This trial will be conducted to demonstrate the efficacy and safety of vadadustat compared to darbepoetin alfa for the maintenance treatment of anemia in hemodialysis participants after conversion from current erythropoiesis-stimulating agent (ESA) therapy.
This study consists of three periods: 1. Screening Period 2. Conversion and Maintenance Treatment Period 3. Safety Follow-up Period Individual participants will participate in total trial duration of approximately 64 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
319
oral tablets
intravenous or subcutaneous solution
Change From Baseline in Hb to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26)
The Baseline Hb was defined as the average of the last 2 central laboratory Hb values taken on or prior to the first dose date. The average for the PEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 20 through 26, regardless of intercurrent events. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as PEP value minus the Baseline value.
Time frame: Baseline; Weeks 20 to 26
Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52)
The Baseline Hb was defined as the average of the last 2 central laboratory Hb values taken on or prior to the first dose date. The average for the SEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 46 through 52, regardless of intercurrent events. Analysis was conducted using an ANCOVA model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as SEP value minus the Baseline value.
Time frame: Baseline; Weeks 46 to 52
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Research Site
Chula Vista, California, United States
Research Site
Granada Hills, California, United States
Research Site
Los Angeles, California, United States
Research Site
Lynwood, California, United States
Research Site
Northridge, California, United States
Research Site
San Dimas, California, United States
Research Site
Whittier, California, United States
Research Site
Denver, Colorado, United States
Research Site
Middlebury, Connecticut, United States
Research Site
Coral Gables, Florida, United States
...and 49 more locations