Clinical trial NCT01191255: A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
Official title: A Three-Period, 58-Week Safety and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) on Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperphosphatemia
Kidney Failure
Keywords: ESRD
end-stage renal disease
dialysis
hemodialysis
peritoneal dialysis
hemodialysis (HD)
peritoneal dialysis (PD)
chronic renal insufficiency
phosphate binder
kidney failure
renal failure
Lead sponsor: Keryx Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-08-30
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Males or non-pregnant, non-breast-feeding females
2. Age ≥18 years
3. On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening
4. Serum phosphorus ≥6.0 mg/dL for study entry
5. Taking less than 3-18 pills/day of current phosphate binder
6. Willing to be discontinued from current phosphate binder(s) and initiated on ferric citrate
7. Willing and able to give informed consent
8. Life expectancy \>1 year

Exclusion Criteria:

1. Parathyroidectomy within six months prior to Screening
2. Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
3. History of multiple drug allergies or intolerances
4. History of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by CCC)
5. Previous intolerance to oral ferric citrate
6. Intolerance to oral iron-containing products
7. Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
8. Inability to tolerate oral drug intake
9. Intolerance to calcium acetate and sevelamer carbonate
10. 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
11. Receipt of any investigational drug within 30 days of Screening Visit (Visit 0)
12. Inability to cooperate with study personnel or history of noncompliance
13. Unsuitable for this trial per Investigator's clinical judgment.

Primary outcomes:
measure: Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56)
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Mean Serum Ferritin From Baseline to Week 52
timeFrame: 52 weeks
measure: Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52)
timeFrame: 52 weeks
measure: IV Iron Analysis
timeFrame: 52 weeks
measure: ESA Analysis
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Southwest Clinical Research Institute, LLC
state: Arizona
city: Los Angeles
country: United States
facility: Tower Nephrology Medical Group
state: California
city: Los Angeles
country: United States
facility: Veterans Administration Greater Los Angeles Healthcare System, West Los Angeles
state: California
city: Riverside
country: United States
facility: Apex Research of Riverside
state: California
city: Whittier
country: United States
facility: American Institute of Research
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Westminster
country: United States
facility: Western Nephrology
state: Colorado
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Jupiter
country: United States
facility: ASA Clinical Research, LLC
state: Florida
city: Ocala
country: United States
facility: Ocala Kidney Group
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Clinical Research, Inc.
state: Florida
city: Augusta
country: United States
facility: Kidney Care Associates, LLC
state: Georgia
city: Decatur
country: United States
facility: Atlanta Nephrology Referral Center
state: Georgia
city: Chicago
country: United States
facility: Circle Medical Management
state: Illinois
city: Michigan City
country: United States
facility: Nephrology Specialists, PC
state: Indiana
city: New Orleans
country: United States
facility: LSU Health Sciences Center Section of Nephrology and Hypertension Department of Internal Medicine
state: Louisiana
city: Rockville
country: United States
facility: Rockville Dialysis Center
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Holyoke
country: United States
facility: Pioneer Valley Nephrology
state: Massachusetts
city: Springfield
country: United States
facility: Western New England Renal & Transplant Associates
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Pontiac
country: United States
facility: Michigan Kidney Consultants, PC
state: Michigan
city: Southgate
country: United States
facility: Nephrology Hypertension Clinic
state: Michigan
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
city: Brooklyn
country: United States
facility: Brookdale Physician's Dialysis Associates
state: New York
city: Asheville
country: United States
facility: Mountain Kidney and Hypertension Associates, PA
state: North Carolina
city: Charlotte
country: United States
facility: Metrolina Nephrology Associates, PA
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center Division of Nephrology
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates
state: North Carolina
city: Winston Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Canton
country: United States
facility: Clinical Research Limited
state: Ohio
city: Cincinnati
country: United States
facility: Division of Nephrology and Hypertension Department of Internal Medicine University of Cincinnati College of Medicine
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation Q7-150 Nephrology
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Division of Nephrology
state: Ohio
city: Oklahoma City
country: United States
facility: DaVita
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Chattanooga
country: United States
facility: Southeast Renal Research Institute Nephrology Associates
state: Tennessee
city: Nashville
country: United States
facility: Nephrology Associates, PC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center Clinical Trials Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: Kidney Associates
state: Texas
city: Houston
country: United States
facility: Nephrology, PA
state: Texas
city: The Woodlands
country: United States
facility: Kidney Specialists of North Houston, PLLC
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Burlington
country: United States
facility: University of Vermont/ Fletcher Allen Health Care; Renal Services
state: Vermont
city: Charlottesville
country: United States
facility: Nephrology Clinical Research Center
state: Virginia
city: Fairfax
country: United States
facility: Clinical Research & Consulting Center, LLC
state: Virginia
city: Fairfax
country: United States
facility: Nephrology Associates of Northern Virginia, Inc.
state: Virginia
city: Hampton
country: United States
facility: Peninsula Kidney Associates
state: Virginia
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Froedert Memorial Lutheran Hospital Division of Nephrology
state: Wisconsin
city: Ashkelon
country: Israel
facility: Department of Nephrology and Hypertension Brazilai Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center Nephrology Department
city: Rio Piedras
country: Puerto Rico
facility: RCMI-Clinical Research Center Medical Sciences Campus University of Puerto Rico
city: Trujillo Alto
country: Puerto Rico
facility: Puerto Rico Renal Health & Research Center, Inc/ Atlantic Healthcare Group, Inc
Study officials:
affiliation: Collaborative Study Group
name: Julia B Lewis, MD
role: STUDY_CHAIR
affiliation: Collaborative Study Group
name: Samuel Blumenthal, MD
role: STUDY_CHAIR
References:
citation: Rodby RA, Umanath K, Niecestro R, Bond TC, Sika M, Lewis J, Dwyer JP; Collaborative Study Group. Ferric Citrate, an Iron-Based Phosphate Binder, Reduces Health Care Costs in Patients on Dialysis Based on Randomized Clinical Trial Data. Drugs R D. 2015 Sep;15(3):271-9. doi: 10.1007/s40268-015-0103-y.