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Clinical Trial Details

Trial ID: L1343
Source ID: NCT04410198
Associated Drug: Roxadustat
Title: Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04410198/results
Conditions: Anemia Associated With End Stage Renal Disease (ESRD)
Interventions: DRUG: Roxadustat
Outcome Measures: Primary: Percentage of Participants With Mean Hb Value ≥10 g/dL, Percentage of participants with mean Hb value ≥10 g/dL, averaged from Week 16 through Week 24 has been reported. 95% confidence interval (CI) was calculated based on the normal approximation to the binomial distribution., Week 16 through Week 24|Mean Hb Change From Baseline to Average Hb From Weeks 16-24, Baseline Hb was defined as the mean of available central laboratory Hb values prior to first dose of study medication including the predose Hb value collected on Day 1. Missing data was imputed using Monte Carlo Markov Chain (MCMC) imputation model., Baseline, Weeks 16-24 |
Sponsor/Collaborators: Sponsor: FibroGen | Collaborators: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 203
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-05-26
Completion Date: 2021-10-11
Results First Posted: 2022-09-13
Last Update Posted: 2022-09-13
Locations: Investigational Site, Englewood, Colorado, 80110, United States|Investigational Site, Caldwell, Idaho, 83642, United States|Investigational Site, Baton Rouge, Louisiana, 70808, United States|Investigational Site, Kalamazoo, Michigan, 49009, United States|Investigational Site, Tupelo, Mississippi, 38801, United States|Investigational Site, Saint Ann, Missouri, 63074, United States|Investigational Site, Las Vegas, Nevada, 89106, United States|Investigational Site, Sugar Land, Texas, 77479, United States|Investigational Site, Saint George, Utah, 84790, United States
URL: https://clinicaltrials.gov/show/NCT04410198

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress