A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis
NCT ID: NCT01554982
Last Updated: 2016-07-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
168 participants
INTERVENTIONAL
2012-08-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ferric Citrate
Open label extension of those completing study KRX-0304
ferric citrate
Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Interventions
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ferric citrate
Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Willing and able to give informed consent
Exclusion Criteria
2. Any subject in Study KRX-0502-304 SAP who early terminated from the trial
3. Any subject who participated in Study KRX-0502-304 but declined EAP
4. Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
5. History of malignancy in the last five years
6. Previous intolerance to KRX-0502 (ferric citrate)
7. Intolerance to oral iron-containing products
8. Absolute requirement for oral iron therapy
9. Absolute requirement for Vitamin C (multivitamins \[Nephrocaps, Renaphro, etc.\] allowed)
10. Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
11. Inability to tolerate oral drug intake
12. Any other medical condition that rendered the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject
13. Inability to cooperate with study personnel or history of noncompliance
14. Unsuitable for this trial per Principal Investigator's (PI) clinical judgment.
18 Years
ALL
No
Sponsors
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Keryx Biopharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Julia B Lewis, MD
Role: STUDY_CHAIR
Collaborative Study Group
Locations
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Veterans Administration Greater Los Angeles Health Care System
Los Angeles, California, United States
University of Colorado
Aurora, Colorado, United States
Western Nephrology and Metabolic Bone Disease, PC
Westminster, Colorado, United States
Kidney Care Associates, LLC
Augusta, Georgia, United States
Circle Medical Management
Chicago, Illinois, United States
DaVita Dialysis Unit 494/Nephrology Specialists, PC
Michigan City, Indiana, United States
Dept of Internal Medicine, Nephrology & Hypertension
New Orleans, Louisiana, United States
Washington Nephrology Associates
Bethesda, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Western New England Renal & Transplant Associates, PC
Springfield, Massachusetts, United States
Nephrology Hypertension Clinic, PC
Dearborn, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Rochester Hills DaVita Dialysis
Pontiac, Michigan, United States
Asheville Kidney Center
Asheville, North Carolina, United States
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, United States
Duke University Dept of Medicine/Nephrology
Durham, North Carolina, United States
Piedmont Dialysis Center
Winston-Salem, North Carolina, United States
Clinical Research Limited
Canton, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Southeast Renal Research Institute Nephrology Associates
Chattanooga, Tennessee, United States
Nephrology Associates, PC
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
Kidney Associates, PLLC
Houston, Texas, United States
Med Center Dialysis
Houston, Texas, United States
Kidney Specialists of North Houston, PLLC
Houston, Texas, United States
University of Vermont/ Fletcher Allen Health Care: Renal Services
Burlington, Vermont, United States
Nephrology Clinical Research Center
Charlottesville, Virginia, United States
Clinical Research & Consulting Center, LLC
Fairfax, Virginia, United States
Nephrology Associates of Northern Virginia, Inc.
Fairfax, Virginia, United States
Butler Farms Dialysis
Hampton, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
RCMI-Clinical Research Center
Rio Piedras, PR, Puerto Rico
Countries
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Other Identifiers
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KRX-0502-307
Identifier Type: -
Identifier Source: org_study_id
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