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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Keryx Biopharmaceuticals
Study ID
NCT01191255
Phase
PHASE3
Status
Completed

Conditions

  • Hyperphosphatemia
  • Kidney Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ferric citrate, ca acetate, sevelamer carbonate, placebo — DRUG
    All intervention doses will be based on serum phosphorus levels and/or drug label requirements

Study Details

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 Dates

Start date
Oct 31, 2010
Status verified
Dec 2014
Primary completion
Jan 31, 2013
Completion
Feb 28, 2013

Study Design

Enrollment
441 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Active Control
    PhosLo (calcium acetate) Renvela (sevelamer carbonate)
  • Placebo Comparator: Placebo
    Placebo
  • Experimental: KRX-0502 (Ferric Citrate)
    ferric citrate

Primary Outcome Measure

Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56) [ Time Frame: 4 weeks ]

Locations (52)

FacilityCityStateZIPSite coordinators
Southwest Clinical Research Institute, LLCTempeArizona85284-
Tower Nephrology Medical GroupLos AngelesCalifornia90048-
Veterans Administration Greater Los Angeles Healthcare System, West Los AngelesLos AngelesCalifornia90073-
Apex Research of RiversideRiversideCalifornia92505-
American Institute of ResearchWhittierCalifornia90603-
University of Colorado DenverAuroraColorado80045-
Western NephrologyWestminsterColorado80031-
PAB Clinical ResearchBrandonFlorida33511-
Mayo ClinicJacksonvilleFlorida32216-
ASA Clinical Research, LLCJupiterFlorida33458-
Ocala Kidney GroupOcalaFlorida34471-
Pines Clinical Research, Inc.Pembroke PinesFlorida33028-
Kidney Care Associates, LLCAugustaGeorgia30901-
Atlanta Nephrology Referral CenterDecaturGeorgia30030-
Circle Medical ManagementChicagoIllinois60607-
Nephrology Specialists, PCMichigan CityIndiana46360-
LSU Health Sciences Center Section of Nephrology and Hypertension Department of Internal MedicineNew OrleansLouisiana70112-
Rockville Dialysis CenterRockvilleMaryland20850-
Tufts Medical CenterBostonMassachusetts02111-
Pioneer Valley NephrologyHolyokeMassachusetts01040-
Western New England Renal & Transplant AssociatesSpringfieldMassachusetts01107-
Henry Ford HospitalDetroitMichigan48202-
Michigan Kidney Consultants, PCPontiacMichigan48341-
Nephrology Hypertension ClinicSouthgateMichigan48195-
Kansas City VA Medical CenterKansas CityMissouri64128-
Brookdale Physician's Dialysis AssociatesBrooklynNew York11212-
Mountain Kidney and Hypertension Associates, PAAshevilleNorth Carolina28801-
Metrolina Nephrology Associates, PACharlotteNorth Carolina28207-
Duke University Medical Center Division of NephrologyDurhamNorth Carolina27705-
Trial Management AssociatesWilmingtonNorth Carolina28401-
Wake Forest University School of MedicineWinston-SalemNorth Carolina27157-
Clinical Research LimitedCantonOhio44718-
Division of Nephrology and Hypertension Department of Internal Medicine University of Cincinnati College of MedicineCincinnatiOhio45267-
Cleveland Clinic Foundation Q7-150 NephrologyClevelandOhio44195-
The Ohio State University Division of NephrologyColumbusOhio43210-
DaVitaOklahoma CityOklahoma73116-
University of Pennsylvania Health SystemPhiladelphiaPennsylvania19104-
Southeast Renal Research Institute Nephrology AssociatesChattanoogaTennessee37404-
Nephrology Associates, PCNashvilleTennessee37205-
Vanderbilt University Medical Center Clinical Trials CenterNashvilleTennessee37232-1371-
UT Southwestern Medical Center at DallasDallasTexas75390-
Kidney AssociatesHoustonTexas77030-
Nephrology, PAHoustonTexas77030-
Kidney Specialists of North Houston, PLLCThe WoodlandsTexas77384-
University of Utah Health Sciences CenterSalt Lake CityUtah84132-
University of Vermont/ Fletcher Allen Health Care; Renal ServicesBurlingtonVermont05401-
Nephrology Clinical Research CenterCharlottesvilleVirginia22908-
Clinical Research & Consulting Center, LLCFairfaxVirginia22030-
Nephrology Associates of Northern Virginia, Inc.FairfaxVirginia22033-
Peninsula Kidney AssociatesHamptonVirginia23666-
McGuire VA Medical CenterRichmondVirginia23249-
Medical College of Wisconsin Froedert Memorial Lutheran Hospital Division of NephrologyMilwaukeeWisconsin53226-

Find similar trials in Tempe, AZ

By research site
Southwest Clinical Research Institute, LLC· Tempe, AZTower Nephrology Medical Group· Los Angeles, CAVeterans Administration Greater Los Angeles Healthcare System, West Los Angeles· Los Angeles, CAApex Research of Riverside· Riverside, CAAmerican Institute of Research· Whittier, CAUniversity of Colorado Denver· Aurora, CO

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