Table 3.

Secondary safety outcomes: Baseline and change from baseline of predialysis serum albumin

Parameter	Time Point	Theranova 400					Control					P Value
		n	Mean (SD)	Median	Minimum, Maximum	95% Confidence Interval	n	Mean (SD)	Median	Minimum, Maximum	95% Confidence Interval
Predialysis serum albumin, g/dl	Baseline	86	4.0 (0.3)	4.0	3.4, 4.9	NA	86	4.0 (0.3)	4.0	3.3, 4.7	NA	NA
Change in predialysis serum albumin from baseline, g/dl	4 wk	80	−0.1 (0.2)	−0.1	−0.8, 0.6	−0.14 to −0.03	77	0.0 (0.2)	0.0	−0.7, 0.5	−0.04 to 0.05	0.03
	8 wk	78	−0.1 (0.3)	−0.1	−0.8, 0.5	−0.17 to −0.05	77	0.0 (0.2)	0.0	−0.6, 0.5	−0.05 to 0.05	0.004
	12 wk	77	−0.1 (0.3)	−0.1	−1.2, 0.6	−0.19 to −0.06	72	−0.0 (0.2)	0.0	−0.8, 0.5	−0.10 to 0.01	0.13
	16 wk	72	−0.1 (0.3)	−0.1	−1.3, 0.7	−0.21 to −0.05	71	−0.0 (0.3)	0.0	−1.6, 0.5	−0.10 to 0.05	0.11
	20 wk	66	−0.1 (0.3)	−0.1	−0.7, 0.5	−0.15 to −0.02	69	0.0 (0.3)	0.0	−0.9, 0.5	−0.05 to 0.08	0.07
	24 wk	64	0.0 (0.3)	0.0	−0.6, 0.4	−0.06 to 0.07	65	0.0 (0.3)	0.1	−0.6, 0.8	−0.02 to 0.11	0.61