Table 3.
HD circuit clotting results for patients included in the randomized IONIS-FXIRx and placebo groups (per-protocol and ITT populations)
| Overall air trap and dialyzer events with a clotting category ≥3 | Pooled placebo (n = 10) | IONIS-FXIRX 200 mg (n = 12) |
IONIS-FXIRX 300 mg (n = 12) |
|---|---|---|---|
| Number of category ≥3 events/total events, (%)a | |||
| Before week 6 (baseline) | |||
| Per-protocol population | 43/70 (61.4%) | 60/83 (72.3%) | 38/85 (44.7%) |
| Intent-to-treat population | 47/91 (51.6%) | 73/99 (73.7%) | 41/103 (39.8%) |
| Between week 6 and week 13 | |||
| Per-protocol population | 49/79 (62.0%) | 38/95 (40.0%) | 18/90 (20.0%) |
| Intent-to-treat population | 52/102 (51.0%) | 41/98 (41.8%) | 19/101 (18.8%) |
| Subject difference in percent of clotting scores ≥3 between weeks 6–13 and before week 6 | |||
| Per-protocol population | |||
| Mean difference (SEM) | −1.6% (5.6) | −32.5% (7.9) | −25.9% (8.1) |
| P value vs. placebob | 0.0074 | 0.029 | |
| P value vs. 200 mg groupb | 0.54 | ||
| Intent-to-treat population | |||
| Mean difference (SEM) | −0.2% (7.7) | −28.9% (8.1) | −19.0% (7.5) |
| P value vs. placebob | 0.013 | 0.093 | |
| P value vs. 200 mg groupb | 0.33 | ||
HD, hemodialysis; ITT, intent-to-treat.
The number of category ≥3 events from the total events from all circuit clotting categories. Category 3 events included clot formation on venous chamber and blood stripes affecting ≥5% of the fibers found at the surface of the dialyzer. Category 4 events included coagulated system (treatment cannot continue without new setup) and coagulated filter.
P values are based on 1-way analysis of variance of the differences, using treatment group as the independent model variable. The comparison is between the change in the percent of category ≥3 events between the 2 periods. For each patient, the percent of scores ≥3 before week 6 was subtracted from the percent of scores ≥3 for weeks 6 to 13.