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
CompletedPhase 2Results postedLast updated 26 October 2023
What this trial tests
Phase 2 trial testing MB-102-- single dose of 4 µmol/kg in Acute Kidney Injury in 234 participants. Completed in 4 August 2021.
18 and older, any sex, with Acute Kidney Injury. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-Emergent Adverse EventsPrimary· 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.
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)
1
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102
1
Maximum Plasma Concentration (Cmax) of MB-102Secondary· 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.
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)
15650
± 4023.6799
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102
13125
± 2818.2441
Maximum Plasma Concentration (Cmax) of IohexolSecondary· 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.
Group
Value
95% CI
Normal-CKD Stage 2/QuantumLeap
295967.742
± 71088.9039
CKD Stage 3-4/QuantumLeap
290172.414
± 74285.6788
Normal-CKD Stage 2/Radiance
333000
± 70799.9405
CKD Stage 3-5/Radiance
329200
± 98658.229
Time to Maximum Plasma Concentration (Tmax) of MB-102Secondary· 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.
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)
5
± 0
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102
5
± 0
Time to Maximum Plasma Concentration (Tmax) of IohexolSecondary· 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.
Group
Value
95% CI
Normal-CKD Stage 2/QuantumLeap
9.194
± 5.338
CKD Stage 3-4/QuantumLeap
7.069
± 3.1388
Normal-CKD Stage 2/Radiance
6.5
± 2.3508
CKD Stage 3-5/Radiance
6.875
± 2.7003
The Elimination Half-life of MB-102Secondary· 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.
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)
147.117
± 23.779
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102
127.842
± 22.9881
The Elimination Half-life of IohexolSecondary· 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.
Group
Value
95% CI
Normal-CKD Stage 2/QuantumLeap
148.056
± 38.2236
CKD Stage 3-4/QuantumLeap
366.529
± 191.4136
Normal-CKD Stage 2/Radiance
151.776
± 31.4044
CKD Stage 3-5/Radiance
347.574
± 214.8895
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102Secondary· 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.
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)
1488269.994
± 108723.6082
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102
1316506.556
± 314196.0436
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for IohexolSecondary· 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.
Group
Value
95% CI
Normal-CKD Stage 2/QuantumLeap
33329159.548
± 7909842.8639
CKD Stage 3-4/QuantumLeap
58097567.569
± 15177720.419
Normal-CKD Stage 2/Radiance
36677146.278
± 10789963.956
CKD Stage 3-5/Radiance
70005450.758
± 30243153.821
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102Secondary· 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.
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)
1518516.431
± 106177.2201
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102
1340051.2
± 332392.6494
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for IohexolSecondary· 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.
Group
Value
95% CI
Normal-CKD Stage 2/QuantumLeap
34688858.452
± 9029243.5529
CKD Stage 3-4/QuantumLeap
81061044.851
± 37977572.641
Normal-CKD Stage 2/Radiance
38032869.839
± 11788838.136
CKD Stage 3-5/Radiance
90107803.206
± 61220389.979
Total Plasma Clearance of MB-102Secondary· 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∞.
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)
84.29
± 5.0376
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102
97.741
± 23.5163
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07273838 — Sodium-Glucose Cotransporter-2 Inhibitor for Patients With Acute Cardiorenal Syndrome
· Phase 2
· recruiting
NCT07262320 — Epidemiology and Processes of Care for Renal Replacement Therapy in Acute Kidney Injury in Latin America
· recruiting
NCT07351149 — Postoperative Acute Kidney Injury in Children Undergoing Major Non-cardiac Surgery
· recruiting
NCT07215702 — A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kid
· Phase 2
· recruiting
NCT06654193 — Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute Kidney Injury
· Phase 1, PHASE2
· recruiting
Other MediBeacon trials
Trials by the same sponsor.
NCT05777174 — Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable
· Phase 3
· completed
NCT05425719 — Pharmacokinetics and Safety of MB-102 (Relmapirazin) and the MediBeacon Transdermal GFR Measurement System in Evaluation
· Phase 3
· completed
NCT03962998 — Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability
· EARLY_PHASE1
· completed
NCT03810833 — Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System
· NA
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MediBeacon
Last refreshed: 26 October 2023
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