Clinical Trial Details
| Trial ID: | L0791 |
| Source ID: | NCT04523727 |
| Associated Drug: | Ferric Citrate |
| Title: | Study to Evaluate the Safety and Tolerability of Ferric Citrate in Children With Hyperphosphatemia Related to Chronic Kidney Disease |
| Acronym: | |
| Status: | RECRUITING |
| Study Results: | NO |
| Results: | |
| Conditions: | Hyperphosphatemia Related to Chronic Kidney Disease |
| Interventions: | DRUG: ferric citrate |
| Outcome Measures: | Primary: Number of participants with serious and non-serious treatment-emergent adverse events (TEAEs) including gastrointestinal (GI) AEs of special interest, up to Week 40|Number of participants with clinically significant laboratory abnormalities or changes in laboratory results, up to Week 40|Number of participants with TEAEs leading to the discontinuation of ferric citrate, up to Week 40 | Secondary: Change from baseline in serum phosphorus to Week 12/early termination (ET), Baseline; up to Week 12 |
| Sponsor/Collaborators: | Sponsor: Keryx Biopharmaceuticals |
| Gender: | ALL |
| Age: | CHILD |
| Phases: | PHASE3 |
| Enrollment: | 45 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2022-06-16 |
| Completion Date: | 2026-10 |
| Results First Posted: | |
| Last Update Posted: | 2025-04-16 |
| Locations: | University of Alabama at Birmingham (UAB) - Children's of Alabama, Birmingham, Alabama, 35233, United States|Phoenix Childrens Hospital, Phoenix, Arizona, 85016, United States|University of California, San Francisco (UCSF) - Department of Nephrology, San Francisco, California, 94158, United States|Stanford University Medical Center, Stanford, California, 94305, United States|Children's Hospital Colorado, Aurora, Colorado, 80045, United States|University of South Florida, Tampa, Florida, 33606, United States|Johns Hopkins Hospital, Baltimore, Maryland, 21287, United States|Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan, 49503, United States|University of Minnesota, Minneapolis, Minnesota, 55455, United States|Children's Mercy Hospital - Kansas City, Kansas City, Missouri, 64108, United States|University of New Mexico, Albuquerque, New Mexico, 87110, United States|Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 45229, United States|University of Utah, Salt Lake City, Utah, 84113, United States|Seattle Children's Hospital, Seattle, Washington, 98105, United States |
| URL: | https://clinicaltrials.gov/show/NCT04523727 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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