What question did this study set out to answer?

This research aims to evaluate the bioequivalence and efficacy of MB-102 in combination with transdermal GFR monitoring in individuals with varying renal function.

March 26, 2026

781: Bioequivalence and Efficacy Study of Mb-102 With Transdermal GFR Measurement in Chinese Subjects

Key Points

This research aims to evaluate the bioequivalence and efficacy of MB-102 in combination with transdermal GFR monitoring in individuals with varying renal function.
Conducted a randomized, crossover study comparing MB-102DMS and MB-102OMS in healthy volunteers.
Performed an open-label trial to assess efficacy and safety of MB-102DMS combined with TGFR monitoring.
Participants were divided into two cohorts based on baseline estimated GFR (eGFR).
Utilized a two-compartment pharmacokinetic model for plasma GFR calculations.
MB-102DMS demonstrated a geometric mean ratio of AUC₀-∞ of 100.5%, confirming bioequivalence with MB-102OMS.
In the efficacy trial, 97.8% of tGFR values were within ±30% of plasma GFR, surpassing the target threshold.
Efficacy results showed P30 values of 100.0% for Cohort 1 and 95.7% for Cohort 2.
No serious treatment-related adverse events occurred, indicating a favorable safety profile.

Abstract

Introduction: To address the clinical need for non-invasive, real-time glomerular filtration rate (GFR) assessment, this study evaluated the bioequivalence (BE), efficacy, and safety of MB-102 plus MediBeacon® Transdermal GFR Monitoring System (TGFR) in Chinese individuals with normal or impaired renal function. Methods: This study (NCT05943977) comprised two parts. Part I was a randomized, crossover BE study comparing domestic manufactured MB-102 (MB-102DMS) with oversea manufactured formulation (MB-102OMS) in healthy volunteers. Part II was an open-label trial evaluating the efficacy and safety of MB-102DMS with TGFR. Subjects were stratified by baseline estimated GFR (eGFR) into Cohort 1 (≥70 mL/min/1.73m2) and Cohort 2 (85%). P30 values were 100.0% (95% CI: 92.13-100.0) in Cohort 1 and 95.7% (95% CI: 85.16-99.47) in Cohort 2. Intraclass correlation coefficients between tGFR and nGFRBSA were 0.961 (mITMS), 0.750 (Cohort 1), and 0.959 (Cohort 2). Bland-Altman analysis showed mean differences of 1.15 (mITMS), 0.03 (Cohort 1), and 2.25 mL/min/1.73m2 (Cohort 2). PK analysis showed lower clearance, prolonged half-life, and higher AUC in Cohort 2 versus Cohort 1. Treatment-related adverse events (AEs) occurred in < 2% of subjects and were not attributed to MB-102 or TGFR. No serious AEs were reported. Conclusions: MB-102DMS demonstrated BE to MB-102OMS. The combination with TGFR provided a safe, non-invasive, and reliable approach for dynamic GFR monitoring.

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Cite This Study

Xu et al. (Sun,) studied this question.

synapsesocial.com/papers/69c4cd65fdc3bde448919aae https://doi.org/https://doi.org/10.1097/01.ccm.0001185120.87027.5d

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