Table 4.

Primary and secondary efficacy outcomes: Reduction ratios (%) of middle molecules at 4 wk and 24 wk

Parameter^a	Dialyzer	Wk 4, n	Mean (SD)	Median	Minimum, Maximum	P Value	Wk 24, n	Mean (SD)	Median	Minimum, Maximum	P Value
Primary efficacy outcome
Reduction ratio of free λ light chains^b (45 kD)	Theranova 400	80	39.3 (14.5)	42.4	−46.2, 71.1	<0.001	63	33.3 (11.0)	32.8	8.1, 54.1	<0.001
Reduction ratio of free λ light chains^b (45 kD)	Control	75	19.9 (11.4)	18.9	−4.5, 41.6	<0.001	65	17.2 (12.9)	15.9	−10.7, 74.2	<0.001
Secondary efficacy outcomes
Reduction ratio of complement factor D (24 kD)	Theranova 400	83	43.0 (23.9)	48.0	−58.1, 78.5	<0.001	62	45.0 (10.4)	46.0	11.0, 68.0	<0.001
Reduction ratio of complement factor D (24 kD)	Control	76	20.9 (23.7)	22.5	−110.9, 77.8	<0.001	65	23.6 (12.1)	23.9	−47.0, 45.5	<0.001
Reduction ratio of free κ light chains (23 kD)	Theranova 400	80	68.8 (17.3)	72.1	−57.9, 94.6	<0.001	63	63.8 (11.8)	65.8	27.8, 87.4	<0.001
Reduction ratio of free κ light chains (23 kD)	Control	75	54.8 (14.5)	56.0	−29.1, 77.6	<0.001	65	50.0 (13.2)	49.4	2.3, 74.1	<0.001
Reduction ratio of IL-6 (25 kD)	Theranova 400	80	5.5 (45.9)	19.6	−155.4, 66.1	0.09	63	11.0 (37.8)	20.8	−128.5, 66.2	0.05
Reduction ratio of IL-6 (25 kD)	Control	78	−9.2 (60.6)	3.9	−341.2, 55.6	0.09	65	−2.6 (39.4)	7.8	−162.2, 46.2	0.05
Reduction ratio of TNFα (17 kD)	Theranova 400	80	52.5 (9.4)	54.3	16.3, 72.4	<0.001	63	50.7 (9.3)	52.2	23.8, 68.5	<0.001
Reduction ratio of TNFα (17 kD)	Control	78	44.1 (9.3)	45.3	11.0, 58.1	<0.001	65	41.5 (10.2)	41.9	−0.9, 57.9	<0.001
Reduction ratio of β2-microglobulin (11.8 kD)	Theranova 400	78	75.7 (8.2)	77.2	46.6, 98.9	<0.001	63	73.6 (10.4)	75.9	30.3, 96.7	<0.001
Reduction ratio of β2-microglobulin (11.8 kD)	Control	76	64.9 (8.9)	65.6	24.1, 83.2	<0.001	65	65.4 (9.4)	65.9	36.8, 90.0	<0.001

↵a Baseline, predialysis, and postdialysis concentrations can be found in Supplemental Table 13.
↵b The reduction ratio of free λ light chains at 4 weeks of treatment was a secondary efficacy outcome.