. 2021 Jun 25;14(5):1689–1704. doi: 10.1111/cts.13061

TABLE 2.

Classification of renal function based on FDA and EMA guidances ⁸ , ⁹

Stage	Description	Renal function ^a , ^b (ml/min)	GFR ^d (ml/min)
1	Control (normal renal function)7	≥90	≥90
2	Mild	60–89	60 to <90
3	Moderate	30–59	30 to <60
4	Severe	15–29	<30 (dialysis not required)
5	Kidney failure ^a , ^c ; ESRD ^d	<15 or dialysis patients on non‐dialysis days	<15 requiring dialysis

Abbreviations: EMA, European Medicines Agency; ESRD, end‐stage renal disease; FDA, US Food and Drug Administration; GFR, glomerular filtration rate.

^{^a}

As stated in the FDA guidance.

^{^b}

Estimate of GFR based on an estimation equation and expressed in ml/min. To convert ml/min/1.73 m² to ml/min multiply by the individual’s body surface area calculated using an appropriate formula and divide by 1.73.

^{^c}

This classification is strictly for the purposes of conducting a dedicated renal impairment study and should not be used for the purposes of classifying kidney disease.

^{^d}

As stated in the EMA guidance.