Clinical trial NCT00567723: Long Term Treatment of End Stage Renal Disease Patients With Lanthanum Carbonate (Fosrenol)
Official title: A Phase-IV, Long-term, Observational Safety Study in End Stage Renal Disease Subjects Treated With Lanthanum Carbonate (Fosrenol)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperphosphatemia
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 2105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients for the Historical Control and Concomitant Therapy Groups will be selected from the United States Renal Data System (USRDS). The Test Group will consist of patients who have had a minimum of 12 consecutive weeks of exposure to Fosrenol (lanthanum carbonate).

Brief summary: Patients who have been treated with Fosrenol for a minimum of 12 consecutive weeks and are receiving dialysis will be followed for 5 years to compare mortality, bone fractures and incidence of selected morbidities to patients with no lanthanum exposure and to patients being treated for hyperphosphatemia with any marketed product.


Eligibility criteria: Inclusion Criteria: Test Group

* Signed informed consent
* Patient must have ESRD and be receiving dialysis
* Prior treatment with Fosrenol for a minimum of 12 consecutive weeks
* Primary payer of healthcare must be Medicare (patient must supply Medicare Claim Number)
* Patient must be 18 years of age or older

Exclusion Criteria: Test Group

* Patients that do not meet inclusion criteria

Primary outcomes:
measure: Compare all-cause mortality and bone fractures among three groups of subjects with end stage renal disease (ESRD)
timeFrame: 5 years
Secondary outcomes:
measure: Compare the incidence of selected morbidities among three groups of patients with ESRD
timeFrame: 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center, Inc.
state: Alabama
city: Hoover
country: United States
facility: Clinical Research Consultants
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Montgomery
country: United States
facility: Montgomery Kidney Specialists
state: Alabama
city: Covina
country: United States
facility: California Kidney Specialist
state: California
city: Cudahy
country: United States
facility: Atlantic Avenue Medical Clinic
state: California
city: Hayward
country: United States
facility: East Bay-South Hayward Dialysis Center
state: California
city: Los Alamitos
country: United States
facility: Renal Research Center
state: California
city: Los Angeles
country: United States
facility: USC Kidney Center
state: California
city: Los Angeles
country: United States
facility: Beverly Nephrology
state: California
city: Los Angeles
country: United States
facility: Tower Nephrology Medical Group
state: California
city: Los Angeles
country: United States
facility: USC DaVita Dialysis Center
state: California
city: Lynwood
country: United States
facility: Renal Medical Associates
state: California
city: Northridge
country: United States
facility: Valley Renal Medical Group
state: California
city: Palm Springs
country: United States
facility: Desert Nephrolgy Medical Group
state: California
city: Palo Alto
country: United States
facility: Palo Alto Nephrology
state: California
city: Pasadena
country: United States
facility: Pasadena Nephrology
state: California
city: Sacramento
country: United States
facility: Capital Nephrology
state: California
city: San Bernardino
country: United States
facility: Citrus Valley Dialysis Center
state: California
city: San Dimas
country: United States
facility: California Kidney Specialist
state: California
city: San Francisco
country: United States
facility: San Francisco Dialysis Center # 3830
state: California
city: San Jose
country: United States
facility: Habib A. Tobbagi, MD
state: California
city: Selma
country: United States
facility: Selma DaVita Dialysis
state: California
city: Ukiah
country: United States
facility: Pear Tree Dialysis
state: California
city: Victorville
country: United States
facility: High Desert Nephrology
state: California
city: Visalia
country: United States
facility: Renal Medical Group
state: California
city: Yuba City
country: United States
facility: North Valley Nephrology
state: California
city: Hartford
country: United States
facility: Hartford North
state: Connecticut
city: New Haven
country: United States
facility: Metabolism Associates
state: Connecticut
city: Torrington
country: United States
facility: Torrington Dialysis
state: Connecticut
city: Washington
country: United States
facility: Davita-Brentwood
state: District of Columbia
city: Washington
country: United States
facility: Lee Street Dialysis
state: District of Columbia
city: Washington
country: United States
facility: Union Plaza Dialysis Center
state: District of Columbia
city: Brandon
country: United States
facility: PAB Clinical Resesarch
state: Florida
city: Coral Springs
country: United States
facility: South Florida Nephrology Group
state: Florida
city: Daytona Beach
country: United States
facility: Nephrology Consultants, PA
state: Florida
city: Fort Myers
country: United States
facility: DaVita Fort Myers
state: Florida
city: Fort Pierce
country: United States
facility: Nephrology Associates
state: Florida
city: Hudson
country: United States
facility: Outcomes Research International, Inc
state: Florida
city: Lakeland
country: United States
facility: Central Florida Kidney Care, PA
state: Florida
city: Miami
country: United States
facility: Miami Kidney Group
state: Florida
city: Miami
country: United States
facility: Nephrology Associates of South Miami
state: Florida
city: Orlando
country: United States
facility: Nephrology Associates of Central Florida
state: Florida
city: Panama City
country: United States
facility: Nephrology Associates Research Center
state: Florida
city: Pembroke Pines
country: United States
facility: A Unique Kidney Center, LLC
state: Florida
city: Pinecrest
country: United States
facility: PharmResearch, Inc.
state: Florida
city: Tampa
country: United States
facility: Tampa Bay Nephrology Associates
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research
state: Florida
city: Athens
country: United States
facility: North Georgia Nephrology Consultant
state: Georgia
city: Atlanta
country: United States
facility: Southwest Atlanta Nephrology, PC
state: Georgia
city: Atlanta
country: United States
facility: North Atlantic Kidney Specialist
state: Georgia
city: Atlanta
country: United States
facility: AtlantaDavita East
state: Georgia
city: Atlanta
country: United States
facility: Davita South Fulton
state: Georgia
city: Augusta
country: United States
facility: Kidney Care Associates, LLC
state: Georgia
city: Douglas
country: United States
facility: Douglas Dialysis
state: Georgia
city: Dublin
country: United States
facility: Renal Physicians of Georgia
state: Georgia
city: Macon
country: United States
facility: Renal Physicians of Georgia
state: Georgia
city: Savannah
country: United States
facility: Williams Street Dialysis
state: Georgia
city: Waycross
country: United States
facility: Waycross Dialysis Facility
state: Georgia
city: Waycross
country: United States
facility: Waycross Dialysis Facility
state: Georgia
city: Boise
country: United States
facility: Table Rock Dialysis
state: Idaho
city: Nampa
country: United States
facility: Nampa DaVita Dialysis
state: Idaho
city: Aurora
country: United States
facility: Fox Valley Dialysis
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Des Plaines
country: United States
facility: Associates in Nephrology
state: Illinois
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare
state: Illinois
city: Evergreen Park
country: United States
facility: Associates in Nephrology
state: Illinois
city: Gurnee
country: United States
facility: North Suburban Nephrology, LLC
state: Illinois
city: Libertyville
country: United States
facility: Lake County
state: Illinois
city: Park Ridge
country: United States
facility: Nephrology & Hypertension Consultants, PC
state: Illinois
city: Peoria
country: United States
facility: Renal Care Associates
state: Illinois
city: Sauget
country: United States
facility: Sauget Dialysis
state: Illinois
city: Evansville
country: United States
facility: Nephrology Associates, LLC
state: Indiana
city: Gary
country: United States
facility: Nephrology Specialists PC
state: Indiana
city: Lawrenceburg
country: United States
facility: Lawrenceburg Dialysis Center
state: Indiana
city: Michigan City
country: United States
facility: Nephrology Specialists
state: Indiana
city: Muncie
country: United States
facility: Renal Associates of Central Indiana
state: Indiana
city: Muncie
country: United States
facility: Renal Associates of Central Indiana
state: Indiana
city: Muncie
country: United States
facility: Ball Memorial Hospital
state: Indiana
city: Fort Dodge
country: United States
facility: TriMark Physicians Group
state: Iowa
city: Olathe
country: United States
facility: Olathe DaVita
state: Kansas
city: Overland Park
country: United States
facility: DaVita-Johnson County Dialysis
state: Kansas
city: Topeka
country: United States
facility: Veritas Clinical Specialists, Ltd
state: Kansas
city: Topeka
country: United States
facility: Dennis Artzer
state: Kansas
city: Baton Rouge
country: United States
facility: Renal Associates of Baton Rouge
state: Louisiana
city: Marrero
country: United States
facility: West Bank Nephrology
state: Louisiana
city: New Orleans
country: United States
facility: LSU Healthcare Network
state: Louisiana
city: New Orleans
country: United States
facility: Westbank Chronic Renal Center
state: Louisiana
city: Shreveport
country: United States
facility: Northwest Louisiana Nephrology, LLC
state: Louisiana
city: Baltimore
country: United States
facility: DaVita JHHS Bond Street
state: Maryland
city: Clinton
country: United States
facility: Nephrology and Hypertension
state: Maryland
city: Frederick
country: United States
facility: DaVita Frederick Dialysis #3373
state: Maryland
city: Glen Burnie
country: United States
facility: Glen Burnie Dialysis Center
state: Maryland
city: Greenbelt
country: United States
facility: Promod K. Duggal, MD, PC
state: Maryland
city: Oxon Hill
country: United States
facility: Rivertowne Davita Dialysis
state: Maryland
city: Rockville
country: United States
facility: Biolab Research, LLC
state: Maryland
city: Upper Marlboro
country: United States
facility: Davita of Landover
state: Maryland
city: Westminster
country: United States
facility: Carroll County Dialysis Facility
state: Maryland
city: Fall River
country: United States
facility: Horowitz and Krahn
state: Massachusetts
city: Springfield
country: United States
facility: Western New England Renal Transplant Association
state: Massachusetts
city: Alma
country: United States
facility: Great Lakes Renal Network
state: Michigan
city: Grand Rapids
country: United States
facility: PDI Grand Rapids East
state: Michigan
city: Lansing
country: United States
facility: Mid Michigan Kidney Specialists
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Warren
country: United States
facility: Macomb Kidney Center
state: Michigan
city: Columbia
country: United States
facility: Health Sciences Center
state: Missouri
city: Saint Louis
country: United States
facility: Douglas T. Domoto MD, JD, PC
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University Department of Internal Medicine
state: Missouri
city: Eatontown
country: United States
facility: Hypertension & Nephrology Associates, PA
state: New Jersey
city: Edison
country: United States
facility: DaVita Edison
state: New Jersey
city: Mount Laurel
country: United States
facility: Center for Kidney Care
state: New Jersey
city: Vineland
country: United States
facility: Cumberland Nephrology Associates, PA
state: New Jersey
city: Brooklyn
country: United States
facility: Kidney Care Associates, PLLC
state: New York
city: Brooklyn
country: United States
facility: Angelo Magno, MD
state: New York
city: Brooklyn
country: United States
facility: Brookdale Physicians Dialysis associates, P.C.
state: New York
city: Carmel
country: United States
facility: Celia Dill Dialysis Center
state: New York
city: Elmira
country: United States
facility: AMS Research
state: New York
city: Flushing
country: United States
facility: Nephrology Associates, PC
state: New York
city: Great Neck
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Lower Manhattan Dialysis Center
state: New York
city: New York
country: United States
facility: Bronx Dialysis center
state: New York
city: Rochester
country: United States
facility: Nephrology Associates
state: New York
city: Rochester
country: United States
facility: University of Rochester Nephrology Unit
state: New York
city: Rockville Centre
country: United States
facility: Island Renal Associates, PC
state: New York
city: Springfield Gardens
country: United States
facility: Clinical Research Development Association, LLC
state: New York
city: Stony Brook
country: United States
facility: SUNY at Stony Brook NY
state: New York
city: Syosset
country: United States
facility: Syosset Kidney Center
state: New York
city: Yonkers
country: United States
facility: Yonkers Nephrology, PC
state: New York
city: Asheville
country: United States
facility: Mountain Kidney
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina Division of Nephrology & Hypertension
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Dialysis
state: North Carolina
city: Elizabeth City
country: United States
facility: Albemarle Nephrology Associates
state: North Carolina
city: Hamlet
country: United States
facility: Dialysis Care of Richmond County
state: North Carolina
city: Raeford
country: United States
facility: Dialysis Care of Hoke County
state: North Carolina
city: Reidsville
country: United States
facility: Reidsville Dialysis
state: North Carolina
city: Wilmington
country: United States
facility: Southeastern Nephrology Associates
state: North Carolina
city: Wilson
country: United States
facility: DaVita Wilson Dialysis #3032
state: North Carolina
city: Winston-Salem
country: United States
facility: Nephrology Associates, PLLC
state: North Carolina
city: Grand Forks
country: United States
facility: Altru Health System Research Center
state: North Dakota
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Toledo
country: United States
facility: Nephrology Consultants of Northwest Ohio
state: Ohio
city: Youngstown
country: United States
facility: Saint Elizabeth Healthcare Department of Research
state: Ohio
city: Youngstown
country: United States
facility: NAI fo Kidney Care
state: Ohio
city: Camp Hill
country: United States
facility: Nephrology Assciates of Central PA, INC
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Erie
country: United States
facility: Renal Care of Erie
state: Pennsylvania
city: Exton
country: United States
facility: Exton Dialysis Center
state: Pennsylvania
city: Lancaster
country: United States
facility: Davita Lancaster
state: Pennsylvania
city: Lewistown
country: United States
facility: Lewistown Dialysis Center
state: Pennsylvania
city: Mohnton
country: United States
facility: Reading Nephrology, Ltd.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennyslvania Nephrology Associates, PC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Davita West Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Franklin Dialysis Center
state: Pennsylvania
city: Pottsville
country: United States
facility: Syed Shah
state: Pennsylvania
city: Saint Clair
country: United States
facility: Syed Shah
state: Pennsylvania
city: Washington
country: United States
facility: Washington Dialysis
state: Pennsylvania
city: Wellsboro
country: United States
facility: Dialyis Corporation of America
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Nephrology, Ltd.
state: Pennsylvania
city: Wyomissing
country: United States
facility: Reading Nephrology, Ltd
state: Pennsylvania
city: Anderson
country: United States
facility: Nephrology and Internal Medicine
state: South Carolina
city: Greenville
country: United States
facility: Carolina Nephrology, PA
state: South Carolina
city: Kingstree
country: United States
facility: Internal Medicine Nephrology/Hypertension
state: South Carolina
city: North Charleston
country: United States
facility: Charleston Nephrology Associates
state: South Carolina
city: Southern Pines
country: United States
facility: Southern Pines Dialysis
state: South Carolina
city: Knoxville
country: United States
facility: Newman
state: Tennessee
city: Knoxville
country: United States
facility: G. Edward Newman, MD, PLLC
state: Tennessee
city: Maynardville
country: United States
facility: Internal Medicina and Nephrology
state: Tennessee
city: Memphis
country: United States
facility: Memphis Central DaVita
state: Tennessee
city: Nashville
country: United States
facility: VA Tennessee Valley, Health Care System
state: Tennessee
city: Arlington
country: United States
facility: Arlington Nephrology, PA
state: Texas
city: Brenham
country: United States
facility: Brenham
state: Texas
city: El Paso
country: United States
facility: Kidney Consultants fo El Paso, P.A.
state: Texas
city: Houston
country: United States
facility: Med-Center Dialysis
state: Texas
city: Houston
country: United States
facility: Innovative Renal Care
state: Texas
city: Houston
country: United States
facility: Med-Center Dialysis
state: Texas
city: Houston
country: United States
facility: Northwest Kidney Center
state: Texas
city: Houston
country: United States
facility: Greater Houston Kidney Specialist
state: Texas
city: Houston
country: United States
facility: Kidney Associates, PLLC
state: Texas
city: Houston
country: United States
facility: Northwest Kidney Center
state: Texas
city: Houston
country: United States
facility: DaVita Northstar Dialysis
state: Texas
city: Wichita Falls
country: United States
facility: Patel
state: Texas
city: Bountiful
country: United States
facility: Pharmaceutical Research Organization
state: Utah
city: Ogden
country: United States
facility: Nephrology of Northern Utah
state: Utah
city: Provo
country: United States
facility: Central Utah Clinic
state: Utah
city: Burlington
country: United States
facility: University of Vermont, Fletcher Allen Health Care
state: Vermont
city: Charlottesville
country: United States
facility: Jefferson Nephrology Ltd
state: Virginia
city: Chesapeake
country: United States
facility: Great Bridge Dialysis Center
state: Virginia
city: Fairfax
country: United States
facility: Nephrology Associates of Northern Virgina
state: Virginia
city: Martinsville
country: United States
facility: Piedmont Medical and Renal Associates
state: Virginia
city: Newport News
country: United States
facility: Peninsula Dialysis
state: Virginia
city: Portsmouth
country: United States
facility: Davita-Greater Portsmouth
state: Virginia
city: Portsmouth
country: United States
facility: Portsmouth Dialysis Center-DaVita
state: Virginia
city: Richmond
country: United States
facility: Nephrology Specialists, PC
state: Virginia
city: Lakewood
country: United States
facility: Lakewood Community Dialysis Center
state: Washington
city: Appleton
country: United States
facility: Fox Valley Nephrology Partners, SC
state: Wisconsin
city: Delafield
country: United States
facility: Purity Dialysis Centers
state: Wisconsin
city: La Crosse
country: United States
facility: Gundersen Lutheran, Ltd
state: Wisconsin
city: Oshkosh
country: United States
facility: Fox Valley Nephrology Partners, PC
state: Wisconsin
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Hutchison A, Whelton A, Thadhani R, Achenbach H, Vergani A, Wu J, Hall G. Long-Term Mortality and Bone Safety in Patients with End-Stage Renal Disease Receiving Lanthanum Carbonate. Nephron. 2018;140(4):265-274. doi: 10.1159/000492603. Epub 2018 Oct 23.
citation: Hutchison AJ, Wilson RJ, Garafola S, Copley JB. Lanthanum carbonate: safety data after 10 years. Nephrology (Carlton). 2016 Dec;21(12):987-994. doi: 10.1111/nep.12864.