The baseline characteristics were compared between treatment groups for all patients with data at month?3, for patients with proteinuria at month?3 and for patients without proteinuria at month?3. An analysis of variance model with treatment as a factor was used to analyze the continuous variables. A chi-square test was used to compare the categorical variables. Similar analyses were done to compare the baseline between the group with proteinuria at month?3 and the group without proteinuria at month?3. The rates of proteinuria were summarized by treatment from month?3 to month 24. A Wilcoxon rank sum test was used to compare the urine protein/creatinine ratios between each pair of treatment groups at each visit. A Cox proportional hazard regression model was used to estimate the risk of proteinuria. AZD 5363
The model included proteinuria SB431542 clinical trial
as a time-dependent variable with independent variables of treatment group, EVR target levels of 3�C8?ng/mL (below, within and above target), diabetes and BMI. An analysis of covariance model was used to compare mean GFR (MDRD) at various time points between treatment groups and to compare mean GFR (MDRD) between patients with and without proteinuria at month?3. Chi-square tests were used to compare the rates of graft loss of patients with and without proteinuria at month?3. The rates of graft loss between treatment groups were also compared. A similar analysis was also done comparing the rates of graft loss for patients with different levels Vemurafenib cost
of proteinuria (300�C1500?mg/day?vs.?>1500?mg/day). Logistic regression modeling was also performed for the rates of graft loss. Odds ratios were calculated for treatment groups, and for proteinuria versus no proteinuria at month?3. Of 833 patients, 277, 279 and 277 patients were initially randomized to EVR 1.5, EVR 3.0 and MPA arms, respectively (Table?1). For the assessment of changes in median proteinuria status over time and for time-dependent multivariate model, all samples available for all time points were utilized. The rationale for utilizing these data in this manner (an ��on therapy�� analysis) was to quantify the relationship of proteinuria status by immunouppressive agent (EVR?vs. MPA) arm and to correlate proteinuria status to actual EVR trough level achieved (exposure). As shown in Figure?1, measured proteinuria was highest for the EVR 3.0 arm, followed by EVR 1.5 and MPA arms, with all differences between groups for all time periods achieving statistical significance (p < 0.05). The median levels of proteinuria did not increase over time but remained stable among all treatment arms in this ��on therapy�� analysis. When examining proteinuria as a categorical value, at 3?months a total of 58/240 (24%), 87/242(36%) and 47/244(19%) of the EVR 1.5, 3.