The purpose of this study is to assess the safety and effectiveness of roxadustat dosing regimens among hemodialysis participants converted from erythropoiesis stimulating agent (ESA) therapy or who are ESA-naïve.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
283
Roxadustat will be administered per dose and schedule specified in the arm description.
Alaska
Anchorage, Alaska, 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. 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. 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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Investigator Site
Pine Bluff, Arkansas, United States
Investigational Site
Cerritos, California, United States
Investigational Site
Victorville, California, United States
Investigational Site
Denver, Colorado, United States
Investigational Site
Hartford, Connecticut, United States
Investigational Site
Coral Gables, Florida, United States
Investigational Site
Hollywood, Florida, United States
Investigator Site
Dalton, Georgia, United States
Investigational Site
Statesboro, Georgia, United States
...and 16 more locations