Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05425719
Study type Interventional
Source MediBeacon
Contact
Status Completed
Phase Phase 3
Start date June 14, 2022
Completion date February 15, 2023

See also
  Status Clinical Trial Phase
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Terminated NCT04043026 - The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
Completed NCT05318014 - Low-protein Formula Supplements in Chronic Kidney Disease N/A
Active, not recruiting NCT06071065 - Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients N/A
Completed NCT02878317 - Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
Not yet recruiting NCT06039254 - Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function Phase 1
Recruiting NCT03160326 - The QUALITY Vets Project: Muscle Quality and Kidney Disease
Withdrawn NCT02885545 - The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial Phase 4
Completed NCT02756520 - Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
Completed NCT02836574 - A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease Phase 2
Completed NCT02896309 - The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity N/A
Completed NCT02888171 - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency N/A
Completed NCT02875886 - DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease Phase 4
Active, not recruiting NCT02483039 - Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization N/A
Completed NCT02369549 - Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease Phase 3
Terminated NCT02543177 - Optimised Procedure in Patients With NSTEMI and CKD N/A
Completed NCT02992548 - Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease Phase 4
Recruiting NCT02205944 - Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes N/A
Active, not recruiting NCT02231138 - Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease Phase 4