final algorithm and
sensor 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
Brilliance algorithm optimization; Normal-CKD Stage 2/Brilliance sensor
optimization; Normal-CKD Stage 2/Brilliance sensor validation; and Normal-CKD
Stage 2/Brilliance final algorithm and sensor 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
-5/Brilliance algorithm optimization; CKD Stage 3-5/Brilliance sensor
validation; and CKD Stage 3-5/Brilliance final algorithm and sensor 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
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