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Clinical Trial Details

Trial ID: L1236
Source ID: NCT04707768
Associated Drug: Vadadustat
Title: Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04707768/results
Conditions: Anemia Associated With Chronic Kidney Disease (CKD)
Interventions: DRUG: Vadadustat|DRUG: Mircera®
Outcome Measures: Primary: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26), The Baseline Hb was defined as the average of last 2 central laboratory Hb measurements of samples taken at or prior to the first dose. The average for the PEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 20 through 26. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as PEP value minus the Baseline value., Baseline; Weeks 20 to 26 | Secondary: Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52), The Baseline Hb was defined as the average of the last 2 central laboratory Hb values taken on or prior to the first dose date. The average for the SEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 46 through 52. Analysis was conducted using an ANCOVA model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as SEP value minus the Baseline value., Baseline; Weeks 46 to 52
Sponsor/Collaborators: Sponsor: Akebia Therapeutics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 456
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-06-18
Completion Date: 2023-01-30
Results First Posted: 2025-01-15
Last Update Posted: 2025-01-15
Locations: Research Site, Huntsville, Alabama, 35805, United States|Research Site, Phoenix, Arizona, 85035, United States|Research Site, Pine Bluff, Arkansas, 71603, United States|Research Site, El Centro, California, 92243, United States|Research Site, Escondido, California, 92025, United States|Research Site, Fresno, California, 93720, United States|Research Site, Granada Hills, California, 91344, United States|Research Site, Porterville, California, 93257, United States|Research Site, San Diego, California, 92111, United States|Research Site, Arvada, Colorado, 80002, United States|Research Site, Denver, Colorado, 80210, United States|Research Site, Hockessin, Delaware, 19707, United States|Research Site, Bradenton, Florida, 34209, United States|Research Site, Coral Gables, Florida, 33134, United States|Research Site#1, Coral Springs, Florida, 33071, United States|Research Site#2, Coral Springs, Florida, 33071, United States|Research Site, Jacksonville, Florida, 32216, United States|Research Site, Athens, Georgia, 30606, United States|Research Site, Buford, Georgia, 30518, United States|Research Site, Dalton, Georgia, 30720, United States|Research Site, Macon, Georgia, 31201, United States|Research Site, Nampa, Idaho, 83687, United States|Research Site, Baton Rouge, Louisiana, 70884, United States|Research Site, Shreveport, Louisiana, 71101, United States|Research Site, Plymouth, Massachusetts, 02360, United States|Research Site, Springfield, Massachusetts, 01107, United States|Research Site, Kalamazoo, Michigan, 49007, United States|Research Site, Rochester Hills, Michigan, 48309, United States|Research Site, Saint Clair Shores, Michigan, 48081, United States|Research Site, Brookhaven, Mississippi, 39601, United States|Research Site, Columbus, Mississippi, 39705, United States|Research Site, Tupelo, Mississippi, 38801, United States|Research Site, North Platte, Nebraska, 69101, United States|Research Site, Las Vegas, Nevada, 89115, United States|Research Site, Reno, Nevada, 89511, United States|Research Site, Portsmouth, New Hampshire, 03801, United States|Research Site, Albuquerque, New Mexico, 87109, United States|Research Site, Gallup, New Mexico, 87301, United States|Research Site, Charlotte, North Carolina, 28204, United States|Research Site, Durham, North Carolina, 27704, United States|Research Site, Kinston, North Carolina, 28504, United States|Research Site, Raleigh, North Carolina, 27609, United States|Research Site, Columbus, Ohio, 43215, United States|Research Site, Kittanning, Pennsylvania, 16201, United States|Research Site, Knoxville, Tennessee, 37923, United States|Research Site, Arlington, Texas, 76015, United States|Research Site, Austin, Texas, 78758, United States|Research Site, Dallas, Texas, 75230, United States|Research Site, Dallas, Texas, 75231, United States|Research Site, Houston, Texas, 77074, United States|Research Site, Houston, Texas, 77099, United States|Research Site, Mansfield, Texas, 76063, United States|Research Site, Mission, Texas, 78572, United States|Research Site, San Antonio, Texas, 78211, United States|Research Site, San Antonio, Texas, 78251, United States|Research Site, Alexandria, Virginia, 22304, United States|Research Site, Salem, Virginia, 24153, United States|Research Site, Woodbridge, Virginia, 22192, United States
URL: https://clinicaltrials.gov/show/NCT04707768

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress