Blood was drawn for standard evaluation of kidney function.
After an overnight fast, at breakfast time, and before the sensor insertion, venous blood samples were drawn for nitrotyrosine evaluation at visits 1 and 3. Serum concentrations of IL-6 and IL-18 were determined in duplicate using a highly sensitive, quantitative sandwich enzyme assay (Quantikine HS PharmPak, R&D Systems).
In addition to performing the POCT (which measures blood erythrocyte self-TG2-autoantibody complexes) on site, blood was drawn for later evaluations of serum IgA-class endomysial antibodies (EMA).
Patients responded to the brief fatigue inventory (BFI) and Chalder fatigue questionnaires and had their blood drawn for both plasma evaluation and evaluation of the peripheral mononuclear cell fraction (PMNCF) mRNA expression of various biomarkers.
Blood draws for safety evaluation and humoral responses were taken at scheduled time points during the study (Figure 2).
Blood draws for safety evaluation and measurement of humoral responses were taken at scheduled time points during the study (see Table 1).
Blood draws for immunogenicity evaluation were performed at baseline, 1 month (results described elsewhere) [ 7], 6 months, and 1 year after vaccination.
Then, SCs were drawn for the performance based evaluation using the Bayesian statistical method.
Respectively, 30 ml per assessment will be drawn for the pre-treatment evaluation, at week 5 of the primary treatment phase, 1 week after the primary treatment phase, at 12 different time points during the maintenance treatment phase (weeks 14, 26, 38, 50, 62, 74, 86, 98, 110, 122, 134 and 146) and at the end of treatment evaluation.
