Clareo Health | Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)
Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Akebia Therapeutics
With
Otsuka Pharmaceutical Development & Commercialization, Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Receiving chronic, outpatient three times weekly (TIW) in-center hemodialysis for end-stage renal disease for at least 12 weeks prior to Screening
Hemodialysis adequacy as indicated by single-pool Kt/Vurea ≥ 1.2 using the most recent historical measurement within 8 weeks prior to or during Screening
Use of any approved erythropoiesis-stimulating agents (ESAs) for at least the 8 weeks prior to Screening Visit 2
Two hemoglobin (Hb) values, at least 4 days apart, measured by the central laboratory during Screening within the following prespecified ranges:
1. Hb values between 8.0 and 11.0 grams per deciliter (g/dL) (inclusive) in the United States;
2. Hb values between 9.0 and 12.0 g/dL (inclusive) in Europe
Serum ferritin ≥ 100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥ 20% during Screening
Folate and vitamin B12 measurements ≥ lower limit of normal during Screening
You may not be if
Anemia due to a cause other than chronic kidney disease (e.g., sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia)
Participants meeting cut-off of the following equivalent mean weekly doses calculated over 8 weeks prior to Screening Visit 2
3. Epoetin analogues \> 23000 International Units (IU)/week
Active bleeding or recent blood loss within 8 weeks prior to randomization
Red blood cell transfusion within 8 weeks prior to randomization
Current uncontrolled hypertension.
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 (HF) or New York Heart Association Class IV HF, or stroke within 12 weeks prior to or during Screening.
Known hypersensitivity to vadadustat, darbepoetin alfa, or any of their excipients
