Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Depen… (NCT03054337) | Clinical Trial Compass
CompletedPhase 2
Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)
Japan51 participantsStarted 2016-10
Plain-language summary
This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese participants with anemia secondary to Non-dialysis Dependent Chronic Kidney Disease (NDD-CKD).
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female Japanese participants ≥20 years of age
* Diagnosis of chronic kidney disease (CKD) based on an estimated glomerular filtration rate ≤60 milliliters per minute per 1.73 meters squared (mL/min/1.73 m\^2)
* Hemoglobin (Hb) ≤10.5 grams per deciliter (g/dL)
* Not currently being treated with dialysis and not expected to start dialysis within 3 months of screening
Exclusion Criteria:
* Anemia due to a cause other than CKD or presence of active bleeding or recent blood loss
* Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
* Red blood cell transfusion within 4 weeks prior to or during screening
* Intravenous iron within 4 weeks prior to or during screening
* Any use of erythropoiesis-stimulating agents within 6 weeks prior to or during screening
What they're measuring
1
Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period