Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE-CONVERSION)

CompletadoFase 3ClinicalTrials.gov

ID: NCT02892149Tipo: INTERVENTIONALInicio: 1 de ago de 2016Fin estimado: 30 de mar de 2020

Traducción no disponible, mostrando original

Resumen

A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with dialysis-dependent chronic kidney disease (DD-CKD)

Descripción detallada

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 DD-CKD

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

≥18 years of age
Receiving chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease for at least 12 weeks prior to Screening
Currently maintained on erythropoiesis-stimulating agent therapy, with a dose received within 6 weeks prior to or during Screening
Mean Screening hemoglobin between 8.0 and 11.0 grams per deciliter (g/dL) (inclusive) in the US and between 9.0 and 12.0 g/dL (inclusive) outside of the US
Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening

Criterios de exclusión

Anemia due to a cause other than chronic kidney disease or participants with active bleeding or recent blood loss
Uncontrolled hypertension
Red blood cell transfusion within 8 weeks prior to randomization
Anticipated to recover adequate kidney function to no longer require dialysis
Severe heart failure at Screening (New York Heart Association Class IV)
Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure, or stroke within 12 weeks prior to or during Screening
Hypersensitivity to Vadadustat, Darbepoetin alfa, or any of their excipients

Intervenciones

drug

Vadadustat

Oral dose administered once daily for ≥36 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.

drug

Darbepoetin alfa

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.

Ubicaciones

Research Site

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Research Site

Junín, Buenos Aires, Argentina

Research Site

Pergamino, Buenos Aires, Argentina

Research Site

Sarandí, Buenos Aires, Argentina

Research Site

Corrientes, Argentina

Research Site

Córdoba, Argentina

Research Site

Córdoba, Argentina

Research Site

Salta, Argentina

Research Site

San Luis, Argentina

Patrocinadores

PrincipalAkebia Therapeutics

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