The purpose of this study is to assess the safety and effectiveness of Roxadustat dosing regimens among chronic dialysis participants converted from ESA therapy or who are ESA-naïve.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
203
Roxadustat will be administered per dose and schedule specified in the arm description.
Investigational Site
Englewood, Colorado, United States
Investigational Site
Caldwell, Idaho, United States
Investigational Site
Baton Rouge, Louisiana, United States
Investigational Site
Kalamazoo, Michigan, United States
Percentage of Participants With Mean Hb Value ≥10 g/dL
Percentage of participants with mean Hb value ≥10 g/dL, averaged from Week 16 through Week 24 has been reported. 95% confidence interval (CI) was calculated based on the normal approximation to the binomial distribution.
Time frame: Week 16 through Week 24
Mean Hb Change From Baseline to Average Hb From Weeks 16-24
Baseline Hb was defined as the mean of available central laboratory Hb values prior to first dose of study medication including the predose Hb value collected on Day 1. Missing data was imputed using Monte Carlo Markov Chain (MCMC) imputation model.
Time frame: Baseline, Weeks 16-24
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Investigational Site
Tupelo, Mississippi, United States
Investigational Site
Saint Ann, Missouri, United States
Investigational Site
Las Vegas, Nevada, United States
Investigational Site
Sugar Land, Texas, United States
Investigational Site
St. George, Utah, United States