Article Figures & Data
Figures
- Figure 1.
Patient disposition. Enrollment, randomization, and completion of the clinical trial, including reasons for not completing the 24-week per protocol trial intervention, showing similar completion between the Theranova 400 and Elisio-17H randomization strata. FLC, free light chain; HD, hemodialysis; PD, peritoneal dialysis.
- Figure 2.
Removal of middle molecules at 4 and 24 weeks. The reduction ratios of free λ light chains, complement factor D, free κ light chains, TNFα, and β2-microglobulin were significantly higher in the Theranova group compared with the Elisio-17H group (P<0.001 for all). For IL-6, the difference was not statistically significant.
Tables
Characteristic Value Theranova 400, n=86 Control, n=86 Total, n=172 Age, yr Mean (SD) 59 (14) 60 (12) 59 (13) Weight, kg Mean (SD) 90 (24) 95 (26) 92 (25) Height, cm Mean (SD) 170 (11) 170 (11) 170 (11) Predialysis weight at first treatment day, kg n 86 85 171 Mean (SD) 90 (24) 95 (27) 92 (26) Postdialysis weight at first treatment day, kg n 86 85 171 Mean (SD) 88 (24) 93 (26) 92 (25) Sex, n (%) Female 32 (37%) 35 (41%) 67 (39%) Male 54 (63%) 51 (59%) 105 (61%) Race, n (%) American Indian or Alaska Native 0 0 0 Asian 5 (6%) 2 (2%) 7 (4%) Black 33 (38%) 35 (41%) 68 (40%) Native Hawaiian or other Pacific Islander 3 (4%) 3 (4%) 6 (4%) White 40 (47%) 42 (49%) 82 (48%) Other 5 (6%) 4 (5%) 9 (5%) Primary kidney diagnoses (top 4), n (%) Diabetic kidney disease 34 (40%) 43 (50%) 77 (45%) Hypertensive nephropathy 36 (42%) 24 (28%) 60 (35%) Polycystic kidney disease 3 (4%) 5 (6%) 8 (5%) GN 5 (6%) 3 (4%) 8 (5%) Medical history Hypertension, n (%) 78 (91%) 75 (87%) 153 (89%) Diabetes mellitus type 2, n (%) 47 (55%) 55 (64%) 102 (59%) Years on dialysis n 79 74 153 Mean (SD) 5.4 (5) 4.7 (4) 5.1 (4) Type of current vascular access, n (%) Arteriovenous fistula 68 (79%) 74 (86%) 142 (83%) Arteriovenous graft 12 (14%) 12 (14%) 24 (14%) Dual lumen catheter 6 (7%) 0 6 (4%) Heparin type, n (%) Unfractionated heparin 68 (79%) 61 (71%) 129 (75%) Low-molecular-weight heparin 15 (17%) 15 (17%) 30 (17%) Missing 3 (4%) 10 (12%) 13 (8%) Parameter Dialyzer n Mean (SD) Median Minimum, Maximum Two-Sided 95% Confidence Intervala Predialysis serum albumin after 24 wk, g/dl Theranova 400 64 4.0 (0.3) 4.0 3.5, 4.7 −0.12 to 0.05 Control 65 4.1 (0.4) 4.0 3.2, 4.9 ↵a If the lower bound of the two-sided 95% confidence interval around the mean estimated treatment difference between Theranova 400 and the control is >−0.1765, then noninferiority can be claimed. If the lower bound of the two-sided 95% confidence interval is >0, then superiority may be concluded.
- 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 - Table 4.
Primary and secondary efficacy outcomes: Reduction ratios (%) of middle molecules at 4 wk and 24 wk
Parametera 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 chainsb (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 Control 75 19.9 (11.4) 18.9 −4.5, 41.6 65 17.2 (12.9) 15.9 −10.7, 74.2 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 Control 76 20.9 (23.7) 22.5 −110.9, 77.8 65 23.6 (12.1) 23.9 −47.0, 45.5 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 Control 75 54.8 (14.5) 56.0 −29.1, 77.6 65 50.0 (13.2) 49.4 2.3, 74.1 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 Control 78 −9.2 (60.6) 3.9 −341.2, 55.6 65 −2.6 (39.4) 7.8 −162.2, 46.2 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 Control 78 44.1 (9.3) 45.3 11.0, 58.1 65 41.5 (10.2) 41.9 −0.9, 57.9 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 Control 76 64.9 (8.9) 65.6 24.1, 83.2 65 65.4 (9.4) 65.9 36.8, 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.
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