Langtidsbehandling af nyresygdomme i slutstadiet med Lanthanum Carbonate (Fosrenol)
16. marts 2021 opdateret af: Shire
En fase-IV, langsigtet, observationel sikkerhedsundersøgelse i slutstadiet af nyresygdomme behandlet med lanthanumkarbonat (Fosrenol)
Patienter, der har været behandlet med Fosrenol i minimum 12 sammenhængende uger og er i dialyse, vil blive fulgt i 5 år for at sammenligne dødelighed, knoglebrud og forekomst af udvalgte sygeligheder for patienter uden lanthan-eksponering og til patienter, der behandles for hyperfosfatæmi med evt. markedsført produkt.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
2105
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35213
- Clinical Research Center, Inc.
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Hoover, Alabama, Forenede Stater
- Clinical Research Consultants
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Mobile, Alabama, Forenede Stater, 36617
- University of South Alabama
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Montgomery, Alabama, Forenede Stater, 36106
- Montgomery Kidney Specialists
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California
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Covina, California, Forenede Stater, 91723
- California Kidney Specialist
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Cudahy, California, Forenede Stater, 90201
- Atlantic Avenue Medical Clinic
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Hayward, California, Forenede Stater, 94544
- East Bay-South Hayward Dialysis Center
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Los Alamitos, California, Forenede Stater, 90720
- Renal Research Center
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Los Angeles, California, Forenede Stater, 90048
- Tower Nephrology Medical Group
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Los Angeles, California, Forenede Stater, 90033
- USC Kidney Center
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Los Angeles, California, Forenede Stater, 90048
- Beverly Nephrology
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Los Angeles, California, Forenede Stater
- USC DaVita Dialysis Center
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Lynwood, California, Forenede Stater, 90262
- Renal Medical Associates
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Northridge, California, Forenede Stater, 91324
- Valley Renal Medical Group
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Palm Springs, California, Forenede Stater, 92262
- Desert Nephrolgy Medical Group
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Palo Alto, California, Forenede Stater, 94304
- Palo Alto Nephrology
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Pasadena, California, Forenede Stater, 91105
- Pasadena Nephrology
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Sacramento, California, Forenede Stater, 95825
- Capital Nephrology
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San Bernardino, California, Forenede Stater
- Citrus Valley Dialysis Center
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San Dimas, California, Forenede Stater, 91773
- California Kidney Specialist
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San Francisco, California, Forenede Stater
- San Francisco Dialysis Center # 3830
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San Jose, California, Forenede Stater, 95112
- Habib A. Tobbagi, MD
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Selma, California, Forenede Stater
- Selma DaVita Dialysis
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Ukiah, California, Forenede Stater
- Pear Tree Dialysis
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Victorville, California, Forenede Stater, 92395
- High Desert Nephrology
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Visalia, California, Forenede Stater, 93277
- Renal Medical Group
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Yuba City, California, Forenede Stater, 95991
- North Valley Nephrology
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Connecticut
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Hartford, Connecticut, Forenede Stater
- Hartford North
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New Haven, Connecticut, Forenede Stater, 06511
- Metabolism Associates
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Torrington, Connecticut, Forenede Stater
- Torrington Dialysis
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District of Columbia
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Washington, District of Columbia, Forenede Stater
- Davita-Brentwood
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Washington, District of Columbia, Forenede Stater
- Lee Street Dialysis
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Washington, District of Columbia, Forenede Stater
- Union Plaza Dialysis Center
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Florida
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Brandon, Florida, Forenede Stater, 33511
- PAB Clinical Resesarch
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Coral Springs, Florida, Forenede Stater
- South Florida Nephrology Group
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Daytona Beach, Florida, Forenede Stater, 32114
- Nephrology Consultants, PA
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Fort Myers, Florida, Forenede Stater
- DaVita Fort Myers
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Fort Pierce, Florida, Forenede Stater, 34950
- Nephrology Associates
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Hudson, Florida, Forenede Stater, 34668
- Outcomes Research International, Inc
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Lakeland, Florida, Forenede Stater, 33805
- Central Florida Kidney Care, PA
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Miami, Florida, Forenede Stater, 33173
- Nephrology Associates of South Miami
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Miami, Florida, Forenede Stater, 33143
- Miami Kidney Group
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Orlando, Florida, Forenede Stater, 32804
- Nephrology Associates of Central Florida
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Panama City, Florida, Forenede Stater, 32401
- Nephrology Associates Research Center
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Pembroke Pines, Florida, Forenede Stater, 33024
- A Unique Kidney Center, LLC
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Pinecrest, Florida, Forenede Stater, 33156
- PharmResearch, Inc.
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Tampa, Florida, Forenede Stater, 33614
- Genesis Clinical Research
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Tampa, Florida, Forenede Stater, 33603
- Tampa Bay Nephrology Associates
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Georgia
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Athens, Georgia, Forenede Stater, 30606
- North Georgia Nephrology Consultant
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Atlanta, Georgia, Forenede Stater, 30331
- Southwest Atlanta Nephrology, PC
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Atlanta, Georgia, Forenede Stater, 30342
- North Atlantic Kidney Specialist
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Atlanta, Georgia, Forenede Stater
- AtlantaDavita East
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Atlanta, Georgia, Forenede Stater
- Davita South Fulton
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Augusta, Georgia, Forenede Stater, 30901
- Kidney Care Associates, LLC
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Douglas, Georgia, Forenede Stater
- Douglas Dialysis
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Dublin, Georgia, Forenede Stater, 31021
- Renal Physicians of Georgia
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Macon, Georgia, Forenede Stater, 31217
- Renal Physicians of Georgia
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Savannah, Georgia, Forenede Stater
- Williams Street Dialysis
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Waycross, Georgia, Forenede Stater, 31501
- Waycross Dialysis Facility
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Waycross, Georgia, Forenede Stater
- Waycross Dialysis Facility
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Idaho
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Boise, Idaho, Forenede Stater
- Table Rock Dialysis
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Nampa, Idaho, Forenede Stater
- Nampa DaVita Dialysis
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Illinois
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Aurora, Illinois, Forenede Stater, 60504
- Fox Valley Dialysis
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Chicago, Illinois, Forenede Stater, 60617
- University of Chicago Medical Center
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Des Plaines, Illinois, Forenede Stater, 60016
- Associates in Nephrology
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Evanston, Illinois, Forenede Stater, 60201
- Evanston Northwestern Healthcare
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Evergreen Park, Illinois, Forenede Stater, 60805
- Associates in Nephrology
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Gurnee, Illinois, Forenede Stater, 60031
- North Suburban Nephrology, LLC
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Libertyville, Illinois, Forenede Stater
- Lake County
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Park Ridge, Illinois, Forenede Stater, 60068
- Nephrology & Hypertension Consultants, PC
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Peoria, Illinois, Forenede Stater
- Renal Care Associates
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Sauget, Illinois, Forenede Stater, 62206
- Sauget Dialysis
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Indiana
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Evansville, Indiana, Forenede Stater, 47714
- Nephrology Associates, LLC
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Gary, Indiana, Forenede Stater, 46408
- Nephrology Specialists PC
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Lawrenceburg, Indiana, Forenede Stater, 47025
- Lawrenceburg Dialysis Center
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Michigan City, Indiana, Forenede Stater, 46360
- Nephrology Specialists
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Muncie, Indiana, Forenede Stater, 47303
- Renal Associates of Central Indiana
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Muncie, Indiana, Forenede Stater, 47304
- Renal Associates of Central Indiana
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Muncie, Indiana, Forenede Stater
- Ball Memorial Hospital
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Iowa
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Fort Dodge, Iowa, Forenede Stater, 50501
- TriMark Physicians Group
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Kansas
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Olathe, Kansas, Forenede Stater
- Olathe DaVita
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Overland Park, Kansas, Forenede Stater
- DaVita-Johnson County Dialysis
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Topeka, Kansas, Forenede Stater, 66606
- Veritas Clinical Specialists, Ltd
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Topeka, Kansas, Forenede Stater
- Dennis Artzer
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809
- Renal Associates of Baton Rouge
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Marrero, Louisiana, Forenede Stater, 70072
- West Bank Nephrology
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New Orleans, Louisiana, Forenede Stater, 70112
- LSU Healthcare network
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New Orleans, Louisiana, Forenede Stater
- Westbank Chronic Renal Center
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Shreveport, Louisiana, Forenede Stater, 71101
- Northwest Louisiana Nephrology, LLC
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Maryland
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Baltimore, Maryland, Forenede Stater
- DaVita JHHS Bond Street
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Clinton, Maryland, Forenede Stater, 20735
- Nephrology and Hypertension
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Frederick, Maryland, Forenede Stater
- DaVita Frederick Dialysis #3373
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Glen Burnie, Maryland, Forenede Stater
- Glen Burnie Dialysis Center
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Greenbelt, Maryland, Forenede Stater, 20770
- Promod K. Duggal, MD, PC
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Oxon Hill, Maryland, Forenede Stater, 20745
- Rivertowne Davita Dialysis
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Rockville, Maryland, Forenede Stater, 20852
- Biolab Research, LLC
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Upper Marlboro, Maryland, Forenede Stater
- Davita of Landover
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Westminster, Maryland, Forenede Stater, 21157
- Carroll County Dialysis Facility
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Massachusetts
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Fall River, Massachusetts, Forenede Stater, 02720
- Horowitz and Krahn
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Springfield, Massachusetts, Forenede Stater, 01107
- Western New England Renal Transplant Association
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Michigan
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Alma, Michigan, Forenede Stater, 48801
- Great Lakes Renal Network
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Grand Rapids, Michigan, Forenede Stater
- PDI Grand Rapids East
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Lansing, Michigan, Forenede Stater, 48912
- Mid Michigan Kidney Specialists
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Royal Oak, Michigan, Forenede Stater, 48073
- William Beaumont Hospital
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Warren, Michigan, Forenede Stater
- Macomb Kidney Center
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Missouri
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Columbia, Missouri, Forenede Stater, 65212
- Health Sciences Center
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Saint Louis, Missouri, Forenede Stater, 63108
- Washington University School of Medicine
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Saint Louis, Missouri, Forenede Stater, 63103
- Douglas T. Domoto MD, JD, PC
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Saint Louis, Missouri, Forenede Stater, 63110
- Saint Louis University Department of Internal Medicine
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New Jersey
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Eatontown, New Jersey, Forenede Stater, 07724
- Hypertension & Nephrology Associates, PA
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Edison, New Jersey, Forenede Stater
- DaVita Edison
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Mount Laurel, New Jersey, Forenede Stater
- Center for Kidney Care
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Vineland, New Jersey, Forenede Stater, 08360
- Cumberland Nephrology Associates, PA
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New York
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Brooklyn, New York, Forenede Stater, 11212
- Kidney Care Associates, PLLC
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Brooklyn, New York, Forenede Stater, 11228
- Angelo Magno, MD
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Brooklyn, New York, Forenede Stater
- Brookdale Physicians Dialysis associates, P.C.
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Carmel, New York, Forenede Stater
- Celia Dill Dialysis Center
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Elmira, New York, Forenede Stater, 14905
- AMS Research
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Flushing, New York, Forenede Stater, 11355
- Nephrology Associates, PC
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Great Neck, New York, Forenede Stater, 11021
- North Shore University Hospital
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New York, New York, Forenede Stater, 10016
- Lower Manhattan Dialysis Center
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New York, New York, Forenede Stater
- Bronx Dialysis center
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Rochester, New York, Forenede Stater, 14626
- Nephrology Associates
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Rochester, New York, Forenede Stater, 14642
- University of Rochester Nephrology Unit
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Rockville Centre, New York, Forenede Stater, 11570
- Island Renal Associates, PC
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Springfield Gardens, New York, Forenede Stater, 11413
- Clinical Research Development Association, LLC
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Stony Brook, New York, Forenede Stater, 11794
- SUNY at Stony Brook NY
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Syosset, New York, Forenede Stater, 11791
- Syosset Kidney Center
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Yonkers, New York, Forenede Stater, 10710
- Yonkers Nephrology, PC
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28801
- Mountain Kidney
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Chapel Hill, North Carolina, Forenede Stater, 27599
- University of North Carolina Division of Nephrology & Hypertension
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Charlotte, North Carolina, Forenede Stater
- Charlotte Dialysis
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Elizabeth City, North Carolina, Forenede Stater, 27909
- Albemarle Nephrology Associates
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Hamlet, North Carolina, Forenede Stater
- Dialysis Care of Richmond County
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Raeford, North Carolina, Forenede Stater
- Dialysis Care of Hoke County
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Reidsville, North Carolina, Forenede Stater
- Reidsville Dialysis
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Wilmington, North Carolina, Forenede Stater, 28401
- Southeastern Nephrology Associates
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Wilson, North Carolina, Forenede Stater
- DaVita Wilson Dialysis #3032
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Winston-Salem, North Carolina, Forenede Stater, 27103
- Nephrology Associates, PLLC
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North Dakota
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Grand Forks, North Dakota, Forenede Stater, 58201
- Altru Health System Research Center
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45206
- University of Cincinnati
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Toledo, Ohio, Forenede Stater, 43606
- Nephrology Consultants of Northwest Ohio
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Youngstown, Ohio, Forenede Stater, 44501
- Saint Elizabeth Healthcare Department of Research
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Youngstown, Ohio, Forenede Stater, 44514
- NAI fo Kidney Care
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Pennsylvania
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Camp Hill, Pennsylvania, Forenede Stater, 17011
- Nephrology Assciates of Central PA, INC
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Danville, Pennsylvania, Forenede Stater, 17822
- Geisinger Medical Center
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Erie, Pennsylvania, Forenede Stater, 16502
- Renal Care of Erie
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Exton, Pennsylvania, Forenede Stater, 19341
- Exton Dialysis Center
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Lancaster, Pennsylvania, Forenede Stater
- Davita Lancaster
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Lewistown, Pennsylvania, Forenede Stater, 17044
- Lewistown Dialysis Center
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Mohnton, Pennsylvania, Forenede Stater, 19540
- Reading Nephrology, Ltd.
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Philadelphia, Pennsylvania, Forenede Stater, 19106
- Pennyslvania Nephrology Associates, PC
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Philadelphia, Pennsylvania, Forenede Stater
- Davita West Philadelphia
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Philadelphia, Pennsylvania, Forenede Stater
- Franklin Dialysis Center
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Pottsville, Pennsylvania, Forenede Stater, 17901
- Syed Shah
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Saint Clair, Pennsylvania, Forenede Stater, 17970
- Syed Shah
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Washington, Pennsylvania, Forenede Stater, 15301
- Washington Dialysis
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Wellsboro, Pennsylvania, Forenede Stater, 16901
- Dialyis Corporation of America
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West Reading, Pennsylvania, Forenede Stater, 19611
- Reading Nephrology, Ltd.
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Wyomissing, Pennsylvania, Forenede Stater, 19610
- Reading Nephrology, Ltd
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South Carolina
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Anderson, South Carolina, Forenede Stater, 29621
- Nephrology and Internal Medicine
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Greenville, South Carolina, Forenede Stater, 29605
- Carolina Nephrology, PA
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Kingstree, South Carolina, Forenede Stater, 29556
- Internal Medicine Nephrology/Hypertension
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North Charleston, South Carolina, Forenede Stater
- Charleston Nephrology Associates
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Southern Pines, South Carolina, Forenede Stater
- Southern Pines Dialysis
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Tennessee
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Knoxville, Tennessee, Forenede Stater, 37921
- Newman
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Knoxville, Tennessee, Forenede Stater, 37923
- G. Edward Newman, MD, PLLC
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Maynardville, Tennessee, Forenede Stater, 37807
- Internal Medicina and Nephrology
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Memphis, Tennessee, Forenede Stater
- Memphis Central DaVita
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Nashville, Tennessee, Forenede Stater, 37212
- VA Tennessee Valley, Health Care System
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Texas
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Arlington, Texas, Forenede Stater, 76015
- Arlington Nephrology, PA
-
Brenham, Texas, Forenede Stater
- Brenham
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El Paso, Texas, Forenede Stater
- Kidney Consultants fo El Paso, P.A.
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Houston, Texas, Forenede Stater, 77030
- Kidney Associates, PLLC
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Houston, Texas, Forenede Stater, 77002
- Med-Center Dialysis
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Houston, Texas, Forenede Stater, 77003
- Innovative Renal Care
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Houston, Texas, Forenede Stater, 77004
- Med-Center Dialysis
-
Houston, Texas, Forenede Stater, 77004
- Northwest Kidney Center
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Houston, Texas, Forenede Stater, 77030
- Greater Houston Kidney Specialist
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Houston, Texas, Forenede Stater, 77092
- Northwest Kidney Center
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Houston, Texas, Forenede Stater
- DaVita Northstar Dialysis
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Wichita Falls, Texas, Forenede Stater, 76301
- Patel
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Utah
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Bountiful, Utah, Forenede Stater
- Pharmaceutical Research Organization
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Ogden, Utah, Forenede Stater
- Nephrology of Northern Utah
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Provo, Utah, Forenede Stater, 84604
- Central Utah Clinic
-
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Vermont
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Burlington, Vermont, Forenede Stater, 05401
- University of Vermont, Fletcher Allen Health Care
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22902
- Jefferson Nephrology Ltd
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Chesapeake, Virginia, Forenede Stater
- Great Bridge Dialysis Center
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Fairfax, Virginia, Forenede Stater, 22033
- Nephrology Associates of Northern Virgina
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Martinsville, Virginia, Forenede Stater, 24112
- Piedmont Medical and Renal Associates
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Newport News, Virginia, Forenede Stater, 23604
- Peninsula Dialysis
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Portsmouth, Virginia, Forenede Stater
- Davita-Greater Portsmouth
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Portsmouth, Virginia, Forenede Stater
- Portsmouth Dialysis Center-DaVita
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Richmond, Virginia, Forenede Stater, 23229
- Nephrology Specialists, PC
-
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Washington
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Lakewood, Washington, Forenede Stater
- Lakewood Community Dialysis Center
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Wisconsin
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Appleton, Wisconsin, Forenede Stater, 54911
- Fox Valley Nephrology Partners, SC
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Delafield, Wisconsin, Forenede Stater, 53018
- Purity Dialysis Centers
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La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran, Ltd
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Oshkosh, Wisconsin, Forenede Stater, 54904
- Fox Valley Nephrology Partners, PC
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patienter til grupperne historisk kontrol og samtidig terapi vil blive udvalgt fra United States Renal Data System (USRDS).
Testgruppen vil bestå af patienter, som har haft mindst 12 sammenhængende ugers eksponering for Fosrenol (lanthancarbonat).
Beskrivelse
Inklusionskriterier: Testgruppe
- Underskrevet informeret samtykke
- Patienten skal have ESRD og være i dialyse
- Forudgående behandling med Fosrenol i minimum 12 sammenhængende uger
- Primær betaler af sundhedsydelser skal være Medicare (patienten skal oplyse Medicare Claim Number)
- Patienten skal være 18 år eller ældre
Eksklusionskriterier: Testgruppe
- Patienter, der ikke opfylder inklusionskriterier
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
1
Testgruppe: Patienter, der har modtaget minimum 12 sammenhængende ugers behandling med Fosrenol
|
|
2
Historisk kontrolgruppe: Patienter uden eksponering for lanthan
|
|
3
Samtidig terapigruppe: Patienter, der behandles for hyperfosfatæmi med ethvert markedsført produkt
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Sammenlign dødelighed af alle årsager og knoglebrud blandt tre grupper af forsøgspersoner med nyresygdom i slutstadiet (ESRD)
Tidsramme: 5 år
|
5 år
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Sammenlign forekomsten af udvalgte morbiditeter blandt tre grupper af patienter med ESRD
Tidsramme: 5 år
|
5 år
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
25. april 2006
Primær færdiggørelse (Faktiske)
7. juni 2016
Studieafslutning (Faktiske)
7. juni 2016
Datoer for studieregistrering
Først indsendt
3. december 2007
Først indsendt, der opfyldte QC-kriterier
3. december 2007
Først opslået (Skøn)
5. december 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. marts 2021
Sidst verificeret
1. marts 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SPD405-404
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .