Phase 2
N=234
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
Acute Kidney Injury
Bottom Line
View on ClinicalTrials.gov: NCT02772276 ↗Enrolled (actual)
234
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events — 7; 7; 2; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MB-102-- single dose of 4 µmol/kg (Drug); MB-102-- single dose of 130 mg (Drug); MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart (Drug); MB-102-- two doses of 130 mg 24 hours apart (Drug); Iohexol (Drug); QuantumLeap (Device); Radiance (Device); Brilliance (1 or 2 sensors) (Device); Brilliance (2-part sensor) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MediBeacon
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events |
7; 7; 2; 1; 1; 1 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of MB-102 |
10751.613; 11625.517; 11981.7; 12243.45; 13961.111; 14440.143 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Iohexol |
295967.742; 290172.414; 333000; 329200 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of MB-102 |
7.258; 5.862; 5.25; 5.875; 5; 6.429 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of Iohexol |
9.194; 7.069; 6.5; 6.875 | — |
| SECONDARY The Elimination Half-life of MB-102 |
130.712; 314.267; 135.821; 301.21; 123.681; 245.7 | — |
| SECONDARY The Elimination Half-life of Iohexol |
148.056; 366.529; 151.776; 347.574 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102 |
1131336.448; 2419911.379; 1211931.882; 2467846.174; 1121973.694; 2560133.925 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Iohexol |
33329159.548; 58097567.569; 36677146.278; 70005450.758 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102 |
1166655.776; 3212036.698; 1242760.175; 3045719.769; 1182254.364; 2914852.088 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Iohexol |
34688858.452; 81061044.851; 38032869.839; 90107803.206 | — |
| SECONDARY Total Plasma Clearance of MB-102 |
110.719; 51.741; 102.361; 51.322; 103.107; 44.677 | — |
| SECONDARY Total Plasma Clearance of Iohexol |
97.596; 47.418; 90.788; 45.963 | — |
| SECONDARY The Terminal Rate Constant for MB-102 |
0.006; 0.003; 0.005; 0.003; 0.006; 0.003 | — |
| SECONDARY The Terminal Rate Constant for Iohexol |
0.005; 0.002; 0.005; 0.002 | — |
| SECONDARY Renal Clearance of MB-102 |
111.396; 52.171; 104.008; 51.915; 105.144; 45.397 | — |
| SECONDARY Renal Clearance of Iohexol |
98.548; 47.909; 92.258; 46.109 | — |
| 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 |
-0.999; -0.998 | — |
| 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 |
-0.999; -0.998 | — |
| 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 |
-0.994; -0.998; -0.999; -0.997; -0.999; -1 | — |
| 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 |
-0.999; -0.998; -0.993 | — |
| SECONDARY Number of Participants With Adverse Events Related to the Use of the QuantumLeap Device |
4; 0 | — |
| SECONDARY Number of Participants With Adverse Events Related to the Use of the Radiance Device |
1; 0 | — |
| SECONDARY Number of Participants With Adverse Events Related to the Use of the Brilliance Device |
0; 0; 2; 0; 0; 0 | — |
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.
Eligibility Criteria
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 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), psychologica
Data sourced from ClinicalTrials.gov (NCT02772276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.