Tenapanor in Chinese ESRD patients with hyperphosphatemia on haemodialysis: a randomised, phase 3 trial.

"CONFLICT OF INTEREST STATEMENT G.W. and W.Z. are employees of Fosun Pharma. Y.Z. is employee of Wanbang Biopharmaceuticals. All other authors have declared no conflicts of interest."

"FUNDING This study was funded by Wanbang Biopharmaceuticals, a member enterprise of Fosun Pharma."

"The primary efficacy endpoint was evaluated by estimating least squares (LS) mean changes in the serum phosphorous level from baseline and the corresponding 95% confidence intervals (CIs). Treatment differences in the primary and secondary efficacy variables were compared using an analysis of covariance (ANCOVA) model with study centre and serum phosphorous level at baseline as covariates and treatment group as the independent variable. Sensitivity analyses were performed for the primary efficacy endpoint using a mixed model for repeated measures with study centre, treatment group, visit and treatment–visit interaction as fixed factors, baseline as a covariate and patient as a random effect. Treatment adherence was calculated as each patient's actual cumulative dose/the planned cumulative dose × 100. Categorical data were summarized using frequencies and percentages and continuous data were summarized using mean (SD) or median (minimum–maximum). All analyses were performed using SAS version 9.4 (SAS Institute, Cary, NC, USA). The study was registered at https://www.chictr.org.cn/index.aspx (ChiCTR2300068249) and http://www.chinadrugtrials.org.cn/index.html (CTR20202588)."