Statistical analysis was carried out using SPSS statistical package version 28.0, May 2021, IBM corporation software group, USA. A chi-square test was applied to compare categorical clinical variables between groups. The Shapiro–Wilk test was applied to the measured parameters before running parametric statistical analysis. Normality test results reveal the normal distribution of our data with a P-value greater than 0.05. Analysis of baseline characteristics and biomarkers was done using unpaired student t-test for parametric data. Comparing the two groups mean values and the percent change in variables were done using a student t-test with statistical significance being set at P < 0.05. Correlation analysis was done using Pearson correlation. Correlation coefficients are interpreted as weak (< 0.4); moderate (0.4–< 0.7), or strong relationship (> 0.9). [24 (link)]. A linear regression test was also conducted to evaluate the association between the measured biomarkers and UACR.
Considering that the primary objective of this trial was to compare UACR between the niclosamide arm and control arm, we calculated the minimum number of patients needed to detect the 20% change in UACR. The lower limit of 20% UACR reduction was chosen as a cut-off point representing clinical relevance which is not likely to be subjected to variance error. The assumed mean of the control group was 300 mg/g, and the expected mean difference between the control and treatment groups was 60 mg/g. Assuming 80% power, a two-sided type I error rate of 0.05, an allocation ratio (r = 1), and a standard deviation equal to 75 mg/g. After applying a 15% dropout rate, 29 participants were needed in each arm of the trial. Therefore, it was planned to enroll 30 patients per arm for 1:1 randomization.
Considering that the primary objective of this trial was to compare UACR between the niclosamide arm and control arm, we calculated the minimum number of patients needed to detect the 20% change in UACR. The lower limit of 20% UACR reduction was chosen as a cut-off point representing clinical relevance which is not likely to be subjected to variance error. The assumed mean of the control group was 300 mg/g, and the expected mean difference between the control and treatment groups was 60 mg/g. Assuming 80% power, a two-sided type I error rate of 0.05, an allocation ratio (r = 1), and a standard deviation equal to 75 mg/g. After applying a 15% dropout rate, 29 participants were needed in each arm of the trial. Therefore, it was planned to enroll 30 patients per arm for 1:1 randomization.
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