780: Clinical Validation of a Transdermal GFR Measurement System in Chinese Individuals

Introduction: A prior global study confirmed the safety and efficacy of MB-102 and the MediBeacon® Transdermal Glomerular Filtration Rate Measurement System (TGFR) in American and Chinese populations. Given variability in Fitzpatrick skin types (FSS) across ethnicities, further analysis was warranted to assess the performance of MB-102 and TGFR specifically in Chinese individuals. Methods: This post hoc analysis of trial (NCT05425719) enrolled Chinese subjects with varying renal function, stratified by baseline estimated GFR (eGFR) into Cohort 1 (≥70 mL/min/1.73m2) and Cohort 2 (< 70 mL/min/1.73m2). Participants received a single intravenous dose of 130 mg MB-102. Plasma GFR (nGFR) was derived via systemic clearance using a two-compartment pharmacokinetic (PK) model. Concurrently, continuous transdermal GFR (tGFR) was recorded using the TGFR system. The primary endpoint was P30, the proportion of tGFR values within ±30% of body surface area-indexed nGFR (nGFRBSA). Results: The safety set (SS) and modified intent-to-measure set (mITMS) included 54 and 49 participants, respectively; 96.3% in the SS were FSS I-III. In the mITMS, median nGFRBSA and tGFR were 73.081 (range: 22.73-118.29) and 74.056 (range: 27.80-140.00) mL/min/1.73m2. The P30 was 98.0% (95% CI: 89.1-99.9), exceeding the predefined 85% threshold and consistent with global findings. Bland-Altman analysis showed a mean bias (tGFR - nGFRBSA) of 0.07 mL/min/1.73m2 with 95% limits of agreement (LoA) from -18.78 to 18.64. In Cohorts 1 and 2, mean differences were -2.06 (LoA: -26.42 to 22.30) and 2.01 (LoA: -6.78 to 10.80), respectively. Four subjects fell outside the ±1.96 standard deviation range. Regression analysis yielded a slope of 0.89 (95% CI: 0.80-0.98) and intercept of 7.70. The intraclass correlation coefficient between tGFR and nGFRBSA was 0.945. Treatment-emergent adverse events occurred in 3.7% of subjects, with no serious, device-related, or drug-related events reported. Conclusions: This analysis confirms high concordance between transdermal and plasma MB-102 clearance in Chinese subjects with diverse renal function. TGFR plus MB-102 offers a safe, accurate, non-invasive option for real-time GFR monitoring, supporting its clinical application in this population.