A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis

Completed · Phase 3

Conditions studied: End Stage Renal Disease, Kidney Failure, Renal Failure, Hyperphosphatemia, ESRD

In brief

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.

Key facts

Study ID

NCT01554982

Run by

Keryx Biopharmaceuticals

People needed

168

Starts

2012-08-01

Expected to finish

2014-08-01

Last updated by the study team

2016-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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