A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
This is a multicenter, randomized, open-label, active-controlled Phase 3 study of the efficacy and safety of Vadadustat versus Darbepoetin alfa for the maintenance treatment of anemia in participants with NDD-CKD
Oral dose administered once daily for ≥36 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
Subcutaneous or intravenous dose administered for ≥36 weeks. Initial dose based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
Bahía Blanca, Buenos Aires, Argentina
Junín, Buenos Aires, Argentina
Junín, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
Pergamino, Buenos Aires, Argentina
Ramos Mejía, Buenos Aires, Argentina
San Miguel, Buenos Aires, Argentina
San Nicolás de los Arroyos, Buenos Aires, Argentina
Sarandí, Buenos Aires, Argentina
Temperley, Buenos Aires, Argentina
Godoy Cruz, Mendoza Province, Argentina
Rosario, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
Ciudad Autonoma Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, Argentina
Corrientes, Argentina
Córdoba, Argentina
Córdoba, Argentina
Córdoba, Argentina
Córdoba, Argentina
Salta, Argentina
San Luis, Argentina