Clinical Trial Details
| Trial ID: | L1497 |
| Source ID: | NCT00527215 |
| Associated Drug: | Darbepoetin Alfa |
| Title: | Phase 2 Study of Darbepoetin Alfa Extended Dosing |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Pre-Dialysis |
| Interventions: | DRUG: darbepoetin alfa |
| Outcome Measures: | Primary: To assess the proportion of CRI subjects maintaining a target hemoglobin (Hb) range of 10.0 to 12.0 g/dL when administered subcutaneous (SC) darbepoetin alfa once every 4 weeks, Study weeks 21 - 29 | Secondary: To assess the safety, toleratbility, and pharmacokinetic (PK) profile of darbepoetin alfa when administered once every 4 weeks., Entire study |
| Sponsor/Collaborators: | Sponsor: Amgen |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 98 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2002-03 |
| Completion Date: | 2003-10 |
| Results First Posted: | |
| Last Update Posted: | 2009-05-22 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT00527215 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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