Long Term Treatment of End Stage Renal Disease Patients With Lanthanum Carbonate (Fosrenol)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00567723
First received: December 3, 2007
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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.


Condition
Hyperphosphatemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase-IV, Long-term, Observational Safety Study in End Stage Renal Disease Subjects Treated With Lanthanum Carbonate (Fosrenol)

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Compare all-cause mortality and bone fractures among three groups of subjects with end stage renal disease (ESRD) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare the incidence of selected morbidities among three groups of patients with ESRD [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2105
Study Start Date: April 2006
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567723

  Hide Study Locations
Locations
United States, Alabama
Clinical Research Center, Inc.
Birmingham, Alabama, United States, 35213
Clinical Research Consultants
Hoover, Alabama, United States
University of South Alabama
Mobile, Alabama, United States, 36617
Montgomery Kidney Specialists
Montgomery, Alabama, United States, 36106
United States, California
California Kidney Specialist
Covina, California, United States, 91723
Atlantic Avenue Medical Clinic
Cudahy, California, United States, 90201
East Bay-South Hayward Dialysis Center
Hayward, California, United States, 94544
Renal Research Center
Los Alamitos, California, United States, 90720
Beverly Nephrology
Los Angeles, California, United States, 90048
Tower Nephrology Medical Group
Los Angeles, California, United States, 90048
USC DaVita Dialysis Center
Los Angeles, California, United States
USC Kidney Center
Los Angeles, California, United States, 90033
Renal Medical Associates
Lynwood, California, United States, 90262
Valley Renal Medical Group
Northridge, California, United States, 91324
Desert Nephrolgy Medical Group
Palm Springs, California, United States, 92262
Palo Alto Nephrology
Palo Alto, California, United States, 94304
Pasadena Nephrology
Pasadena, California, United States, 91105
Capital Nephrology
Sacramento, California, United States, 95825
Citrus Valley Dialysis Center
San Bernardino, California, United States
California Kidney Specialist
San Dimas, California, United States, 91773
San Francisco Dialysis Center # 3830
San Francisco, California, United States
Habib A. Tobbagi, MD
San Jose, California, United States, 95112
Selma DaVita Dialysis
Selma, California, United States
Pear Tree Dialysis
Ukiah, California, United States
High Desert Nephrology
Victorville, California, United States, 92395
Renal Medical Group
Visalia, California, United States, 93277
North Valley Nephrology
Yuba City, California, United States, 95991
United States, Connecticut
Hartford North
Hartford, Connecticut, United States
Metabolism Associates
New Haven, Connecticut, United States, 06511
Torrington Dialysis
Torrington, Connecticut, United States
United States, District of Columbia
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
United States, Florida
PAB Clinical Resesarch
Brandon, Florida, United States, 33511
South Florida Nephrology Group
Coral Springs, Florida, United States
Nephrology Consultants, PA
Daytona Beach, Florida, United States, 32114
DaVita Fort Myers
Fort Myers, Florida, United States
Nephrology Associates
Fort Pierce, Florida, United States, 34950
Outcomes Research International, Inc
Hudson, Florida, United States, 34668
Central Florida Kidney Care, PA
Lakeland, Florida, United States, 33805
Nephrology Associates of South Miami
Miami, Florida, United States, 33173
Miami Kidney Group
Miami, Florida, United States, 33143
Nephrology Associates of Central Florida
Orlando, Florida, United States, 32804
Nephrology Associates Research Center
Panama City, Florida, United States, 32401
A Unique Kidney Center, LLC
Pembroke Pines, Florida, United States, 33024
PharmResearch, Inc.
Pinecrest, Florida, United States, 33156
Genesis Clinical Research
Tampa, Florida, United States, 33614
Tampa Bay Nephrology Associates
Tampa, Florida, United States, 33603
United States, Georgia
North Georgia Nephrology Consultant
Athens, Georgia, United States, 30606
Davita South Fulton
Atlanta, Georgia, United States
North Atlantic Kidney Specialist
Atlanta, Georgia, United States, 30342
Southwest Atlanta Nephrology, PC
Atlanta, Georgia, United States, 30331
AtlantaDavita East
Atlanta, Georgia, United States
Kidney Care Associates, LLC
Augusta, Georgia, United States, 30901
Douglas Dialysis
Douglas, Georgia, United States
Renal Physicians of Georgia
Dublin, Georgia, United States, 31021
Renal Physicians of Georgia
Macon, Georgia, United States, 31217
Williams Street Dialysis
Savannah, Georgia, United States
Waycross Dialysis Facility
Waycross, Georgia, United States
Waycross Dialysis Facility
Waycross, Georgia, United States, 31501
United States, Idaho
Table Rock Dialysis
Boise, Idaho, United States
Nampa DaVita Dialysis
Nampa, Idaho, United States
United States, Illinois
Fox Valley Dialysis
Aurora, Illinois, United States, 60504
University of Chicago Medical Center
Chicago, Illinois, United States, 60617
Associates in Nephrology
Des Plaines, Illinois, United States, 60016
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201
Associates in Nephrology
Evergreen Park, Illinois, United States, 60805
North Suburban Nephrology, LLC
Gurnee, Illinois, United States, 60031
Lake County
Libertyville, Illinois, United States
Nephrology & Hypertension Consultants, PC
Park Ridge, Illinois, United States, 60068
Renal Care Associates
Peoria, Illinois, United States
Sauget Dialysis
Sauget, Illinois, United States, 62206
United States, Indiana
Nephrology Associates, LLC
Evansville, Indiana, United States, 47714
Nephrology Specialists PC
Gary, Indiana, United States, 46408
Lawrenceburg Dialysis Center
Lawrenceburg, Indiana, United States, 47025
Nephrology Specialists
Michigan City, Indiana, United States, 46360
Renal Associates of Central Indiana
Muncie, Indiana, United States, 47304
Ball Memorial Hospital
Muncie, Indiana, United States
Renal Associates of Central Indiana
Muncie, Indiana, United States, 47303
United States, Iowa
TriMark Physicians Group
Fort Dodge, Iowa, United States, 50501
United States, Kansas
Olathe DaVita
Olathe, Kansas, United States
DaVita-Johnson County Dialysis
Overland Park, Kansas, United States
Veritas Clinical Specialists, Ltd
Topeka, Kansas, United States, 66606
Dennis Artzer
Topeka, Kansas, United States
United States, Louisiana
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, United States, 70809
West Bank Nephrology
Marrero, Louisiana, United States, 70072
LSU Healthcare Network
New Orleans, Louisiana, United States, 70112
Westbank Chronic Renal Center
New orleans, Louisiana, United States
Northwest Louisiana Nephrology, LLC
Shreveport, Louisiana, United States, 71101
United States, Maryland
DaVita JHHS Bond Street
Baltimore, Maryland, United States
Nephrology and Hypertension
Clinton, Maryland, United States, 20735
DaVita Frederick Dialysis #3373
Frederick, Maryland, United States
Glen Burnie Dialysis Center
Glen Burnie, Maryland, United States
Promod K. Duggal, MD, PC
Greenbelt, Maryland, United States, 20770
Rivertowne Davita Dialysis
Oxon Hill, Maryland, United States, 20745
Biolab Research, LLC
Rockville, Maryland, United States, 20852
Davita of Landover
Upper Marlboro, Maryland, United States
Carroll County Dialysis Facility
Westminster, Maryland, United States, 21157
United States, Massachusetts
Horowitz and Krahn
Fall River, Massachusetts, United States, 02720
Western New England Renal Transplant Association
Springfield, Massachusetts, United States, 01107
United States, Michigan
Great Lakes Renal Network
Alma, Michigan, United States, 48801
PDI Grand Rapids East
Grand Rapids, Michigan, United States
Mid Michigan Kidney Specialists
Lansing, Michigan, United States, 48912
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Macomb Kidney Center
Warren, Michigan, United States
United States, Missouri
Health Sciences Center
Columbia, Missouri, United States, 65212
Douglas T. Domoto MD, JD, PC
Saint Louis, Missouri, United States, 63103
Washington University School of Medicine
Saint Louis, Missouri, United States, 63108
Saint Louis University Department of Internal Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Hypertension & Nephrology Associates, PA
Eatontown, New Jersey, United States, 07724
DaVita Edison
Edison, New Jersey, United States
Center for Kidney Care
Mount Laurel, New Jersey, United States
Cumberland Nephrology Associates, PA
Vineland, New Jersey, United States, 08360
United States, New York
Kidney Care Associates, PLLC
Brooklyn, New York, United States, 11212
Brookdale Physicians Dialysis associates, P.C.
Brooklyn, New York, United States
Angelo Magno, MD
Brooklyn, New York, United States, 11228
Celia Dill Dialysis Center
Carmel, New York, United States
AMS Research
Elmira, New York, United States, 14905
Nephrology Associates, PC
Flushing, New York, United States, 11355
North Shore University Hospital
Great Neck, New York, United States, 11021
Bronx Dialysis center
New York, New York, United States
Lower Manhattan Dialysis Center
New York, New York, United States, 10016
Nephrology Associates
Rochester, New York, United States, 14626
University of Rochester Nephrology Unit
Rochester, New York, United States, 14642
Island Renal Associates, PC
Rockville Centre, New York, United States, 11570
Clinical Research Development Association, LLC
Springfield Garden, New York, United States, 11413
SUNY at Stony Brook NY
Stony Brook, New York, United States, 11794
Syosset Kidney Center
Syosset, New York, United States, 11791
Yonkers Nephrology, PC
Yonkers, New York, United States, 10710
United States, North Carolina
Mountain Kidney
Ashville, North Carolina, United States, 28801
University of North Carolina Division of Nephrology & Hypertension
Chapel Hill, North Carolina, United States, 27599
Charlotte Dialysis
Charlotte, North Carolina, United States
Albemarle Nephrology Associates
Elizabeth City, North Carolina, United States, 27909
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, United States, 28401
DaVita Wilson Dialysis #3032
Wilson, North Carolina, United States
Nephrology Associates, PLLC
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Altru Health System Research Center
Grand Forks, North Dakota, United States, 58201
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45206
Nephrology Consultants of Northwest Ohio
Toledo, Ohio, United States, 43606
Saint Elizabeth Healthcare Department of Research
Youngstown, Ohio, United States, 44501
NAI fo Kidney Care
Youngstown, Ohio, United States, 44514
United States, Pennsylvania
Nephrology Assciates of Central PA, INC
Camp Hill, Pennsylvania, United States, 17011
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Renal Care of Erie
Erie, Pennsylvania, United States, 16502
Exton Dialysis Center
Exton, Pennsylvania, United States, 19341
Davita Lancaster
Lancaster, Pennsylvania, United States
Lewistown Dialysis Center
Lewistown, Pennsylvania, United States, 17044
Reading Nephrology, Ltd.
Mohnton, Pennsylvania, United States, 19540
Davita West Philadelphia
Philadelphia, Pennsylvania, United States
Franklin Dialysis Center
Philadelphia, Pennsylvania, United States
Pennyslvania Nephrology Associates, PC
Philadelphia, Pennsylvania, United States, 19106
Syed Shah
Pottsville, Pennsylvania, United States, 17901
Syed Shah
St. Claire, Pennsylvania, United States, 17970
Washington Dialysis
Washington, Pennsylvania, United States, 15301
Dialyis Corporation of America
Wellsboro, Pennsylvania, United States, 16901
Reading Nephrology, Ltd.
West Reading, Pennsylvania, United States, 19611
Reading Nephrology, Ltd
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Nephrology and Internal Medicine
Anderson, South Carolina, United States, 29621
Carolina Nephrology, PA
Greenville, South Carolina, United States, 29605
Internal Medicine Nephrology/Hypertension
Kingstree, South Carolina, United States, 29556
Charleston Nephrology Associates
North Charleston, South Carolina, United States
Southern Pines Dialysis
Southern Pines, South Carolina, United States
United States, Tennessee
G. Edward Newman, MD, PLLC
Knoxville, Tennessee, United States, 37923
Newman
Knoxville, Tennessee, United States, 37921
Internal Medicina and Nephrology
Maynardville, Tennessee, United States, 37807
Memphis Central DaVita
Memphis, Tennessee, United States
VA Tennessee Valley, Health Care System
Nashville, Tennessee, United States, 37212
United States, Texas
Arlington Nephrology, PA
Arlington, Texas, United States, 76015
Brenham
Brenham, Texas, United States
Kidney Consultants fo El Paso, P.A.
El Paso, Texas, United States
Med-Center Dialysis
Houston, Texas, United States, 77004
Northwest Kidney Center
Houston, Texas, United States, 77092
Northwest Kidney Center
Houston, Texas, United States, 77004
Innovative Renal Care
Houston, Texas, United States, 77003
Kidney Associates, PLLC
Houston, Texas, United States, 77030
Med-Center Dialysis
Houston, Texas, United States, 77002
Greater Houston Kidney Specialist
Houston, Texas, United States, 77030
DaVita Northstar Dialysis
Houston, Texas, United States
Patel
Wichita Falls, Texas, United States, 76301
United States, Utah
Pharmaceutical Research Organization
Bountiful, Utah, United States
Nephrology of Northern Utah
Ogden, Utah, United States
Central Utah Clinic
Provo, Utah, United States, 84604
United States, Vermont
University of Vermont, Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Virginia
Jefferson Nephrology Ltd
Charlottesville, Virginia, United States, 22902
Great Bridge Dialysis Center
Chesapeake, Virginia, United States
Nephrology Associates of Northern Virgina
Fairfax, Virginia, United States, 22033
Piedmont Medical and Renal Associates
Martinsville, Virginia, United States, 24112
Peninsula Dialysis
Newport News, Virginia, United States, 23604
Portsmouth Dialysis Center-DaVita
Portsmouth, Virginia, United States
Davita-Greater Portsmouth
Portsmouth, Virginia, United States
Nephrology Specialists, PC
Richmond, Virginia, United States, 23229
United States, Washington
Lakewood Community Dialysis Center
Lakewood, Washington, United States
United States, Wisconsin
Fox Valley Nephrology Partners, SC
Appleton, Wisconsin, United States, 54911
Purity Dialysis Centers
Delafield, Wisconsin, United States, 53018
Gundersen Lutheran, Ltd
LaCrosse, Wisconsin, United States, 54601
Fox Valley Nephrology Partners, PC
Oshkosh, Wisconsin, United States, 54904
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: George Porter, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00567723     History of Changes
Other Study ID Numbers: SPD405-404
Study First Received: December 3, 2007
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 11, 2014