A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
- Conditions
- Kidney FailureHyperphosphatemia
- Interventions
- Drug: ferric citrate, ca acetate, sevelamer carbonate, placebo
- Registration Number
- NCT01191255
- Lead Sponsor
- Keryx Biopharmaceuticals
- 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 Safety Assessment Period, and the third period is a four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period in only the patients who were randomized to treatment with ferric citrate during the Safety Assessment Period. The primary objectives of this trial are to determine the long-term safety over 52 weeks of up to twelve (12) caplets/day of KRX-0502 (ferric citrate) in patients with ESRD undergoing either hemodialysis or peritoneal dialysis and to determine the efficacy of KRX-0502 (ferric citrate) in the four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 441
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Active Control ferric citrate, ca acetate, sevelamer carbonate, placebo PhosLo (calcium acetate) Renvela (sevelamer carbonate) Placebo ferric citrate, ca acetate, sevelamer carbonate, placebo Placebo KRX-0502 (Ferric Citrate) ferric citrate, ca acetate, sevelamer carbonate, placebo ferric citrate
- Primary Outcome Measures
Name Time Method Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56) 4 weeks 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.
- Secondary Outcome Measures
Name Time Method 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 Full Analysis Population, cumulative IV Iron administration from Baseline to the end of the Safety Assessment Period (Week 52)
ESA Analysis 52 weeks Full analysis population, cumulative Erythropoiesis-stimulating agent (ESA) administration from baseline to the end of the Safety Assessment Period (Week 52)
Trial Locations
- Locations (56)
Circle Medical Management
🇺🇸Chicago, Illinois, United States
Cleveland Clinic Foundation Q7-150 Nephrology
🇺🇸Cleveland, Ohio, United States
Nephrology, PA
🇺🇸Houston, Texas, United States
Veterans Administration Greater Los Angeles Healthcare System, West Los Angeles
🇺🇸Los Angeles, California, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
Western Nephrology
🇺🇸Westminster, Colorado, United States
Apex Research of Riverside
🇺🇸Riverside, California, United States
Nephrology Hypertension Clinic
🇺🇸Southgate, Michigan, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Brookdale Physician's Dialysis Associates
🇺🇸Brooklyn, New York, United States
Southeast Renal Research Institute Nephrology Associates
🇺🇸Chattanooga, Tennessee, United States
The Ohio State University Division of Nephrology
🇺🇸Columbus, Ohio, United States
Nephrology Clinical Research Center
🇺🇸Charlottesville, Virginia, United States
Clinical Research & Consulting Center, LLC
🇺🇸Fairfax, Virginia, United States
Peninsula Kidney Associates
🇺🇸Hampton, Virginia, United States
Puerto Rico Renal Health & Research Center, Inc/ Atlantic Healthcare Group, Inc
🇵🇷Trujillo Alto, Puerto Rico
DaVita
🇺🇸Oklahoma City, Oklahoma, United States
Nephrology Associates, PC
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center Clinical Trials Center
🇺🇸Nashville, Tennessee, United States
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Medical College of Wisconsin Froedert Memorial Lutheran Hospital Division of Nephrology
🇺🇸Milwaukee, Wisconsin, United States
Southwest Clinical Research Institute, LLC
🇺🇸Tempe, Arizona, United States
Clinical Research Limited
🇺🇸Canton, Ohio, United States
Wake Forest University School of Medicine
🇺🇸Winston Salem, North Carolina, United States
Tower Nephrology Medical Group
🇺🇸Los Angeles, California, United States
Kidney Care Associates, LLC
🇺🇸Augusta, Georgia, 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
American Institute of Research
🇺🇸Whittier, California, United States
Rockville Dialysis Center
🇺🇸Rockville, Maryland, United States
Western New England Renal & Transplant Associates
🇺🇸Springfield, Massachusetts, United States
Mountain Kidney and Hypertension Associates, PA
🇺🇸Asheville, North Carolina, United States
Duke University Medical Center Division of Nephrology
🇺🇸Durham, North Carolina, United States
Trial Management Associates
🇺🇸Wilmington, North Carolina, United States
UT Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
Kidney Specialists of North Houston, PLLC
🇺🇸The Woodlands, Texas, United States
Nephrology Associates of Northern Virginia, Inc.
🇺🇸Fairfax, Virginia, United States
Kidney Associates
🇺🇸Houston, Texas, United States
Tel Aviv Sourasky Medical Center Nephrology Department
🇮🇱Tel Aviv, Israel
RCMI-Clinical Research Center Medical Sciences Campus University of Puerto Rico
🇵🇷Rio Piedras, Puerto Rico
ASA Clinical Research, LLC
🇺🇸Jupiter, Florida, United States
Ocala Kidney Group
🇺🇸Ocala, Florida, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Atlanta Nephrology Referral Center
🇺🇸Decatur, Georgia, United States
Pines Clinical Research, Inc.
🇺🇸Pembroke Pines, Florida, United States
Pioneer Valley Nephrology
🇺🇸Holyoke, Massachusetts, United States
Division of Nephrology and Hypertension Department of Internal Medicine University of Cincinnati College of Medicine
🇺🇸Cincinnati, Ohio, United States
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
Metrolina Nephrology Associates, PA
🇺🇸Charlotte, North Carolina, United States
Michigan Kidney Consultants, PC
🇺🇸Pontiac, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Department of Nephrology and Hypertension Brazilai Medical Center
🇮🇱Ashkelon, Israel
University of Vermont/ Fletcher Allen Health Care; Renal Services
🇺🇸Burlington, Vermont, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
Kansas City VA Medical Center
🇺🇸Kansas City, Missouri, United States