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Clinical Trial Details

Trial ID: L0203
Source ID: NCT05425719
Associated Drug: Mb-102
Title: Pharmacokinetics and Safety of MB-102 (Relmapirazin) and the MediBeacon Transdermal GFR Measurement System in Evaluation of Kidney Function in Normal and Renal Compromised Subjects
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT05425719/results
Conditions: Chronic Kidney Disease
Interventions: DRUG: MB-102|DEVICE: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
Outcome Measures: Primary: Proportion of Transdermal Derived Glomerular Filtration Rate (tGFR) Values Within 30% of the nGFR Plasma-derived Indexed Glomerular Filtration Rate (nGFR) Values, The performance measure of P30 is defined as the proportion of transdermal derived GFR values that are within 30% of the measured plasma-derived GFR. The comparison of transdermal derived glomerular filtration rate (tGFR) with respect to the plasma-derived indexed glomerular filtration rate (nGFR) was calculated with a double-sided 95% confidence interval (CI). The performance goal was 0.85, and success for the study was defined as a lower limit of the 95% CI greater than 0.85., Up to 24 hours following the study dose | Secondary: Number of Participants With Treatment-emergent Adverse Events Associated With MB-102 Administration, 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., From the time of dosing through the follow-up visit, up to 10 days|Number of Participants With Treatment-emergent Adverse Events Associated With the MediBeacon Transdermal GFR Measurement System Device, 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., From the time of dosing through the follow-up visit, up to 10 days
Sponsor/Collaborators: Sponsor: MediBeacon
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 249
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2022-06-14
Completion Date: 2023-02-15
Results First Posted: 2024-04-18
Last Update Posted: 2024-04-18
Locations: Velocity Clinical Research, Edgewater, Florida, 32132, United States|Research by Design, LLC, Chicago, Illinois, 60643, United States|Nucleus Network, Saint Paul, Minnesota, 55114, United States|Carolina Phase I Research, Raleigh, North Carolina, 27612, United States|Endeavor Clinical Trials, LLC, San Antonio, Texas, 78240, United States|West China Hospital of Sichuan University, Chengdu, Sichuan, 610093, China|Peking University First Hospital, Beijing, 100034, China|Affiliated Hospital of Xuzhou Medical University, Xuzhou, 2210029, China
URL: https://clinicaltrials.gov/show/NCT05425719