Clinical Trial Details
| Trial ID: | L1619 |
| Source ID: | NCT00146224 |
| Associated Drug: | Epoetin Alfa Rb |
| Title: | Efficacy of Epoetin Alfa Deep Tank in Treatment of Anemia in Patients With Chronic Kidney Disease Receiving Hemodialysis |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Nephrology |
| Interventions: | DRUG: Epoetin alfa RB|DRUG: Epoetin alfa DT |
| Outcome Measures: | Primary: Ratio of weekly dose at the evaluation period to the weekly dose at baseline, Entire Study|Change in Heloglobin level between the screening period and the evaluation period, Entire Study | Secondary: Change from baseline Hb at each measurement timepoint, Entire Study|Maintaining Hemoglobin within range at each measurement timepoint, Entire Study|Average Epoetin alfa dose over evaluation period, evaluation period (weeks 21 - 28)|Change from baseline dose at each measurement timepoint, entire study|Epoetin alfa seroreactivity, entire study|Subject incidence, nature and severity of adverse events, entire study|Hemoglobin variability, entire study|changes from baseline laboraotry and vital sign parameters, entire study |
| Sponsor/Collaborators: | Sponsor: Amgen |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 420 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2005-09 |
| Completion Date: | 2007-01 |
| Results First Posted: | |
| Last Update Posted: | 2010-02-26 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT00146224 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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