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Clinical Trial Details

Trial ID: L1487
Source ID: NCT01191255
Associated Drug: Ferric Citrate, Ca Acetate, Sevelamer Carbonate, Placebo
Title: A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01191255/results
Conditions: Hyperphosphatemia|Kidney Failure
Interventions: DRUG: ferric citrate, ca acetate, sevelamer carbonate, placebo
Outcome Measures: Primary: Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56), Patients who completed the 52-week Safety Assessment Period (SAP) on KRX-0502 (ferric citrate) were randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or Placebo for 4 weeks., 4 weeks | Secondary: Change in Mean Serum Ferritin From Baseline to Week 52, 52 weeks|Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52), 52 weeks|IV Iron Analysis, Full Analysis Population, cumulative IV Iron administration from Baseline to the end of the Safety Assessment Period (Week 52), 52 weeks|ESA Analysis, Full analysis population, cumulative Erythropoiesis-stimulating agent (ESA) administration from baseline to the end of the Safety Assessment Period (Week 52), 52 weeks
Sponsor/Collaborators: Sponsor: Keryx Biopharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 441
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2010-10
Completion Date: 2013-02
Results First Posted: 2014-12-10
Last Update Posted: 2014-12-10
Locations: Southwest Clinical Research Institute, LLC, Tempe, Arizona, 85284, United States|Tower Nephrology Medical Group, Los Angeles, California, 90048, United States|Veterans Administration Greater Los Angeles Healthcare System, West Los Angeles, Los Angeles, California, 90073, United States|Apex Research of Riverside, Riverside, California, 92505, United States|American Institute of Research, Whittier, California, 90603, United States|University of Colorado Denver, Aurora, Colorado, 80045, United States|Western Nephrology, Westminster, Colorado, 80031, United States|PAB Clinical Research, Brandon, Florida, 33511, United States|Mayo Clinic, Jacksonville, Florida, 32216, United States|ASA Clinical Research, LLC, Jupiter, Florida, 33458, United States|Ocala Kidney Group, Ocala, Florida, 34471, United States|Pines Clinical Research, Inc., Pembroke Pines, Florida, 33028, United States|Kidney Care Associates, LLC, Augusta, Georgia, 30901, United States|Atlanta Nephrology Referral Center, Decatur, Georgia, 30030, United States|Circle Medical Management, Chicago, Illinois, 60607, United States|Nephrology Specialists, PC, Michigan City, Indiana, 46360, United States|LSU Health Sciences Center Section of Nephrology and Hypertension Department of Internal Medicine, New Orleans, Louisiana, 70112, United States|Rockville Dialysis Center, Rockville, Maryland, 20850, United States|Tufts Medical Center, Boston, Massachusetts, 02111, United States|Pioneer Valley Nephrology, Holyoke, Massachusetts, 01040, United States|Western New England Renal & Transplant Associates, Springfield, Massachusetts, 01107, United States|Henry Ford Hospital, Detroit, Michigan, 48202, United States|Michigan Kidney Consultants, PC, Pontiac, Michigan, 48341, United States|Nephrology Hypertension Clinic, Southgate, Michigan, 48195, United States|Kansas City VA Medical Center, Kansas City, Missouri, 64128, United States|Brookdale Physician's Dialysis Associates, Brooklyn, New York, 11212, United States|Mountain Kidney and Hypertension Associates, PA, Asheville, North Carolina, 28801, United States|Metrolina Nephrology Associates, PA, Charlotte, North Carolina, 28207, United States|Duke University Medical Center Division of Nephrology, Durham, North Carolina, 27705, United States|Trial Management Associates, Wilmington, North Carolina, 28401, United States|Wake Forest University School of Medicine, Winston Salem, North Carolina, 27157, United States|Clinical Research Limited, Canton, Ohio, 44718, United States|Division of Nephrology and Hypertension Department of Internal Medicine University of Cincinnati College of Medicine, Cincinnati, Ohio, 45267, United States|Cleveland Clinic Foundation Q7-150 Nephrology, Cleveland, Ohio, 44195, United States|The Ohio State University Division of Nephrology, Columbus, Ohio, 43210, United States|DaVita, Oklahoma City, Oklahoma, 73116, United States|University of Pennsylvania Health System, Philadelphia, Pennsylvania, 19104, United States|Southeast Renal Research Institute Nephrology Associates, Chattanooga, Tennessee, 37404, United States|Nephrology Associates, PC, Nashville, Tennessee, 37205, United States|Vanderbilt University Medical Center Clinical Trials Center, Nashville, Tennessee, 37232-1371, United States|UT Southwestern Medical Center at Dallas, Dallas, Texas, 75390, United States|Kidney Associates, Houston, Texas, 77030, United States|Nephrology, PA, Houston, Texas, 77030, United States|Kidney Specialists of North Houston, PLLC, The Woodlands, Texas, 77384, United States|University of Utah Health Sciences Center, Salt Lake City, Utah, 84132, 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|Peninsula Kidney Associates, Hampton, Virginia, 23666, United States|McGuire VA Medical Center, Richmond, Virginia, 23249, United States|Medical College of Wisconsin Froedert Memorial Lutheran Hospital Division of Nephrology, Milwaukee, Wisconsin, 53226, United States|Department of Nephrology and Hypertension Brazilai Medical Center, Ashkelon, Israel|Tel Aviv Sourasky Medical Center Nephrology Department, Tel Aviv, Israel|RCMI-Clinical Research Center Medical Sciences Campus University of Puerto Rico, Rio Piedras, 00936-5067, Puerto Rico|Puerto Rico Renal Health & Research Center, Inc/ Atlantic Healthcare Group, Inc, Trujillo Alto, 00976, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT01191255

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress