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Clinical Trial Details

Trial ID: L0528
Source ID: NCT00239642
Associated Drug: Venofer (Iron Sucrose Injection)
Title: Safety and Efficacy of Iron Sucrose in Children
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00239642/results
Conditions: Anemia|Chronic Kidney Disease
Interventions: DRUG: Venofer (iron sucrose injection)|DRUG: Venofer (iron sucrose injection)|DRUG: Venofer (iron sucrose injection)
Outcome Measures: Primary: Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event, Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm, baseline through week 12 | Secondary: Number of Subjects Achieving Clinical Success, Summary of the Number of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and Stable EPO Dosing (±25% of Baseline Dose), anytime during the 12 week post-baseline period|Percentage (%) of Subjects Achieving Clinical Success, Summary of the Percentage (%) of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and stable EPO Dosing (±25% of Baseline Dose), anytime during the 12 week post-baseline period|Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive, Summary of the Number of Subjects with Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, anytime during the 12-week post-baseline period|Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive, Summary of the Percentage (%) of Subjects with Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive, anytime during the 12 week post-baseline period|Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive, Summary of the Proportion of Subjects with transferrin saturation (TSAT) between 20% and 50%, Inclusive, anytime during the 12 week post-baseline period|Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive, Summary of the Percentage (%) of Subjects with TSAT between 20% and 50%, Inclusive, anytime during the 12 week post-baseline period|Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline, Summary of the Proportion of Subjects with Stable erythropoietin (EPO) Dosing or a Decrease \>25% in EPO dose from Baseline, anytime during the 12 week post-baseline period|Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline, Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease \>25% in EPO Dose from Baseline, anytime during the 12 week post-baseline period
Sponsor/Collaborators: Sponsor: American Regent, Inc.
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE4
Enrollment: 141
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2005-07
Completion Date: 2010-04
Results First Posted: 2012-01-10
Last Update Posted: 2021-11-17
Locations: Luitpold Pharmaceutials, Norristown, Pennsylvania, 19403, United States
URL: https://clinicaltrials.gov/show/NCT00239642