Table 4.

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

ParameteraDialyzerWk 4, nMean (SD)MedianMinimum, MaximumP ValueWk 24, nMean (SD)MedianMinimum, MaximumP Value
Primary efficacy outcome
 Reduction ratio of free λ light chainsb (45 kD)Theranova 4008039.3 (14.5)42.4−46.2, 71.1<0.0016333.3 (11.0)32.88.1, 54.1<0.001
Control7519.9 (11.4)18.9−4.5, 41.66517.2 (12.9)15.9−10.7, 74.2
Secondary efficacy outcomes
 Reduction ratio of complement factor D (24 kD)Theranova 4008343.0 (23.9)48.0−58.1, 78.5<0.0016245.0 (10.4)46.011.0, 68.0<0.001
Control7620.9 (23.7)22.5−110.9, 77.86523.6 (12.1)23.9−47.0, 45.5
 Reduction ratio of free κ light chains (23 kD)Theranova 4008068.8 (17.3)72.1−57.9, 94.6<0.0016363.8 (11.8)65.827.8, 87.4<0.001
Control7554.8 (14.5)56.0−29.1, 77.66550.0 (13.2)49.42.3, 74.1
 Reduction ratio of IL-6 (25 kD)Theranova 400805.5 (45.9)19.6−155.4, 66.10.096311.0 (37.8)20.8−128.5, 66.20.05
Control78−9.2 (60.6)3.9−341.2, 55.665−2.6 (39.4)7.8−162.2, 46.2
 Reduction ratio of TNFα (17 kD)Theranova 4008052.5 (9.4)54.316.3, 72.4<0.0016350.7 (9.3)52.223.8, 68.5<0.001
Control7844.1 (9.3)45.311.0, 58.16541.5 (10.2)41.9−0.9, 57.9
 Reduction ratio of β2-microglobulin (11.8 kD)Theranova 4007875.7 (8.2)77.246.6, 98.9<0.0016373.6 (10.4)75.930.3, 96.7<0.001
Control7664.9 (8.9)65.624.1, 83.26565.4 (9.4)65.936.8, 90.0
  • 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.