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Clinical Trial Details

Trial ID: L0467
Source ID: NCT01428154
Associated Drug: Darbepoetin Alfa
Title: Study to Evaluate Darbepoetin Alfa in Pediatric Subjects With Anemia Due to Chronic Kidney Disease
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Anemia|Chronic Kidney Disease
Interventions: DRUG: Darbepoetin alfa
Outcome Measures: Primary: Number of subjects with clinically significant changes in physical examinations, laboratory safety tests, and vital signs, Assessed over 29 days|Number of subjects with treatment-emergent adverse events, Assessed over 29 days | Secondary: Maximum observed concentration (Cmax) of darbepoetin alfa, Assessed predose and at 6, 24, 48, 72, and 168 hours postdose|Time at which maximum concentration is observed (Tmax) of darbepoetin alfa, Assessed predose and at 6, 24, 48, 72, and 168 hours postdose|Area under the concentration curve (AUC) of darbepoetin alfa, Assessed predose and at 6, 24, 48, 72, and 168 hours postdose|Terminal half-life (t½) of darbepoetin alfa, Assessed predose and at 6, 24, 48, 72, and 168 hours postdose|Clearance (CL) of darbepoetin alfa, Assessed predose and at 6, 24, 48, 72, and 168 hours postdose|Change in reticulocytes, Assessed from baseline to day 8|Change in reticulocytes, Assessed from baseline to day 29|Change in hemoglobin concentration, Assessed from baseline to day 8|Change in hemoglobin concentration, Assessed from baseline to day 29|Change in iron, Assessed from baseline to day 29|Change in ferritin, Assessed from baseline to day 29|Change in transferrin saturation, Assessed from baseline to day 29
Sponsor/Collaborators: Sponsor: Amgen
Gender: ALL
Age: CHILD
Phases: PHASE1
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-04
Completion Date: 2016-11
Results First Posted:
Last Update Posted: 2016-06-17
Locations:
URL: https://clinicaltrials.gov/show/NCT01428154