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Clinical Trial Details

Trial ID: L1346
Source ID: NCT03256838
Associated Drug: Ferric Citrate
Title: Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Kidney Failure, Chronic|End-stage Renal Disease|Phosphorus Metabolism Disorders|Hyperphosphatemia
Interventions: DRUG: Ferric Citrate
Outcome Measures: Primary: Number of subjects with treatment-emergent adverse events (TEAEs), Number of subjects with treatment-emergent adverse events (TEAEs), 13 months|Percentage of subjects with treatment-emergent adverse events (TEAEs), Percentage of subjects with treatment-emergent adverse events (TEAEs), 13 months | Secondary: Serum Phosphorus, Serum Phosphorus will be assessed by time-course changes of serum phosphorus levels and proportion of subjects achieved target range of serum phosphorus (\>=3.5 mg/dL and \<=5.5. mg/dL) from baseline to the end-of-treatment., 13 months | Other: Serum calcium, Time-course changes of serum calcium from baseline., 13 months|Intact plasma parathyroid hormone (iPTH), Time-course changes of intact plasma parathyroid hormone (iPTH) from baseline., 13 months|Ferritin, Time-course changes of ferritin from baseline., 13 months|Transferring saturation (TSAT) percentage, Time-course changes of transferring saturation (TSAT) percentage from baseline., 13 months|Serum iron, Time-course changes of serum iron from baseline., 13 months|Total iron-binding capacity (TIBC), Time-course changes of total iron-binding capacity (TIBC) from baseline., 13 months|Hemoglobin, Time-course changes of hemoglobin from baseline., 13 months|Dose of IV iron, Time-course changes of dose of IV iron from baseline., 13 months|Dose of erythropoiesis stimulating agents (ESA), Time-course changes of dose of erythropoiesis stimulating agents (ESA) from baseline., 13 months|Treatment adherence, Prescribed dose and the dose actually taken at each time point will be calculated., 13 months
Sponsor/Collaborators: Sponsor: Panion & BF Biotech Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 202
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2017-04-12
Completion Date: 2019-05-31
Results First Posted:
Last Update Posted: 2020-01-13
Locations: Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, 80756, Taiwan|Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital, Kaohsiung, 83301, Taiwan|Division of Nephrology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital, Keelung, 20401, Taiwan|Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital, New Taipei City, 22060, Taiwan|Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, 40705, Taiwan|Division of Nephrology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, 10002, Taiwan|Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital, Taipei, 11042, Taiwan|Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, 11101, Taiwan|Division of Nephrology, Department of Internal Medicine, Taipei Veterans General Hospital, Taipei, 11217, Taiwan
URL: https://clinicaltrials.gov/show/NCT03256838