A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis
1 other identifier
interventional
168
2 countries
34
Brief Summary
A long-term safety study of ferric citrate (KRX-0502) in renal failure patients who have completed study KRX-0502-304. Only patients who participated in the KRX-0502-304 trial may participate in this trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2012
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2012
CompletedFirst Posted
Study publicly available on registry
March 15, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
July 13, 2016
CompletedJuly 13, 2016
June 1, 2016
1.8 years
March 12, 2012
September 24, 2015
June 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Serum Phosphorus- Baseline
Baseline
Serum Phosphorus- Week 48
48 weeks
Ferritin- Baseline
Baseline
- +6 more other outcomes
Study Arms (1)
Ferric Citrate
OTHEROpen label extension of those completing study KRX-0304
Interventions
Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Eligibility Criteria
You may qualify if:
- Males or non-pregnant, non-breast-feeding females who participated in the Safety Assessment Period (SAP), and if eligible, the Efficacy Assessment Period (EAP) of Study KRX-0502-304
- Willing and able to give informed consent
You may not qualify if:
- Subjects on KRX-0502 (ferric citrate) in KRX-0502-304 who were treatment failures in first period
- Any subject in Study KRX-0502-304 SAP who early terminated from the trial
- Any subject who participated in Study KRX-0502-304 but declined EAP
- Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
- History of malignancy in the last five years
- Previous intolerance to KRX-0502 (ferric citrate)
- Intolerance to oral iron-containing products
- Absolute requirement for oral iron therapy
- Absolute requirement for Vitamin C (multivitamins \[Nephrocaps, Renaphro, etc.\] allowed)
- Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
- Inability to tolerate oral drug intake
- 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
- Inability to cooperate with study personnel or history of noncompliance
- Unsuitable for this trial per Principal Investigator's (PI) clinical judgment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
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, PR, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lisa Loram
- Organization
- Keryx
Study Officials
- STUDY CHAIR
Julia B Lewis, MD
Collaborative Study Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2012
First Posted
March 15, 2012
Study Start
August 1, 2012
Primary Completion
June 1, 2014
Study Completion
August 1, 2014
Last Updated
July 13, 2016
Results First Posted
July 13, 2016
Record last verified: 2016-06