Long Term Treatment of End Stage Renal Disease Patients With Lanthanum Carbonate (Fosrenol)
A Phase-IV, Long-term, Observational Safety Study in End Stage Renal Disease Subjects Treated With Lanthanum Carbonate (Fosrenol)
1 other identifier
observational
2,105
1 country
199
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2006
Longer than P75 for all trials
199 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2006
CompletedFirst Submitted
Initial submission to the registry
December 3, 2007
CompletedFirst Posted
Study publicly available on registry
December 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2016
CompletedMarch 17, 2021
March 1, 2021
10.1 years
December 3, 2007
March 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Compare all-cause mortality and bone fractures among three groups of subjects with end stage renal disease (ESRD)
5 years
Secondary Outcomes (1)
Compare the incidence of selected morbidities among three groups of patients with ESRD
5 years
Study Arms (3)
1
Test group: Patients who have received a minimum of 12 consecutive weeks of treatment with Fosrenol
2
Historical control group: Patients with no lanthanum exposure
3
Concomitant therapy group: Patients being treated for hyperphosphatemia with any marketed product
Eligibility Criteria
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).
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (199)
Clinical Research Center, Inc.
Birmingham, Alabama, 35213, United States
Clinical Research Consultants
Hoover, Alabama, United States
University of South Alabama
Mobile, Alabama, 36617, United States
Montgomery Kidney Specialists
Montgomery, Alabama, 36106, United States
California Kidney Specialist
Covina, California, 91723, United States
Atlantic Avenue Medical Clinic
Cudahy, California, 90201, United States
East Bay-South Hayward Dialysis Center
Hayward, California, 94544, United States
Renal Research Center
Los Alamitos, California, 90720, United States
USC Kidney Center
Los Angeles, California, 90033, United States
Beverly Nephrology
Los Angeles, California, 90048, United States
Tower Nephrology Medical Group
Los Angeles, California, 90048, United States
USC DaVita Dialysis Center
Los Angeles, California, United States
Renal Medical Associates
Lynwood, California, 90262, United States
Valley Renal Medical Group
Northridge, California, 91324, United States
Desert Nephrolgy Medical Group
Palm Springs, California, 92262, United States
Palo Alto Nephrology
Palo Alto, California, 94304, United States
Pasadena Nephrology
Pasadena, California, 91105, United States
Capital Nephrology
Sacramento, California, 95825, United States
Citrus Valley Dialysis Center
San Bernardino, California, United States
California Kidney Specialist
San Dimas, California, 91773, United States
San Francisco Dialysis Center # 3830
San Francisco, California, United States
Habib A. Tobbagi, MD
San Jose, California, 95112, United States
Selma DaVita Dialysis
Selma, California, United States
Pear Tree Dialysis
Ukiah, California, United States
High Desert Nephrology
Victorville, California, 92395, United States
Renal Medical Group
Visalia, California, 93277, United States
North Valley Nephrology
Yuba City, California, 95991, United States
Hartford North
Hartford, Connecticut, United States
Metabolism Associates
New Haven, Connecticut, 06511, United States
Torrington Dialysis
Torrington, Connecticut, United States
Davita-Brentwood
Washington D.C., District of Columbia, United States
Lee Street Dialysis
Washington D.C., District of Columbia, United States
Union Plaza Dialysis Center
Washington D.C., District of Columbia, United States
PAB Clinical Resesarch
Brandon, Florida, 33511, United States
South Florida Nephrology Group
Coral Springs, Florida, United States
Nephrology Consultants, PA
Daytona Beach, Florida, 32114, United States
DaVita Fort Myers
Fort Myers, Florida, United States
Nephrology Associates
Ft. Pierce, Florida, 34950, United States
Outcomes Research International, Inc
Hudson, Florida, 34668, United States
Central Florida Kidney Care, PA
Lakeland, Florida, 33805, United States
Miami Kidney Group
Miami, Florida, 33143, United States
Nephrology Associates of South Miami
Miami, Florida, 33173, United States
Nephrology Associates of Central Florida
Orlando, Florida, 32804, United States
Nephrology Associates Research Center
Panama City, Florida, 32401, United States
A Unique Kidney Center, LLC
Pembroke Pines, Florida, 33024, United States
PharmResearch, Inc.
Pinecrest, Florida, 33156, United States
Tampa Bay Nephrology Associates
Tampa, Florida, 33603, United States
Genesis Clinical Research
Tampa, Florida, 33614, United States
North Georgia Nephrology Consultant
Athens, Georgia, 30606, United States
Southwest Atlanta Nephrology, PC
Atlanta, Georgia, 30331, United States
North Atlantic Kidney Specialist
Atlanta, Georgia, 30342, United States
AtlantaDavita East
Atlanta, Georgia, United States
Davita South Fulton
Atlanta, Georgia, United States
Kidney Care Associates, LLC
Augusta, Georgia, 30901, United States
Douglas Dialysis
Douglas, Georgia, United States
Renal Physicians of Georgia
Dublin, Georgia, 31021, United States
Renal Physicians of Georgia
Macon, Georgia, 31217, United States
Williams Street Dialysis
Savannah, Georgia, United States
Waycross Dialysis Facility
Waycross, Georgia, 31501, United States
Waycross Dialysis Facility
Waycross, Georgia, United States
Table Rock Dialysis
Boise, Idaho, United States
Nampa DaVita Dialysis
Nampa, Idaho, United States
Fox Valley Dialysis
Aurora, Illinois, 60504, United States
University of Chicago Medical Center
Chicago, Illinois, 60617, United States
Associates in Nephrology
Des Plaines, Illinois, 60016, United States
Evanston Northwestern Healthcare
Evanston, Illinois, 60201, United States
Associates in Nephrology
Evergreen Park, Illinois, 60805, United States
North Suburban Nephrology, LLC
Gurnee, Illinois, 60031, United States
Lake County
Libertyville, Illinois, United States
Nephrology & Hypertension Consultants, PC
Park Ridge, Illinois, 60068, United States
Renal Care Associates
Peoria, Illinois, United States
Sauget Dialysis
Sauget, Illinois, 62206, United States
Nephrology Associates, LLC
Evansville, Indiana, 47714, United States
Nephrology Specialists PC
Gary, Indiana, 46408, United States
Lawrenceburg Dialysis Center
Lawrenceburg, Indiana, 47025, United States
Nephrology Specialists
Michigan City, Indiana, 46360, United States
Renal Associates of Central Indiana
Muncie, Indiana, 47303, United States
Renal Associates of Central Indiana
Muncie, Indiana, 47304, United States
Ball Memorial Hospital
Muncie, Indiana, United States
TriMark Physicians Group
Fort Dodge, Iowa, 50501, United States
Olathe DaVita
Olathe, Kansas, United States
DaVita-Johnson County Dialysis
Overland Park, Kansas, United States
Veritas Clinical Specialists, Ltd
Topeka, Kansas, 66606, United States
Dennis Artzer
Topeka, Kansas, United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, 70809, United States
West Bank Nephrology
Marrero, Louisiana, 70072, United States
LSU Healthcare Network
New Orleans, Louisiana, 70112, United States
Westbank Chronic Renal Center
New Orleans, Louisiana, United States
Northwest Louisiana Nephrology, LLC
Shreveport, Louisiana, 71101, United States
DaVita JHHS Bond Street
Baltimore, Maryland, United States
Nephrology and Hypertension
Clinton, Maryland, 20735, United States
DaVita Frederick Dialysis #3373
Frederick, Maryland, United States
Glen Burnie Dialysis Center
Glen Burnie, Maryland, United States
Promod K. Duggal, MD, PC
Greenbelt, Maryland, 20770, United States
Rivertowne Davita Dialysis
Oxon Hill, Maryland, 20745, United States
Biolab Research, LLC
Rockville, Maryland, 20852, United States
Davita of Landover
Upper Marlboro, Maryland, United States
Carroll County Dialysis Facility
Westminster, Maryland, 21157, United States
Horowitz and Krahn
Fall River, Massachusetts, 02720, United States
Western New England Renal Transplant Association
Springfield, Massachusetts, 01107, United States
Great Lakes Renal Network
Alma, Michigan, 48801, United States
PDI Grand Rapids East
Grand Rapids, Michigan, United States
Mid Michigan Kidney Specialists
Lansing, Michigan, 48912, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Macomb Kidney Center
Warren, Michigan, United States
Health Sciences Center
Columbia, Missouri, 65212, United States
Douglas T. Domoto MD, JD, PC
St Louis, Missouri, 63103, United States
Washington University School of Medicine
St Louis, Missouri, 63108, United States
Saint Louis University Department of Internal Medicine
St Louis, Missouri, 63110, United States
Hypertension & Nephrology Associates, PA
Eatontown, New Jersey, 07724, United States
DaVita Edison
Edison, New Jersey, United States
Center for Kidney Care
Mount Laurel, New Jersey, United States
Cumberland Nephrology Associates, PA
Vineland, New Jersey, 08360, United States
Kidney Care Associates, PLLC
Brooklyn, New York, 11212, United States
Angelo Magno, MD
Brooklyn, New York, 11228, United States
Brookdale Physicians Dialysis associates, P.C.
Brooklyn, New York, United States
Celia Dill Dialysis Center
Carmel, New York, United States
AMS Research
Elmira, New York, 14905, United States
Nephrology Associates, PC
Flushing, New York, 11355, United States
North Shore University Hospital
Great Neck, New York, 11021, United States
Lower Manhattan Dialysis Center
New York, New York, 10016, United States
Bronx Dialysis center
New York, New York, United States
Nephrology Associates
Rochester, New York, 14626, United States
University of Rochester Nephrology Unit
Rochester, New York, 14642, United States
Island Renal Associates, PC
Rockville Centre, New York, 11570, United States
Clinical Research Development Association, LLC
Springfield Gardens, New York, 11413, United States
SUNY at Stony Brook NY
Stony Brook, New York, 11794, United States
Syosset Kidney Center
Syosset, New York, 11791, United States
Yonkers Nephrology, PC
Yonkers, New York, 10710, United States
Mountain Kidney
Asheville, North Carolina, 28801, United States
University of North Carolina Division of Nephrology & Hypertension
Chapel Hill, North Carolina, 27599, United States
Charlotte Dialysis
Charlotte, North Carolina, United States
Albemarle Nephrology Associates
Elizabeth City, North Carolina, 27909, United States
Dialysis Care of Richmond County
Hamlet, North Carolina, United States
Dialysis Care of Hoke County
Raeford, North Carolina, United States
Reidsville Dialysis
Reidsville, North Carolina, United States
Southeastern Nephrology Associates
Wilmington, North Carolina, 28401, United States
DaVita Wilson Dialysis #3032
Wilson, North Carolina, United States
Nephrology Associates, PLLC
Winston-Salem, North Carolina, 27103, United States
Altru Health System Research Center
Grand Forks, North Dakota, 58201, United States
University of Cincinnati
Cincinnati, Ohio, 45206, United States
Nephrology Consultants of Northwest Ohio
Toledo, Ohio, 43606, United States
Saint Elizabeth Healthcare Department of Research
Youngstown, Ohio, 44501, United States
NAI fo Kidney Care
Youngstown, Ohio, 44514, United States
Nephrology Assciates of Central PA, INC
Camp Hill, Pennsylvania, 17011, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Renal Care of Erie
Erie, Pennsylvania, 16502, United States
Exton Dialysis Center
Exton, Pennsylvania, 19341, United States
Davita Lancaster
Lancaster, Pennsylvania, United States
Lewistown Dialysis Center
Lewistown, Pennsylvania, 17044, United States
Reading Nephrology, Ltd.
Mohnton, Pennsylvania, 19540, United States
Pennyslvania Nephrology Associates, PC
Philadelphia, Pennsylvania, 19106, United States
Davita West Philadelphia
Philadelphia, Pennsylvania, United States
Franklin Dialysis Center
Philadelphia, Pennsylvania, United States
Syed Shah
Pottsville, Pennsylvania, 17901, United States
Syed Shah
Saint Clair, Pennsylvania, 17970, United States
Washington Dialysis
Washington, Pennsylvania, 15301, United States
Dialyis Corporation of America
Wellsboro, Pennsylvania, 16901, United States
Reading Nephrology, Ltd.
West Reading, Pennsylvania, 19611, United States
Reading Nephrology, Ltd
Wyomissing, Pennsylvania, 19610, United States
Nephrology and Internal Medicine
Anderson, South Carolina, 29621, United States
Carolina Nephrology, PA
Greenville, South Carolina, 29605, United States
Internal Medicine Nephrology/Hypertension
Kingstree, South Carolina, 29556, United States
Charleston Nephrology Associates
North Charleston, South Carolina, United States
Southern Pines Dialysis
Southern Pines, South Carolina, United States
Newman
Knoxville, Tennessee, 37921, United States
G. Edward Newman, MD, PLLC
Knoxville, Tennessee, 37923, United States
Internal Medicina and Nephrology
Maynardville, Tennessee, 37807, United States
Memphis Central DaVita
Memphis, Tennessee, United States
VA Tennessee Valley, Health Care System
Nashville, Tennessee, 37212, United States
Arlington Nephrology, PA
Arlington, Texas, 76015, United States
Brenham
Brenham, Texas, United States
Kidney Consultants fo El Paso, P.A.
El Paso, Texas, United States
Med-Center Dialysis
Houston, Texas, 77002, United States
Innovative Renal Care
Houston, Texas, 77003, United States
Med-Center Dialysis
Houston, Texas, 77004, United States
Northwest Kidney Center
Houston, Texas, 77004, United States
Greater Houston Kidney Specialist
Houston, Texas, 77030, United States
Kidney Associates, PLLC
Houston, Texas, 77030, United States
Northwest Kidney Center
Houston, Texas, 77092, United States
DaVita Northstar Dialysis
Houston, Texas, United States
Patel
Wichita Falls, Texas, 76301, United States
Pharmaceutical Research Organization
Bountiful, Utah, United States
Nephrology of Northern Utah
Ogden, Utah, United States
Central Utah Clinic
Provo, Utah, 84604, United States
University of Vermont, Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Jefferson Nephrology Ltd
Charlottesville, Virginia, 22902, United States
Great Bridge Dialysis Center
Chesapeake, Virginia, United States
Nephrology Associates of Northern Virgina
Fairfax, Virginia, 22033, United States
Piedmont Medical and Renal Associates
Martinsville, Virginia, 24112, United States
Peninsula Dialysis
Newport News, Virginia, 23604, United States
Davita-Greater Portsmouth
Portsmouth, Virginia, United States
Portsmouth Dialysis Center-DaVita
Portsmouth, Virginia, United States
Nephrology Specialists, PC
Richmond, Virginia, 23229, United States
Lakewood Community Dialysis Center
Lakewood, Washington, United States
Fox Valley Nephrology Partners, SC
Appleton, Wisconsin, 54911, United States
Purity Dialysis Centers
Delafield, Wisconsin, 53018, United States
Gundersen Lutheran, Ltd
La Crosse, Wisconsin, 54601, United States
Fox Valley Nephrology Partners, PC
Oshkosh, Wisconsin, 54904, United States
Related Publications (2)
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.
PMID: 30352437DERIVEDHutchison 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.
PMID: 27479781DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2007
First Posted
December 5, 2007
Study Start
April 25, 2006
Primary Completion
June 7, 2016
Study Completion
June 7, 2016
Last Updated
March 17, 2021
Record last verified: 2021-03