| Trial ID: | L1714 |
| Source ID: | NCT00752609
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| Associated Drug: |
Peginesatide
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| Title: |
Safety and Efficacy of Peginesatide Injection for the Maintenance of Anemia in Chronic Renal Failure Participants Who Are on Hemodialysis or Do Not Require Dialysis and Previously Treated With Darbepoetin Alfa.
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| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT00752609/results
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| Conditions: |
Anemia
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| Interventions: |
DRUG: Peginesatide
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| Outcome Measures: |
Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period, Mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin from Weeks 19 to 24)., Baseline and Week 19 to Week 24. | Secondary: Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period, Mean hemoglobin was calculated from measurements taken during the Evaluation Period from Week 19 to Week 24. The target hemoglobin range was between 10.0 to 12.0 g/dL. The 95% confidence interval was calculated from the normal approximation with continuity correction., Week 19 to Week 24|Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL, Percentage of participants with a mean change in hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin measured at Weeks 19 to 24) of less than or equal ± 1 g/dL. The 95% confidence interval was calculated from the normal approximation with continuity correction., Baseline and Week 19 to Week 24.|Percentage of Participants With Red Blood Cell Transfusions, The percentage of participants who received one or more red blood cell transfusions, including packed red blood cells and whole blood transfusions, during the Titration Period (Weeks 0 - 18) and Evaluation Period (Weeks 19 -24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction., Up to 24 weeks.|Mean Hemoglobin During 4-week Intervals, Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24)., Up to 24 weeks.|Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals., Percentage of participants with mean hemoglobin levels falling between the target level of 10.0 to 12.0 g/dL during 4-week study intervals. Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction., Up to 24 weeks.|Percentage of Participants With Dose Adjustments During the Study, The peginesatide dose was adjusted to maintain Hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline during the Titration Period (Weeks 0-18) and Evaluation Period (Weeks 19-24). A dose was classified as adjusted if it was not within 20% of the previous dose. A dose was classified as increased or decreased if it was \>20% higher or \>20% lower respectively, than the previous dose., From Week 4 to Week 20
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| Sponsor/Collaborators: |
Sponsor: Takeda | Collaborators: Affymax
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
102
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2008-09
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| Completion Date: |
2009-12
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| Results First Posted: |
2012-07-27
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| Last Update Posted: |
2012-07-27
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| Locations: |
Los Angeles, California, United States|Sacramento, California, United States|San Diego, California, United States|Middlebury, Connecticut, United States|Lauderdale Lakes, Florida, United States|Shreveport, Louisiana, United States|Dearborn, Michigan, United States|Columbus, Mississippi, United States|Mineola, New York, United States|Arlington, Texas, United States
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| URL: |
https://clinicaltrials.gov/show/NCT00752609
|
