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Clinical Trial Details

Trial ID: L0715
Source ID: NCT00434330
Associated Drug: Peginesatide
Title: Peginesatide for Maintenance Treatment of Anemia in Participants on Hemodialysis
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00434330/results
Conditions: Anemia|Chronic Kidney Disease|Chronic Renal Failure
Interventions: DRUG: peginesatide|DRUG: peginesatide|DRUG: peginesatide|DRUG: peginesatide|DRUG: peginesatide|DRUG: peginesatide
Outcome Measures: Primary: Mean Hemoglobin Throughout the Trial and Mean Hemoglobin Change From Baseline Throughout the Trial., The Baseline hemoglobin was the mean of the four most recent mid- or end-of-week predialysis hemoglobin values collected prior to study start. Study start was the date of the first dose of peginesatide injection in participants who did not have a one-week transition period, or the date when Epoetin treatment was first withheld in participants who did have a one-week transition period., Baseline and Weeks 2-29 | Other: Proportion of Participants With Hemoglobin Within 1.0 g/dL Below Baseline to 1.5 g/dL Above Baseline Throughout the Trial (Weeks 2-29), Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within 1 g/dL below to 1.5 g/dL above baseline) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period., Weeks 2 to 29|Proportion of Participants Who Maintained Hemoglobin Within 10 to 12.5 g/dL Throughout the Trial, Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within the range of 10 g/dL to 12.5 g/dL) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period., Weeks 2 to 29|Proportion of Participants Who Maintain Hemoglobin Within 9.5 to 13.0 g/dL Throughout the Trial, Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within the range of 9.5 g/dL to 13.0 g/dL) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period., Weeks 2 to 29
Sponsor/Collaborators: Sponsor: Affymax
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 91
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2006-12
Completion Date: 2008-04
Results First Posted: 2012-05-28
Last Update Posted: 2012-06-29
Locations: Research Facility, Burgas, 8000, Bulgaria|Research Facility, Pleven, 5800, Bulgaria|Research Facility, Plovdiv, 4003, Bulgaria|Research Facility, Rousse, 7002, Bulgaria|Research Facility, Sofia, 1527, Bulgaria|Research Facility, Sofia, 1606, Bulgaria|Research Facility, Sofia, 1709, Bulgaria|Research Facility, Varna, 9010, Bulgaria|Research Facility, Veliko Tarnovo, 5000, Bulgaria|Research Facility, Arad, 310017, Romania|Research Facility, Bacau, 600114, Romania|Research Facility, Bucuresti, Romania|Research Facility, Iasi, 700503, Romania|Research Facility, Timisoara, 300736, Romania|Research Facility, London, SE5 9RS, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00434330