Clinical Trial Details
| Trial ID: | L1651 |
| Source ID: | NCT00422513 |
| Associated Drug: | Methoxy Polyethylene Glycol-Epoetin Beta |
| Title: | A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease. |
| Acronym: | |
| Status: | TERMINATED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00422513/results |
| Conditions: | Anemia |
| Interventions: | DRUG: methoxy polyethylene glycol-epoetin beta|DRUG: Epoetin alfa |
| Outcome Measures: | Primary: Time Spent on Anemia Treatment Over Evaluation Period, Efficacy and pharmacoeconomics analyses were not performed., Months 5-7|Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period, Efficacy and pharmacoeconomics analyses were not performed., Baseline, Months 5-7 | Secondary: Number of Participants Assessed for AEs, The adverse events are captured in the adverse event and serious adverse event section of this database., Month 1 to 15 day follow up post month 7|The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants, A marked laboratory abnormality was defined as a test result that was outside of the marked abnormality range and that also represented a clinically relevant change from baseline of at least a designated amount., Baseline, Month 1 to Month 7 |
| Sponsor/Collaborators: | Sponsor: Hoffmann-La Roche |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 260 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2007-03 |
| Completion Date: | 2007-12 |
| Results First Posted: | 2011-12-14 |
| Last Update Posted: | 2011-12-14 |
| Locations: | Birmingham, Alabama, United States|Rainbow City, Alabama, United States|Hot Springs, Arizona, United States|Fairfield, California, United States|Los Alamitos, California, United States|Los Angeles, California, United States|Mountain View, California, United States|Riverside, California, United States|San Diego, California, United States|Simi Valley, California, United States|Whittier, California, United States|Lakewood, Colorado, United States|Brandon, Florida, United States|Hudson, Florida, United States|Lauderdale Lakes, Florida, United States|Miami, Florida, United States|Ocala, Florida, United States|Palm Beach Gardens, Florida, United States|Augusta, Georgia, United States|Gurnee, Illinois, United States|Fort Wayne, Indiana, United States|Detroit, Michigan, United States|Pontiac, Michigan, United States|Sparks, Nevada, United States|New Brunswick, New Jersey, United States|Bronx, New York, United States|Brooklyn Center, New York, United States|Brooklyn, New York, United States|Flushing, New York, United States|Orchard Park, New York, United States|Williamsville, New York, United States|Raleigh, North Carolina, United States|Toledo, Ohio, United States|Tulsa, Oklahoma, United States|Lancaster, Pennsylvania, United States|Lewistown, Pennsylvania, United States|Philadelphia, Pennsylvania, United States|West Homestead, Pennsylvania, United States|Columbia, South Carolina, United States|Orangeburg, South Carolina, United States|Corpus Christi, Texas, United States|Houston, Texas, United States|Chesapeake, Virginia, United States|Fairfax, Virginia, United States |
| URL: | https://clinicaltrials.gov/show/NCT00422513 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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