This trial is an investigator-initiated, multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the safety of vadadustat administered three times per week for the treatment of anemia in in-center hemodialysis patients with End Stage Kidney Disease (ESKD). This study will obtain long-term safety data in a large sample of subjects receiving in-center hemodialysis to support adoption of three times per week vadadustat dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,200
A synthetic, orally bioavailable, small molecule being developed as an inhibitor of hypoxia-inducible factor prolyl-hydroxylases for the treatment of anemia associated with chronic kidney disease. Intervention to be administered to maintain hemoglobin within a target range of 10-11 g/dL.
Standard of care erythropoiesis stimulating agent will be administered to maintain hemoglobin within a target range of 10-11 g/dL.
USRC Kidney Research
Lone Tree, Colorado, United States
Nephrology and Hypertension Specialists, PC
Dalton, Georgia, United States
US Renal Care - Gallup
Gallup, New Mexico, United States
Dallas Renal Group
Dallas, Texas, United States
Combination of the hierarchical endpoints of all-cause mortality and all-cause hospitalization.
The hierarchical endpoints of all-cause mortality and all cause hospitalization will be analyzed by the win odds method with ranking all cause mortality more important than all cause hospitalization.
Time frame: 18 months
All-cause hospitalization
All-cause hospitalization
Time frame: 18 months
All-cause mortality
All-cause mortality
Time frame: 18 months
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US Renal Care - Live Oak
Live Oak, Texas, United States