Clinical Trial Details
| Trial ID: | L0691 |
| Source ID: | NCT00368901 |
| Associated Drug: | Darbepoetin Alfa |
| Title: | STAAR-2 Clinical Study |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease|Chronic Renal Insufficiency|Kidney Disease|Pre-dialysis|Pre-ESRD |
| Interventions: | DRUG: Darbepoetin alfa |
| Outcome Measures: | Primary: Mean hemoglobin during the evaluation period, 52 weeks | Secondary: Change in hemoglobin throughout the study, 52 weeks|HRQoL scores of rHuEPO-naïve subjects measured at baseline, week 12, week 24, and end of study, 52 weeks|Health-related resource utilization, measured every 4 weeks, throughout the study, 52 weeks|Patient satisfaction scores of subjects previously on rHuEPO therapy, measured at baseline and week 12, 12 weeks|Iron requirement (dose, frequency, and route) of subjects during the study, 52 weeks |
| Sponsor/Collaborators: | Sponsor: Amgen |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 618 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2002-01 |
| Completion Date: | 2004-05 |
| Results First Posted: | |
| Last Update Posted: | 2010-03-05 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT00368901 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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