Table 5. Change in hematology and other laboratory variables from baseline to end of treatment (safety analysis set).

Variable	Placebo (n=39)	Ipragliflozin (n=43)	P valuea
Renal function
BUN, mg/dL	1.1±3.97	2.9±4.56	0.072
Cr, mg/dL	0.034±0.095	0.026±0.115	0.725
BUN:Cr ratio	1.06±11.50	3.83±7.76	0.200
Hematology
RBC count, ×104/µL	–7.7±18.71	17.2±18.48	<0.001
Hemoglobin, g/dL	–0.26±0.75	0.42±0.58	<0.001
Hematocrit, %	–0.40±1.98	2.00±1.76	<0.001
Fluid and electrolyte balance
Na, mEq/L	–0.2±2.07	0.1±2.24	0.573
K, mEq/L	0.06±0.41	0.15±0.33	0.259
Cl, mEq/L	–1.1±2.96	–0.3±2.92	0.251
Ca, mg/dL	–0.25±0.30	–0.25±0.46	0.980
Mg, mg/dL	0.07±0.15	0.17±0.22	0.015
P, mg/dL	–0.07±0.47	0.19±0.45	0.013
Urine NAG/Cr ratio, U/g Cr	0.42±5.93	1.83±6.53	0.312
Urine albumin/Cr ratio, mg/g Cr	2.74±24.64	–10.93±58.92	0.182
Urine osmolality, mOsm/L	–41.9±223.54	58.5±219.58	0.043
Urine Na/Cr ratio, mEq/g Cr	22.9±93.67	33.6±100.77	0.623
Urine K/Cr ratio, mEq/g Cr	11.86±39.80	31.09±38.28	0.029
Urine Cl/Cr ratio, mEq/g Cr	10.1±108.21	24.3±108.57	0.555
Urine Ca/Cr ratio, mg/g Cr	11.04±73.00	29.34±93.79	0.331
Urine Mg/Cr ratio, mg/g Cr	3.15±35.65	16.60±32.50	0.078
Urine P/Cr ratio, mg/g Cr	55.66±291.31	277.89±315.43	0.001
Liver function
AST, U/L	–3.1±10.56	–3.9±7.89	0.704
ALT, U/L	–3.5±17.40	–8.7±17.75	0.192
Total bilirubin, mg/dL	0.00±0.22	0.00±0.18	0.962
Direct bilirubin, mg/dL	0.00±0.13	0.01±0.10	0.643
LDH, U/L	–5.4±28.36	–5.5±35.75	0.986
ALP, U/L	–4.2±29.01	–7.4±29.74	0.617
γ-GTP, U/L	–1.4±14.62	–8.1±18.40	0.073

Values are presented as mean±standard deviation.

BUN, blood urea nitrogen; Cr, creatinine; RBC, red blood cell; NAG, β-N-acetyl-D-glucosaminidase; AST, aspartate transaminase; ALT, alanine transaminase; LDH, lactate dehydrogenase; ALP, alkaline phosphatase; γ-GTP, γ-glutamyl transpeptidase.

^aTwo-sample t-test.