Long Term Treatment of End Stage Renal Disease Patients With Lanthanum Carbonate (Fosrenol)
- Conditions
- Hyperphosphatemia
- Registration Number
- NCT00567723
- Lead Sponsor
- Shire
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2105
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
Test Group
- Patients that do not meet inclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare all-cause mortality and bone fractures among three groups of subjects with end stage renal disease (ESRD) 5 years
- Secondary Outcome Measures
Name Time Method Compare the incidence of selected morbidities among three groups of patients with ESRD 5 years
Trial Locations
- Locations (189)
Portsmouth Dialysis Center-DaVita
🇺🇸Portsmouth, Virginia, United States
Davita South Fulton
🇺🇸Atlanta, Georgia, United States
DaVita JHHS Bond Street
🇺🇸Baltimore, Maryland, United States
Biolab Research, LLC
🇺🇸Rockville, Maryland, United States
Carroll County Dialysis Facility
🇺🇸Westminster, Maryland, United States
Northwest Louisiana Nephrology, LLC
🇺🇸Shreveport, Louisiana, United States
Horowitz and Krahn
🇺🇸Fall River, Massachusetts, United States
Nephrology of Northern Utah
🇺🇸Ogden, Utah, United States
DaVita Edison
🇺🇸Edison, New Jersey, United States
Carolina Nephrology, PA
🇺🇸Greenville, South Carolina, United States
Internal Medicine Nephrology/Hypertension
🇺🇸Kingstree, South Carolina, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Mid Michigan Kidney Specialists
🇺🇸Lansing, Michigan, United States
Nephrology and Hypertension
🇺🇸Clinton, Maryland, United States
Cumberland Nephrology Associates, PA
🇺🇸Vineland, New Jersey, United States
Davita of Landover
🇺🇸Upper Marlboro, Maryland, United States
Memphis Central DaVita
🇺🇸Memphis, Tennessee, United States
PDI Grand Rapids East
🇺🇸Grand Rapids, Michigan, United States
North Shore University Hospital
🇺🇸Great Neck, New York, United States
Center for Kidney Care
🇺🇸Mount Laurel, New Jersey, United States
Macomb Kidney Center
🇺🇸Warren, Michigan, United States
Hypertension & Nephrology Associates, PA
🇺🇸Eatontown, New Jersey, United States
Charleston Nephrology Associates
🇺🇸North Charleston, South Carolina, United States
Newman
🇺🇸Knoxville, Tennessee, United States
G. Edward Newman, MD, PLLC
🇺🇸Knoxville, Tennessee, United States
Southern Pines Dialysis
🇺🇸Southern Pines, South Carolina, United States
Internal Medicina and Nephrology
🇺🇸Maynardville, Tennessee, United States
Renal Research Center
🇺🇸Los Alamitos, California, United States
Valley Renal Medical Group
🇺🇸Northridge, California, United States
Atlantic Avenue Medical Clinic
🇺🇸Cudahy, California, United States
USC Kidney Center
🇺🇸Los Angeles, California, United States
Tower Nephrology Medical Group
🇺🇸Los Angeles, California, United States
Selma DaVita Dialysis
🇺🇸Selma, California, United States
Clinical Research Consultants
🇺🇸Hoover, Alabama, United States
Montgomery Kidney Specialists
🇺🇸Montgomery, Alabama, United States
California Kidney Specialist
🇺🇸San Dimas, California, United States
East Bay-South Hayward Dialysis Center
🇺🇸Hayward, California, United States
University of South Alabama
🇺🇸Mobile, Alabama, United States
Beverly Nephrology
🇺🇸Los Angeles, California, United States
Sauget Dialysis
🇺🇸Sauget, Illinois, United States
USC DaVita Dialysis Center
🇺🇸Los Angeles, California, United States
Nephrology Specialists PC
🇺🇸Gary, Indiana, United States
Nephrology & Hypertension Consultants, PC
🇺🇸Park Ridge, Illinois, United States
Lake County
🇺🇸Libertyville, Illinois, United States
Evanston Northwestern Healthcare
🇺🇸Evanston, Illinois, United States
Nephrology Associates, LLC
🇺🇸Evansville, Indiana, United States
Glen Burnie Dialysis Center
🇺🇸Glen Burnie, Maryland, United States
Renal Care Associates
🇺🇸Peoria, Illinois, United States
North Suburban Nephrology, LLC
🇺🇸Gurnee, Illinois, United States
Rivertowne Davita Dialysis
🇺🇸Oxon Hill, Maryland, United States
Nephrology Specialists
🇺🇸Michigan City, Indiana, United States
West Bank Nephrology
🇺🇸Marrero, Louisiana, United States
Renal Associates of Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Western New England Renal Transplant Association
🇺🇸Springfield, Massachusetts, United States
Great Lakes Renal Network
🇺🇸Alma, Michigan, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Southeastern Nephrology Associates
🇺🇸Wilmington, North Carolina, United States
Promod K. Duggal, MD, PC
🇺🇸Greenbelt, Maryland, United States
Angelo Magno, MD
🇺🇸Brooklyn, New York, United States
Dialysis Care of Hoke County
🇺🇸Raeford, North Carolina, United States
Nephrology and Internal Medicine
🇺🇸Anderson, South Carolina, United States
Charlotte Dialysis
🇺🇸Charlotte, North Carolina, United States
Med-Center Dialysis
🇺🇸Houston, Texas, United States
Reading Nephrology, Ltd.
🇺🇸West Reading, Pennsylvania, United States
Pharmaceutical Research Organization
🇺🇸Bountiful, Utah, United States
Piedmont Medical and Renal Associates
🇺🇸Martinsville, Virginia, United States
Innovative Renal Care
🇺🇸Houston, Texas, United States
Kidney Consultants fo El Paso, P.A.
🇺🇸El Paso, Texas, United States
Brenham
🇺🇸Brenham, Texas, United States
Arlington Nephrology, PA
🇺🇸Arlington, Texas, United States
DaVita Northstar Dialysis
🇺🇸Houston, Texas, United States
Purity Dialysis Centers
🇺🇸Delafield, Wisconsin, United States
Patel
🇺🇸Wichita Falls, Texas, United States
Fox Valley Nephrology Partners, SC
🇺🇸Appleton, Wisconsin, United States
Northwest Kidney Center
🇺🇸Houston, Texas, United States
Gundersen Lutheran, Ltd
🇺🇸La Crosse, Wisconsin, United States
Central Utah Clinic
🇺🇸Provo, Utah, United States
University of Vermont, Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Nephrology Associates of South Miami
🇺🇸Miami, Florida, United States
Olathe DaVita
🇺🇸Olathe, Kansas, United States
Veritas Clinical Specialists, Ltd
🇺🇸Topeka, Kansas, United States
Altru Health System Research Center
🇺🇸Grand Forks, North Dakota, United States
DaVita-Johnson County Dialysis
🇺🇸Overland Park, Kansas, United States
Dennis Artzer
🇺🇸Topeka, Kansas, United States
Renal Medical Associates
🇺🇸Lynwood, California, United States
Desert Nephrolgy Medical Group
🇺🇸Palm Springs, California, United States
Palo Alto Nephrology
🇺🇸Palo Alto, California, United States
Habib A. Tobbagi, MD
🇺🇸San Jose, California, United States
Pear Tree Dialysis
🇺🇸Ukiah, California, United States
High Desert Nephrology
🇺🇸Victorville, California, United States
Hartford North
🇺🇸Hartford, Connecticut, United States
Torrington Dialysis
🇺🇸Torrington, Connecticut, United States
Davita-Brentwood
🇺🇸Washington, District of Columbia, United States
Lee Street Dialysis
🇺🇸Washington, District of Columbia, United States
Union Plaza Dialysis Center
🇺🇸Washington, District of Columbia, United States
PAB Clinical Resesarch
🇺🇸Brandon, Florida, United States
South Florida Nephrology Group
🇺🇸Coral Springs, Florida, United States
Nephrology Consultants, PA
🇺🇸Daytona Beach, Florida, United States
DaVita Fort Myers
🇺🇸Fort Myers, Florida, United States
Nephrology Associates
🇺🇸Rochester, New York, United States
Outcomes Research International, Inc
🇺🇸Hudson, Florida, United States
Central Florida Kidney Care, PA
🇺🇸Lakeland, Florida, United States
Miami Kidney Group
🇺🇸Miami, Florida, United States
Nephrology Associates Research Center
🇺🇸Panama City, Florida, United States
A Unique Kidney Center, LLC
🇺🇸Pembroke Pines, Florida, United States
PharmResearch, Inc.
🇺🇸Pinecrest, Florida, United States
Southwest Atlanta Nephrology, PC
🇺🇸Atlanta, Georgia, United States
North Atlantic Kidney Specialist
🇺🇸Atlanta, Georgia, United States
Kidney Care Associates, LLC
🇺🇸Augusta, Georgia, United States
AtlantaDavita East
🇺🇸Atlanta, Georgia, United States
Williams Street Dialysis
🇺🇸Savannah, Georgia, United States
Renal Physicians of Georgia
🇺🇸Macon, Georgia, United States
Waycross Dialysis Facility
🇺🇸Waycross, Georgia, United States
Fox Valley Dialysis
🇺🇸Aurora, Illinois, United States
Table Rock Dialysis
🇺🇸Boise, Idaho, United States
Nampa DaVita Dialysis
🇺🇸Nampa, Idaho, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Associates in Nephrology
🇺🇸Evergreen Park, Illinois, United States
DaVita Frederick Dialysis #3373
🇺🇸Frederick, Maryland, United States
Lower Manhattan Dialysis Center
🇺🇸New York, New York, United States
Island Renal Associates, PC
🇺🇸Rockville Centre, New York, United States
Syosset Kidney Center
🇺🇸Syosset, New York, United States
Fox Valley Nephrology Partners, PC
🇺🇸Oshkosh, Wisconsin, United States
Pasadena Nephrology
🇺🇸Pasadena, California, United States
Citrus Valley Dialysis Center
🇺🇸San Bernardino, California, United States
Renal Medical Group
🇺🇸Visalia, California, United States
North Georgia Nephrology Consultant
🇺🇸Athens, Georgia, United States
Ball Memorial Hospital
🇺🇸Muncie, Indiana, United States
Douglas Dialysis
🇺🇸Douglas, Georgia, United States
TriMark Physicians Group
🇺🇸Fort Dodge, Iowa, United States
Kidney Care Associates, PLLC
🇺🇸Brooklyn, New York, United States
Celia Dill Dialysis Center
🇺🇸Carmel, New York, United States
Brookdale Physicians Dialysis associates, P.C.
🇺🇸Brooklyn, New York, United States
Nephrology Associates, PC
🇺🇸Flushing, New York, United States
University of Rochester Nephrology Unit
🇺🇸Rochester, New York, United States
Bronx Dialysis center
🇺🇸New York, New York, United States
Clinical Research Development Association, LLC
🇺🇸Springfield Gardens, New York, United States
Yonkers Nephrology, PC
🇺🇸Yonkers, New York, United States
SUNY at Stony Brook NY
🇺🇸Stony Brook, New York, United States
Albemarle Nephrology Associates
🇺🇸Elizabeth City, North Carolina, United States
Dialysis Care of Richmond County
🇺🇸Hamlet, North Carolina, United States
Nephrology Consultants of Northwest Ohio
🇺🇸Toledo, Ohio, United States
Reidsville Dialysis
🇺🇸Reidsville, North Carolina, United States
DaVita Wilson Dialysis #3032
🇺🇸Wilson, North Carolina, United States
Nephrology Assciates of Central PA, INC
🇺🇸Camp Hill, Pennsylvania, United States
Saint Elizabeth Healthcare Department of Research
🇺🇸Youngstown, Ohio, United States
NAI fo Kidney Care
🇺🇸Youngstown, Ohio, United States
Renal Care of Erie
🇺🇸Erie, Pennsylvania, United States
Exton Dialysis Center
🇺🇸Exton, Pennsylvania, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Lewistown Dialysis Center
🇺🇸Lewistown, Pennsylvania, United States
Pennyslvania Nephrology Associates, PC
🇺🇸Philadelphia, Pennsylvania, United States
Davita West Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Syed Shah
🇺🇸Saint Clair, Pennsylvania, United States
Washington Dialysis
🇺🇸Washington, Pennsylvania, United States
Dialyis Corporation of America
🇺🇸Wellsboro, Pennsylvania, United States
Reading Nephrology, Ltd
🇺🇸Wyomissing, Pennsylvania, United States
Greater Houston Kidney Specialist
🇺🇸Houston, Texas, United States
Kidney Associates, PLLC
🇺🇸Houston, Texas, United States
Peninsula Dialysis
🇺🇸Newport News, Virginia, United States
Nephrology Associates of Northern Virgina
🇺🇸Fairfax, Virginia, United States
Davita-Greater Portsmouth
🇺🇸Portsmouth, Virginia, United States
Lakewood Community Dialysis Center
🇺🇸Lakewood, Washington, United States
Saint Louis University Department of Internal Medicine
🇺🇸Saint Louis, Missouri, United States
Davita Lancaster
🇺🇸Lancaster, Pennsylvania, United States
AMS Research
🇺🇸Elmira, New York, United States
Mountain Kidney
🇺🇸Asheville, North Carolina, United States
Jefferson Nephrology Ltd
🇺🇸Charlottesville, Virginia, United States
Lawrenceburg Dialysis Center
🇺🇸Lawrenceburg, Indiana, United States
Douglas T. Domoto MD, JD, PC
🇺🇸Saint Louis, Missouri, United States
Renal Associates of Central Indiana
🇺🇸Muncie, Indiana, United States
Health Sciences Center
🇺🇸Columbia, Missouri, United States
Franklin Dialysis Center
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Research Center, Inc.
🇺🇸Birmingham, Alabama, United States
San Francisco Dialysis Center # 3830
🇺🇸San Francisco, California, United States
Capital Nephrology
🇺🇸Sacramento, California, United States
Metabolism Associates
🇺🇸New Haven, Connecticut, United States
Nephrology Associates of Central Florida
🇺🇸Orlando, Florida, United States
Tampa Bay Nephrology Associates
🇺🇸Tampa, Florida, United States
Genesis Clinical Research
🇺🇸Tampa, Florida, United States
Nephrology Associates, PLLC
🇺🇸Winston-Salem, North Carolina, United States
VA Tennessee Valley, Health Care System
🇺🇸Nashville, Tennessee, United States
University of North Carolina Division of Nephrology & Hypertension
🇺🇸Chapel Hill, North Carolina, United States
LSU Healthcare Network
🇺🇸New Orleans, Louisiana, United States
Westbank Chronic Renal Center
🇺🇸New Orleans, Louisiana, United States
Nephrology Specialists, PC
🇺🇸Richmond, Virginia, United States
Great Bridge Dialysis Center
🇺🇸Chesapeake, Virginia, United States
North Valley Nephrology
🇺🇸Yuba City, California, United States