Logo 1 Logo 2

Clinical Trial Details

Trial ID: L1370
Source ID: NCT01554982
Associated Drug: Ferric Citrate
Title: A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01554982/results
Conditions: End Stage Renal Disease|Kidney Failure|Renal Failure|Hyperphosphatemia|ESRD
Interventions: DRUG: ferric citrate
Outcome Measures: Primary: Safety Parameters, Safety was assessed by recording and monitoring adverse events (AEs), serious adverse events (SAEs), and sequential laboratory data. Rates of AEs were summarized by system organ class, preferred term, severity, and suspected relationship to KRX-0502 (ferric citrate)., 48 Weeks | Other: Serum Phosphorus- Baseline, Baseline|Serum Phosphorus- Week 48, 48 weeks|Ferritin- Baseline, Baseline|Ferritin- Week 48, 48 weeks|Transferrin Saturation (TSAT) - Baseline, Baseline|TSAT- Week 48, 48 weeks|Hemoglobin- Baseline, Baseline|Hemoglobin- Week 48, 48 weeks|IV Iron Use, Percent of subjects with No IV iron intake from first dose of study drug to Week 48, 48 weeks
Sponsor/Collaborators: Sponsor: Keryx Biopharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 168
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-08
Completion Date: 2014-08
Results First Posted: 2016-07-13
Last Update Posted: 2016-07-13
Locations: Veterans Administration Greater Los Angeles Health Care System, Los Angeles, California, 90073, United States|University of Colorado, Aurora, Colorado, 80045, United States|Western Nephrology and Metabolic Bone Disease, PC, Westminster, Colorado, 80031, United States|Kidney Care Associates, LLC, Augusta, Georgia, 30909, United States|Circle Medical Management, Chicago, Illinois, 60607, United States|DaVita Dialysis Unit 494/Nephrology Specialists, PC, Michigan City, Indiana, 46360, United States|Dept of Internal Medicine, Nephrology & Hypertension, New Orleans, Louisiana, 70112, United States|Washington Nephrology Associates, Bethesda, Maryland, 20814, United States|Tufts Medical Center, Boston, Massachusetts, 02111, United States|Western New England Renal & Transplant Associates, PC, Springfield, Massachusetts, 01107, United States|Nephrology Hypertension Clinic, PC, Dearborn,, Michigan, 48124, United States|Henry Ford Hospital, Detroit, Michigan, 48202, United States|Rochester Hills DaVita Dialysis, Pontiac, Michigan, 48341, United States|Asheville Kidney Center, Asheville, North Carolina, 28801, United States|Metrolina Nephrology Associates, PA, Charlotte, North Carolina, 28207, United States|Duke University Dept of Medicine/Nephrology, Durham, North Carolina, 27705, United States|Piedmont Dialysis Center, Winston-Salem, North Carolina, 27101, United States|Clinical Research Limited, Canton, Ohio, 44718, United States|University of Cincinnati, Cincinnati, Ohio, 45267, United States|University of Pennsylvania Health System, Philadelphia, Pennsylvania, 19104, United States|Southeast Renal Research Institute Nephrology Associates, Chattanooga, Tennessee, 37408, United States|Nephrology Associates, PC, Nashville, Tennessee, 37205, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States|UT Southwestern Medical Center at Dallas, Dallas, Texas, 75390, United States|Kidney Associates, PLLC, Houston, Texas, 77030, United States|Med Center Dialysis, Houston, Texas, 77030, United States|Kidney Specialists of North Houston, PLLC, Houston, Texas, 77384, United States|University of Vermont/ Fletcher Allen Health Care: Renal Services, Burlington, Vermont, 05401, United States|Nephrology Clinical Research Center, Charlottesville, Virginia, 22908, United States|Clinical Research & Consulting Center, LLC, Fairfax, Virginia, 22030, United States|Nephrology Associates of Northern Virginia, Inc., Fairfax, Virginia, 22033, United States|Butler Farms Dialysis, Hampton, Virginia, 23666, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States|RCMI-Clinical Research Center, Rio Piedras, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT01554982

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress