Long Term Treatment of End Stage Renal Disease Patients With Lanthanum Carbonate (Fosrenol)
This study is ongoing, but not recruiting participants.
Sponsor:
Shire Development LLC
Information provided by (Responsible Party):
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00567723
First received: December 3, 2007
Last updated: February 14, 2013
Last verified: February 2013
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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 Development LLC:
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: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567723
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Hide Study LocationsLocations
| 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 Development LLC
Investigators
| Principal Investigator: | George Porter, MD | Oregon Health and Science University |
More Information
No publications provided
| Responsible Party: | Shire Development LLC |
| ClinicalTrials.gov Identifier: | NCT00567723 History of Changes |
| Other Study ID Numbers: | SPD405-404 |
| Study First Received: | December 3, 2007 |
| Last Updated: | February 14, 2013 |
| 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 June 17, 2013