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Clinical Trial Details

Trial ID: L0905
Source ID: NCT03140722
Associated Drug: Vadadustat
Title: Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03140722/results
Conditions: Anemia|Dialysis-Dependent Chronic Kidney Disease
Interventions: DRUG: vadadustat|DRUG: epoetin alfa
Outcome Measures: Primary: Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period, Baseline; up to 20 weeks | Secondary: Number of Participants Demonstrating Incremental Increases in Hb From Baseline Over Time During the Treatment Period, Baseline; up to 20 weeks|Number of Participants With Hb Values Within the Target Range of 10.0-11.0 Grams Per Deciliter (g/dL) During the Treatment Period, Baseline; up to 20 weeks|Number of Participants Receiving Epoetin Alfa Rescue, up to 20 weeks|Number of Participants Receiving Red Blood Cell Transfusion, up to 20 weeks|Number of Participants With Specified Levels of Various Biomarkers, Including C-reactive Protein, Hepcidin, and Vascular Endothelial Growth Factor, up to 20 weeks|Mean Weekly Dose of Intravenous Elemental Iron Administered, up to 20 weeks|Number of Participants Maintaining Iron Sufficiency (Defined as Ferritin ≥100 Nanograms Per Milliliter and Transferrin Saturation ≥20%), up to 20 weeks|Number of Participants Utilizing Resources, up to 20 weeks|Number of Participants With Treatment-emergent Adverse Events, Treatment-emergent adverse events were collected in all participants enrolled in the study., up to 24 weeks
Sponsor/Collaborators: Sponsor: Akebia Therapeutics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 2
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-05-02
Completion Date: 2018-03-21
Results First Posted: 2021-02-21
Last Update Posted: 2021-02-21
Locations: Research Site, Bakersfield, California, 93309, United States|Research Site, Elk Grove, California, 95758, United States|Research Site, Encino, California, 91316, United States|Research Site, Escondido, California, 92025, United States|Research Site, Lynwood, California, 90262, United States|Research Site, San Diego, California, 92115, United States|Research Site, San Luis Obispo, California, 93401, United States|Research Site, Waterbury, Connecticut, 06708, United States|Research Site, Miami, Florida, 33183, United States|Research Site, Orlando, Florida, 32804, United States|Research Site, Statesboro, Georgia, 30458, United States|Research Site, Detroit, Michigan, 48224, United States|Research Site, Bronx, New York, 10473, United States|Research Site, Philadelphia, Pennsylvania, 19106, United States|Research Site, El Paso, Texas, 79915, United States|Research Site, Houston, Texas, 77070, United States|Research Site, Newport News, Virginia, 23605, United States|Research Site, Norfolk, Virginia, 23502, United States
URL: https://clinicaltrials.gov/show/NCT03140722

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress