Status:
COMPLETED
A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
Lead Sponsor:
Keryx Biopharmaceuticals
Conditions:
Hyperphosphatemia
Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Detailed Description
This trial is a three-period, multicenter, safety and efficacy clinical trial. The first period is a two-week Washout Period, the second period is a 52-week randomized, open-label, active control Safe...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
441 Patients enrolled
Trial Details
Trial ID
NCT01191255
Start Date
October 1 2010
End Date
February 1 2013
Last Update
December 10 2014
Active Locations (56)
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1
Southwest Clinical Research Institute, LLC
Tempe, Arizona, United States, 85284
2
Tower Nephrology Medical Group
Los Angeles, California, United States, 90048
3
Veterans Administration Greater Los Angeles Healthcare System, West Los Angeles
Los Angeles, California, United States, 90073
4
Apex Research of Riverside
Riverside, California, United States, 92505