Table 2.
Primary and exploratory clinical trial outcomes.
Coefficient of variation at study time points 1 (BD phase), 4 (end of HD phase) and 5 (WO phase). A percent reduction in CV between time points 1 and 4 of 0.25 or greater meets the endpoint.
| Metabolite | Time point | Mean | SD | CV | *CV % | *p value |
|---|---|---|---|---|---|---|
| indoxyl sulfate | 1 | 23.8 | 11.9 | 0.49901 | −1.7% | 0.48 |
| indoxyl sulfate | 4 | 21.0 | 10.1 | 0.48164 | ||
| indoxyl sulfate | 5 | 28.5 | 15.4 | 0.54070 | ||
| p-cresol sulfate | 1 | 21.9 | 15.8 | 0.71993 | 11.2 % | 0.59 |
| p-cresol sulfate | 4 | 25.8 | 21.5 | 0.83168 | ||
| p-cresol sulfate | 5 | 29.6 | 20.2 | 0.68478 | ||
| phenylacetylglutamine | 1 | 84.0 | 55.0 | 0.65436 | −0.05 | 0.78 |
| phenylacetylglutamine | 4 | 91.7 | 59.9 | 0.65383 | ||
| phenylacetylglutamine | 5 | 107.0 | 74.7 | 0.69846 | ||
| Hippuric acid | 1 | 261.3 | 194.0 | 0.74231 | −27.9 % | p < .001 |
| Hippuric acid | 4 | 95.0 | 44.0 | 0.46304 | ||
| Hippuric acid | 5 | 277.4 | 212.6 | 0.76654 |
*
Time point 1 vs time point 4