A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
NCT ID: NCT01191255
Last Updated: 2014-12-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
441 participants
INTERVENTIONAL
2010-10-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Active Control
PhosLo (calcium acetate) Renvela (sevelamer carbonate)
ferric citrate, ca acetate, sevelamer carbonate, placebo
All intervention doses will be based on serum phosphorus levels and/or drug label requirements
Placebo
Placebo
ferric citrate, ca acetate, sevelamer carbonate, placebo
All intervention doses will be based on serum phosphorus levels and/or drug label requirements
KRX-0502 (Ferric Citrate)
ferric citrate
ferric citrate, ca acetate, sevelamer carbonate, placebo
All intervention doses will be based on serum phosphorus levels and/or drug label requirements
Interventions
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ferric citrate, ca acetate, sevelamer carbonate, placebo
All intervention doses will be based on serum phosphorus levels and/or drug label requirements
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥18 years
3. On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening
4. Serum phosphorus ≥6.0 mg/dL for study entry
5. Taking less than 3-18 pills/day of current phosphate binder
6. Willing to be discontinued from current phosphate binder(s) and initiated on ferric citrate
7. Willing and able to give informed consent
8. Life expectancy \>1 year
Exclusion Criteria
2. Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
3. History of multiple drug allergies or intolerances
4. History of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by CCC)
5. Previous intolerance to oral ferric citrate
6. Intolerance to oral iron-containing products
7. Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
8. Inability to tolerate oral drug intake
9. Intolerance to calcium acetate and sevelamer carbonate
10. Any other medical condition that renders the patient unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the patient
11. Receipt of any investigational drug within 30 days of Screening Visit (Visit 0)
12. Inability to cooperate with study personnel or history of noncompliance
13. Unsuitable for this trial per Investigator's 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
Samuel Blumenthal, MD
Role: STUDY_CHAIR
Collaborative Study Group
Locations
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Southwest Clinical Research Institute, LLC
Tempe, Arizona, United States
Tower Nephrology Medical Group
Los Angeles, California, United States
Veterans Administration Greater Los Angeles Healthcare System, West Los Angeles
Los Angeles, California, United States
Apex Research of Riverside
Riverside, California, United States
American Institute of Research
Whittier, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Western Nephrology
Westminster, Colorado, United States
PAB Clinical Research
Brandon, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
ASA Clinical Research, LLC
Jupiter, Florida, United States
Ocala Kidney Group
Ocala, Florida, United States
Pines Clinical Research, Inc.
Pembroke Pines, Florida, United States
Kidney Care Associates, LLC
Augusta, Georgia, United States
Atlanta Nephrology Referral Center
Decatur, Georgia, United States
Circle Medical Management
Chicago, Illinois, United States
Nephrology Specialists, PC
Michigan City, Indiana, United States
LSU Health Sciences Center Section of Nephrology and Hypertension Department of Internal Medicine
New Orleans, Louisiana, United States
Rockville Dialysis Center
Rockville, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Pioneer Valley Nephrology
Holyoke, Massachusetts, United States
Western New England Renal & Transplant Associates
Springfield, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Michigan Kidney Consultants, PC
Pontiac, Michigan, United States
Nephrology Hypertension Clinic
Southgate, Michigan, United States
Kansas City VA Medical Center
Kansas City, Missouri, United States
Brookdale Physician's Dialysis Associates
Brooklyn, New York, United States
Mountain Kidney and Hypertension Associates, PA
Asheville, North Carolina, United States
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, United States
Duke University Medical Center Division of Nephrology
Durham, North Carolina, United States
Trial Management Associates
Wilmington, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Clinical Research Limited
Canton, Ohio, United States
Division of Nephrology and Hypertension Department of Internal Medicine University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
Cleveland Clinic Foundation Q7-150 Nephrology
Cleveland, Ohio, United States
The Ohio State University Division of Nephrology
Columbus, Ohio, United States
DaVita
Oklahoma City, Oklahoma, 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 Clinical Trials Center
Nashville, Tennessee, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
Kidney Associates
Houston, Texas, United States
Nephrology, PA
Houston, Texas, United States
Kidney Specialists of North Houston, PLLC
The Woodlands, Texas, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 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
Peninsula Kidney Associates
Hampton, Virginia, United States
McGuire VA Medical Center
Richmond, Virginia, United States
Medical College of Wisconsin Froedert Memorial Lutheran Hospital Division of Nephrology
Milwaukee, Wisconsin, 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, PR, Puerto Rico
Puerto Rico Renal Health & Research Center, Inc/ Atlantic Healthcare Group, Inc
Trujillo Alto, PR, Puerto Rico
Countries
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References
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Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
Rodby RA, Umanath K, Niecestro R, Bond TC, Sika M, Lewis J, Dwyer JP; Collaborative Study Group. Ferric Citrate, an Iron-Based Phosphate Binder, Reduces Health Care Costs in Patients on Dialysis Based on Randomized Clinical Trial Data. Drugs R D. 2015 Sep;15(3):271-9. doi: 10.1007/s40268-015-0103-y.
Related Links
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Sponsor Website
Other Identifiers
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KRX-0502-304
Identifier Type: -
Identifier Source: org_study_id
NCT01510106
Identifier Type: -
Identifier Source: nct_alias