Ignite Creation Date:
2024-05-06 @ 5:46 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05425719
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2022-04-21
Brief 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
Sponsor:
MediBeacon
Organization:
MediBeacon
Study Overview
Official Title:
A Pivotal Open Label Multi-Center Safety and Pharmacokinetic Study of MB-102 Relmapirazin and the Use of the MediBeacon Transdermal GFR Measurement System in Normal and Renal Compromised Subjects for the Evaluation of Kidney Function
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial was to compare transdermal glomerular filtration rate tGFR to plasma-derived indexed to body surface area BSA GFR nGFR using MB-102 relmapirazin as the fluorescent compound Adults with kidney function ranging from normal to Stage 4 chronic kidney disease CKD and participants spanning the entire range of human skin colors as defined by the Fitzpatrick Skin Scale FSS were included in the study
The main questions that the study aimed to answer were
To establish that the MB-102 transdermal fluorescence measured GFR using the MediBeacon Transdermal GFR Measurement System is comparable to the measured MB-102 plasma GFR
To evaluate the safety and tolerability of a single dose of MB-102 in study participants
To evaluate the safety and effectiveness of the MediBeacon Transdermal GFR Measurement System TGFR for the non-invasive transdermal fluorescence detection of MB-102 in participants
Participants had a transdermal sensor placed on their upper chest and the TGFR collected background fluorescence Participants then received a single dose of MB-102 Blood samples were collected and fluorescent measurements were taken over a 12- to 24-hour period Following completion of the treatment period participants returned to the study center approximately 1 week later for a safety follow-up visit Researchers compared the results to see if the transdermal GFR measurements were comparable to the measured plasma GFR in those with and without normal kidney function and different skin coloration
The main questions that the study aimed to answer were
To establish that the MB-102 transdermal fluorescence measured GFR using the MediBeacon Transdermal GFR Measurement System is comparable to the measured MB-102 plasma GFR
To evaluate the safety and tolerability of a single dose of MB-102 in study participants
To evaluate the safety and effectiveness of the MediBeacon Transdermal GFR Measurement System TGFR for the non-invasive transdermal fluorescence detection of MB-102 in participants
Participants had a transdermal sensor placed on their upper chest and the TGFR collected background fluorescence Participants then received a single dose of MB-102 Blood samples were collected and fluorescent measurements were taken over a 12- to 24-hour period Following completion of the treatment period participants returned to the study center approximately 1 week later for a safety follow-up visit Researchers compared the results to see if the transdermal GFR measurements were comparable to the measured plasma GFR in those with and without normal kidney function and different skin coloration
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None