Clinical Trial Details
| Trial ID: | L1366 |
| Source ID: | NCT04484857 |
| Associated Drug: | Roxadustat |
| Title: | Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants |
| Acronym: | ASPEN |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT04484857/results |
| Conditions: | Anemia Associated With End Stage Renal Disease |
| 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. 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. 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: | 283 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2020-07-22 |
| Completion Date: | 2021-09-17 |
| Results First Posted: | 2022-07-26 |
| Last Update Posted: | 2022-07-26 |
| Locations: | Alaska, Anchorage, Alaska, 99515, United States|Investigator Site, Pine Bluff, Arkansas, 71603, United States|Investigational Site, Cerritos, California, 90703, United States|Investigational Site, Victorville, California, 92394, United States|Investigational Site, Denver, Colorado, 80230, United States|Investigational Site, Hartford, Connecticut, 06112, United States|Investigational Site, Coral Gables, Florida, 33134, United States|Investigational Site, Hollywood, Florida, 33024, United States|Investigator Site, Dalton, Georgia, 30720, United States|Investigational Site, Statesboro, Georgia, 30458, United States|Investigational Site, Roseville, Michigan, 48066, United States|Investigational Site, Kansas City, Missouri, 64111, United States|Investigational Site, Las Vegas, Nevada, 89178, United States|Investigator Site, Gallup, New Mexico, 87301, United States|Investigational Site, Bronx, New York, 10461, United States|Investigational Site, Austin, Texas, 78229, United States|Investigator Site, Dallas, Texas, 75237, United States|Investigational Site, El Paso, Texas, 79924, United States|Investigational Site, Houston, Texas, 77004, United States|Investigator Site, San Antonio, Texas, 78202, United States|Investigator Site, San Antonio, Texas, 78211, United States|Investigator Site, San Antonio, Texas, 78221, United States|Investigational Site, San Antonio, Texas, 78229, United States|Investigational Site, San Antonio, Texas, 78251, United States|Investigator Sites, San Antonio, Texas, 78521, United States|Investigational Site, Norfolk, Virginia, 23502, United States |
| URL: | https://clinicaltrials.gov/show/NCT04484857 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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