Approximately 50% of participants will have GFR > 70 mL/min/1.73m^2, and approximately 50% of participants will have GFR < 70 mL/min/1.73m^2.~Approximately 50% of participants enrolled in the United States will have a FSS value of I-III, and 50% of participants will be FSS IV-VI. The FSS stratification will not apply to participants enrolled in China because the population demographic is unlikely to support the full FSS spectrum.
This is a multi-center, open-label, pivotal study comparing transdermal glomerular filtration rate (tGFR) to plasma-derived indexed GFR (nGFR) with MB-102 (relmapirazin) as the fluorophore. Participants will span the GFR range of values from normal to stage 4 chronic kidney disease (CKD) and span the entire range of human skin colors as defined by the Fitzpatrick Skin Scale (FSS). The safety and pharmacokinetics of MB-102 and the safety of the MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) will also be evaluated.