A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
A Three-Period, 58-Week Safety and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) on Dialysis
1 other identifier
interventional
441
3 countries
56
Brief Summary
This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2010
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2010
CompletedFirst Posted
Study publicly available on registry
August 30, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
December 10, 2014
CompletedDecember 10, 2014
December 1, 2014
2.3 years
August 26, 2010
October 4, 2014
December 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
52 weeks
ESA Analysis
52 weeks
Study Arms (3)
Active Control
ACTIVE COMPARATORPhosLo (calcium acetate) Renvela (sevelamer carbonate)
Placebo
PLACEBO COMPARATORPlacebo
KRX-0502 (Ferric Citrate)
EXPERIMENTALferric citrate
Interventions
All intervention doses will be based on serum phosphorus levels and/or drug label requirements
Eligibility Criteria
You may qualify if:
- Males or non-pregnant, non-breast-feeding females
- Age ≥18 years
- On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening
- Serum phosphorus ≥6.0 mg/dL for study entry
- Taking less than 3-18 pills/day of current phosphate binder
- Willing to be discontinued from current phosphate binder(s) and initiated on ferric citrate
- Willing and able to give informed consent
- Life expectancy \>1 year
You may not qualify if:
- Parathyroidectomy within six months prior to Screening
- Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
- History of multiple drug allergies or intolerances
- History of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by CCC)
- Previous intolerance to oral ferric citrate
- Intolerance to oral iron-containing products
- Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
- Inability to tolerate oral drug intake
- Intolerance to calcium acetate and sevelamer carbonate
- 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
- Receipt of any investigational drug within 30 days of Screening Visit (Visit 0)
- Inability to cooperate with study personnel or history of noncompliance
- Unsuitable for this trial per Investigator's clinical judgment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
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, PR, 00936-5067, Puerto Rico
Puerto Rico Renal Health & Research Center, Inc/ Atlantic Healthcare Group, Inc
Trujillo Alto, PR, 00976, Puerto Rico
Related Publications (2)
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.
PMID: 40576086DERIVEDRodby 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.
PMID: 26239948DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information
- Organization
- Keryx Biopharmaceuticals Inc
Study Officials
- STUDY CHAIR
Julia B Lewis, MD
Collaborative Study Group
- STUDY CHAIR
Samuel Blumenthal, MD
Collaborative Study Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2010
First Posted
August 30, 2010
Study Start
October 1, 2010
Primary Completion
January 1, 2013
Study Completion
February 1, 2013
Last Updated
December 10, 2014
Results First Posted
December 10, 2014
Record last verified: 2014-12