Table 2.

Primary safety outcome: Predialysis serum albumin assessment after 24 weeks

ParameterDialyzernMean (SD)MedianMinimum, MaximumTwo-Sided 95% Confidence Intervala
Predialysis serum albumin after 24 wk, g/dlTheranova 400644.0 (0.3)4.03.5, 4.7−0.12 to 0.05
Control654.1 (0.4)4.03.2, 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.