Time to Rethink the Current Paradigm for Assessing Kidney Function in Drug Development and Beyond.

Given that the value of eGFR ranges from 15 mL/min/1.73 m 2 in subjects with severe kidney impairment to 89 mL/min/1.73 m 2 in subjects with mild kidney impairment, a variance of 30% is quite significant and can lead to mis‐categorization of a significant number of subjects between mild vs. moderate or moderate vs. severe kidney impairment and specifically for values that are close to borderlines of a category.

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