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Clinical Trial Details

Trial ID: L1138
Source ID: NCT02661295
Associated Drug: Ferric Citrate
Title: A Study of Ferric Citrate to Improve Inflammation and Lipid Levels
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02661295/results
Conditions: End Stage Renal Disease|Hyperphosphatemia|Chronic Inflammation
Interventions: DRUG: Ferric Citrate
Outcome Measures: Primary: Percent Change in Total Cholesterol, Percent change in total cholesterol (mg/dl) from Baseline to Month 6., Baseline, Month 6|Percent Change in LDL-Cholesterol, Percent change in low-density lipoprotein (LDL) cholesterol (mg/dl) from baseline to Month 6, Baseline, Month 6|Percent Change in HDL Cholesterol, Percent change in high-density lipoprotein (HDL) cholesterol (mg/dl) from baseline to Month 6., Baseline, Month 6|Percent Change in Triglycerides, Percent change in triglycerides (mg/dl) from baseline to Month 6., Baseline, Month 6|Percent Change in TNF-alpha, Percent change in tumor necrosis factor (TNF)-alpha (pg/ml) from Baseline to Month 6., Baseline, Month 6|Percent Change in IL-6, Percent change in interleukin 6 (IL-6) (pg/ml) from baseline to Month 6, Baseline, Month 6|Percent Change in IL-8, Percent change in interleukin 8 (IL-8) (pg/ml) from baseline to Month 6., Baseline, Month 6|Percent Change in Ferritin, Percent change in ferritin (ng/ml) from baseline to Month 6., Baseline, Month 6|Percent Change in C-reactive Protein, Percent change in C-reactive Protein (mg/L) from baseline to Month 6., Baseline, Month 6|Percent Change in Homocysteine, Percent change in homocysteine (micromol/L) from baseline to Month 6., Baseline, Month 6|Change in Intravenous Iron Use, Change in intravenous iron use (mg) from Baseline to Month 6., Baseline, Month 6 | Secondary: Percent Change in Calcium, Percent change in calcium (mg/dL) from baseline to Month 6., Baseline, Month 6|Percent Change in Phosphorus, Percent change in phosphorus (md/dl) from baseline to Month 6., Baseline, Month 6|Percent Change in Parathyroid Hormone (PTH), Percent change in PTH (pg/ml) from baseline to Month 6., Baseline, Month 6
Sponsor/Collaborators: Sponsor: Winthrop University Hospital | Collaborators: Keryx Biopharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 38
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2015-07
Completion Date: 2018-03-15
Results First Posted: 2023-04-20
Last Update Posted: 2023-04-20
Locations: Winthrop University Hospital, Mineola, New York, 11501, United States
URL: https://clinicaltrials.gov/show/NCT02661295