A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis

Completed · Phase 3 · Has a placebo group

Conditions studied: Hyperphosphatemia, Kidney Failure

In brief

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.

Key facts

Study ID

NCT01191255

Run by

Keryx Biopharmaceuticals

People needed

441

Starts

2010-10-01

Expected to finish

2013-02-01

Last updated by the study team

2014-12-10

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
• 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.

Where it is running

• 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
• Southwest Clinical Research Institute, LLC — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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