Table 4.

Secondary endpoint analysis T cell composition and activation.

Cells [G/l]	Mean ± SD—high flux	Mean ± SD—MCO	LMM—estimate	LMM—P
Leukocytes	7.21 ± 1.9	6.9 ± 1.8	0.077	0.70
Lymphocytes	1.36 ± 0.5	1.3 ± 0.4	− 0.44	0.18
Ex vivo unstimulated cells
CD3+	1.5 ± 0.6	1.2 ± 0.7	0.10	0.14
CD3+CD4+CD69+	0.006 ± 0.003	0.005 ± 0.004	0.0009	0.012
CD3+CD4+PD-1+	0.07 ± 0.04	0.05 ± 0.03	0.009	0.025
CD3+CD4+CTLA4+	0.01 ± 0.007	0.01 ± 0.006	0.002	0.067
CD3+CD8+CD69+	0.005 ± 0.003	0.004 ± .003	0.0009	0.14
CD3+CD8+PD-1+	0.02 ± 0.02	0.005 ± 0.01	0.003	0.056
CD3+CD8+CTLA4+	0.008 ± 0.007	0.007 ± 0.005	0.001	0.054
Stimulated cells (LPS)
CD3+CD4+CD69+	0.005 ± 0.005	0.005 ± 0.004	0.0007	0.10
CD3+CD4+PD-1+	0.10 ± 0.07	0.08 ± .06	0.01	0.059
CD3+CD4+CTLA-4+	0.012 ± 0.006	0.013 ± .009	− 0.0002	0.79
Stimulated cells (PMA)
CD3+CD4+CD69+	0.8 ± 0.4	0.7 ± 0.4	0.07	0.064
CD3+CD4+PD-1+	0.3 ± 0.2	0.2 ± 0.1	0.03	0.028
CD3+CD4+CTLA-4+	0.013 ± 0.008	0.012 ± 0.006	0.002	0.057

The impact of treatment on ex vivo cell activation (cryopreserved cells prior to HD session start) was modeled in a linear mixed effects model, with subject ID (nested in sequence) as a random effect and treatment (MCO = 0), period and sequence as the main effects, no significant carry over effect (= sequence not significant) was seen for the reported variables. “Scaled identity” was selected as covariance-structure. Mean values for each treatment are reported at the end of each period (T2 and T4, for a total of 34 patients).