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Clinical Trial Details

Trial ID: L1027
Source ID: NCT02253654
Associated Drug: Epoetin Alfa
Title: Evaluation of Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02253654/results
Conditions: Renal Insufficiency, Chronic|Anemia|Renal Dialysis|Erythrocyte Transfusion
Interventions: DRUG: Epoetin alfa
Outcome Measures: Primary: Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period, Hemoglobin was measured every 2 weeks during the evaluation period. The percentage of these measurements that were within the range of 10-11 g/dL was calculated for each participant., The evaluation period (weeks 13-37) | Secondary: Hemoglobin Concentration at Each Visit, Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37|Percentage of Participants With Transfusion Events Overall and During Each Study Period, The percentage of participants who received red blood cell (RBC) transfusions during the study and during each study period., Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41|Hemoglobin Rate of Change at Each Visit, Hemoglobin rate of change (ROC) was calculated for each visit using the following formula: ROC = (current visit hemoglobin value - previous visit hemoglobin value) / number of days between each visit \* 14. A positive value indicates a rate of rise and a negative value indicates a rate of decline., Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37|Hemoglobin Intra-subject Variability, Intra-subject variability was defined for each participant as the standard deviation (SD) of all of the hemoglobin concentrations during the evaluation period for the participant. The mean intra-subject SD for all participants is the sum of the intra-subject SDs divided by the total number of participants evaluated., The evaluation period (weeks 13 to 37)|Percentage of Participants With Hemoglobin Excursions at Each Visit, An excursion is identified as an event when a hemoglobin concentration fell below or exceeded the pre-specified thresholds of: - \< 9.0 g/dL, or - \> 11.0 g/dL, or - \> 12.0 g/dL. The percentage of participants with any excursions and excursions in each subcategory at each time point and overall during the study are reported., Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37|Weekly Epoetin Alfa Dose at Each Visit, Weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35|Number of RBC Units Transfused Overall and During Each Study Period, The number of red blood cell (RBC) units transfused during the study and during each study period., Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41
Sponsor/Collaborators: Sponsor: Amgen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 216
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2015-04-01
Completion Date: 2016-05-25
Results First Posted: 2017-05-12
Last Update Posted: 2017-05-19
Locations: Research Site, Cerritos, California, 90703, United States|Research Site, Glendale, California, 91204, United States|Research Site, Los Angeles, California, 90022, United States|Research Site, Los Angeles, California, 90057, United States|Research Site, Montebello, California, 90640, United States|Research Site, Riverside, California, 92501, United States|Research Site, San Diego, California, 92115, United States|Research Site, Simi Valley, California, 93065, United States|Research Site, Vacaville, California, 95687, United States|Research Site, Whittier, California, 90606, United States|Research Site, Miami Gardens, Florida, 33169, United States|Research Site, Miami, Florida, 33150, United States|Research Site, Pembroke Pines, Florida, 33025, United States|Research Site, Macon, Georgia, 31217, United States|Research Site, Statesboro, Georgia, 30458, United States|Research Site, Merrillville, Indiana, 46410, United States|Research Site, Michigan City, Indiana, 46360, United States|Research Site, Detroit, Michigan, 48202, United States|Research Site, Pontiac, Michigan, 48341, United States|Research Site, Roseville, Michigan, 48066, United States|Research Site, Kansas City, Missouri, 64111, United States|Research Site, Lincoln, Nebraska, 68510, United States|Research Site, Astoria, New York, 11102, United States|Research Site, Brooklyn, New York, 11235, United States|Research Site, Rosedale, New York, 11422, United States|Research Site, The Bronx, New York, 10461, United States|Research Site, Carrboro, North Carolina, 27510, United States|Research Site, Wilmington, North Carolina, 28401, United States|Research Site, Meadville, Pennsylvania, 16335, United States|Research Site, Philadelphia, Pennsylvania, 19106, United States|Research Site, Houston, Texas, 77004, United States|Research Site, Houston, Texas, 77070, United States|Research Site, San Antonio, Texas, 78229, United States|Research Site, Burlington, Vermont, 05401, United States|Research Site, Hampton, Virginia, 23666, United States|Research Site, Norfolk, Virginia, 23502, United States|Research Site, Toa Baja, 00949, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT02253654