Clinical Trial Details
| Trial ID: | L0927 |
| Source ID: | NCT04621331 |
| Associated Drug: | Roxadustat |
| Title: | Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD |
| Acronym: | |
| Status: | WITHDRAWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Anemia Associated With Chronic Kidney Disease |
| Interventions: | DRUG: Roxadustat |
| Outcome Measures: | Primary: Proportion of patients with mean Hb ≥ 11.0 g/dL, Averaged over weeks 16-24 | Secondary: Mean change in Hb, Baseline to averaged over weeks 16-24|Time to first Hb response (this only applies to NDD patients), From baseline without rescue therapy |
| Sponsor/Collaborators: | Sponsor: FibroGen | Collaborators: AstraZeneca |
| Gender: | ALL |
| Age: | CHILD, ADULT |
| Phases: | PHASE3 |
| Enrollment: | 0 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2022-05-23 |
| Completion Date: | 2022-05-23 |
| Results First Posted: | |
| Last Update Posted: | 2022-07-05 |
| Locations: | Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, 60611, United States|University of Nebraska Medical Center, Omaha, Nebraska, 68198, United States|Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH), New York, New York, 10029, United States|Investigative site, San Antonio, Texas, 78215, United States |
| URL: | https://clinicaltrials.gov/show/NCT04621331 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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