Long Term Treatment of End Stage Renal Disease Patients With Lanthanum Carbonate (Fosrenol)
Sponsor
Shire (Industry)
Overall Status
Completed
CT.gov ID
NCT00567723
Collaborator
(none)
2,105
199
121.4
10.6
0.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
2105 participants
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)
Actual Study Start Date
:
Apr 25, 2006
Actual Primary Completion Date
:
Jun 7, 2016
Actual Study Completion Date
:
Jun 7, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Outcome Measures
Primary Outcome Measures
- Compare all-cause mortality and bone fractures among three groups of subjects with end stage renal disease (ESRD) [5 years]
Secondary Outcome Measures
- Compare the incidence of selected morbidities among three groups of patients with ESRD [5 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Research Center, Inc. | Birmingham | Alabama | United States | 35213 |
| 2 | Clinical Research Consultants | Hoover | Alabama | United States | |
| 3 | University of South Alabama | Mobile | Alabama | United States | 36617 |
| 4 | Montgomery Kidney Specialists | Montgomery | Alabama | United States | 36106 |
| 5 | California Kidney Specialist | Covina | California | United States | 91723 |
| 6 | Atlantic Avenue Medical Clinic | Cudahy | California | United States | 90201 |
| 7 | East Bay-South Hayward Dialysis Center | Hayward | California | United States | 94544 |
| 8 | Renal Research Center | Los Alamitos | California | United States | 90720 |
| 9 | USC Kidney Center | Los Angeles | California | United States | 90033 |
| 10 | Beverly Nephrology | Los Angeles | California | United States | 90048 |
| 11 | Tower Nephrology Medical Group | Los Angeles | California | United States | 90048 |
| 12 | USC DaVita Dialysis Center | Los Angeles | California | United States | |
| 13 | Renal Medical Associates | Lynwood | California | United States | 90262 |
| 14 | Valley Renal Medical Group | Northridge | California | United States | 91324 |
| 15 | Desert Nephrolgy Medical Group | Palm Springs | California | United States | 92262 |
| 16 | Palo Alto Nephrology | Palo Alto | California | United States | 94304 |
| 17 | Pasadena Nephrology | Pasadena | California | United States | 91105 |
| 18 | Capital Nephrology | Sacramento | California | United States | 95825 |
| 19 | Citrus Valley Dialysis Center | San Bernardino | California | United States | |
| 20 | California Kidney Specialist | San Dimas | California | United States | 91773 |
| 21 | San Francisco Dialysis Center # 3830 | San Francisco | California | United States | |
| 22 | Habib A. Tobbagi, MD | San Jose | California | United States | 95112 |
| 23 | Selma DaVita Dialysis | Selma | California | United States | |
| 24 | Pear Tree Dialysis | Ukiah | California | United States | |
| 25 | High Desert Nephrology | Victorville | California | United States | 92395 |
| 26 | Renal Medical Group | Visalia | California | United States | 93277 |
| 27 | North Valley Nephrology | Yuba City | California | United States | 95991 |
| 28 | Hartford North | Hartford | Connecticut | United States | |
| 29 | Metabolism Associates | New Haven | Connecticut | United States | 06511 |
| 30 | Torrington Dialysis | Torrington | Connecticut | United States | |
| 31 | Davita-Brentwood | Washington | District of Columbia | United States | |
| 32 | Lee Street Dialysis | Washington | District of Columbia | United States | |
| 33 | Union Plaza Dialysis Center | Washington | District of Columbia | United States | |
| 34 | PAB Clinical Resesarch | Brandon | Florida | United States | 33511 |
| 35 | South Florida Nephrology Group | Coral Springs | Florida | United States | |
| 36 | Nephrology Consultants, PA | Daytona Beach | Florida | United States | 32114 |
| 37 | DaVita Fort Myers | Fort Myers | Florida | United States | |
| 38 | Nephrology Associates | Fort Pierce | Florida | United States | 34950 |
| 39 | Outcomes Research International, Inc | Hudson | Florida | United States | 34668 |
| 40 | Central Florida Kidney Care, PA | Lakeland | Florida | United States | 33805 |
| 41 | Miami Kidney Group | Miami | Florida | United States | 33143 |
| 42 | Nephrology Associates of South Miami | Miami | Florida | United States | 33173 |
| 43 | Nephrology Associates of Central Florida | Orlando | Florida | United States | 32804 |
| 44 | Nephrology Associates Research Center | Panama City | Florida | United States | 32401 |
| 45 | A Unique Kidney Center, LLC | Pembroke Pines | Florida | United States | 33024 |
| 46 | PharmResearch, Inc. | Pinecrest | Florida | United States | 33156 |
| 47 | Tampa Bay Nephrology Associates | Tampa | Florida | United States | 33603 |
| 48 | Genesis Clinical Research | Tampa | Florida | United States | 33614 |
| 49 | North Georgia Nephrology Consultant | Athens | Georgia | United States | 30606 |
| 50 | Southwest Atlanta Nephrology, PC | Atlanta | Georgia | United States | 30331 |
| 51 | North Atlantic Kidney Specialist | Atlanta | Georgia | United States | 30342 |
| 52 | AtlantaDavita East | Atlanta | Georgia | United States | |
| 53 | Davita South Fulton | Atlanta | Georgia | United States | |
| 54 | Kidney Care Associates, LLC | Augusta | Georgia | United States | 30901 |
| 55 | Douglas Dialysis | Douglas | Georgia | United States | |
| 56 | Renal Physicians of Georgia | Dublin | Georgia | United States | 31021 |
| 57 | Renal Physicians of Georgia | Macon | Georgia | United States | 31217 |
| 58 | Williams Street Dialysis | Savannah | Georgia | United States | |
| 59 | Waycross Dialysis Facility | Waycross | Georgia | United States | 31501 |
| 60 | Waycross Dialysis Facility | Waycross | Georgia | United States | |
| 61 | Table Rock Dialysis | Boise | Idaho | United States | |
| 62 | Nampa DaVita Dialysis | Nampa | Idaho | United States | |
| 63 | Fox Valley Dialysis | Aurora | Illinois | United States | 60504 |
| 64 | University of Chicago Medical Center | Chicago | Illinois | United States | 60617 |
| 65 | Associates in Nephrology | Des Plaines | Illinois | United States | 60016 |
| 66 | Evanston Northwestern Healthcare | Evanston | Illinois | United States | 60201 |
| 67 | Associates in Nephrology | Evergreen Park | Illinois | United States | 60805 |
| 68 | North Suburban Nephrology, LLC | Gurnee | Illinois | United States | 60031 |
| 69 | Lake County | Libertyville | Illinois | United States | |
| 70 | Nephrology & Hypertension Consultants, PC | Park Ridge | Illinois | United States | 60068 |
| 71 | Renal Care Associates | Peoria | Illinois | United States | |
| 72 | Sauget Dialysis | Sauget | Illinois | United States | 62206 |
| 73 | Nephrology Associates, LLC | Evansville | Indiana | United States | 47714 |
| 74 | Nephrology Specialists PC | Gary | Indiana | United States | 46408 |
| 75 | Lawrenceburg Dialysis Center | Lawrenceburg | Indiana | United States | 47025 |
| 76 | Nephrology Specialists | Michigan City | Indiana | United States | 46360 |
| 77 | Renal Associates of Central Indiana | Muncie | Indiana | United States | 47303 |
| 78 | Renal Associates of Central Indiana | Muncie | Indiana | United States | 47304 |
| 79 | Ball Memorial Hospital | Muncie | Indiana | United States | |
| 80 | TriMark Physicians Group | Fort Dodge | Iowa | United States | 50501 |
| 81 | Olathe DaVita | Olathe | Kansas | United States | |
| 82 | DaVita-Johnson County Dialysis | Overland Park | Kansas | United States | |
| 83 | Veritas Clinical Specialists, Ltd | Topeka | Kansas | United States | 66606 |
| 84 | Dennis Artzer | Topeka | Kansas | United States | |
| 85 | Renal Associates of Baton Rouge | Baton Rouge | Louisiana | United States | 70809 |
| 86 | West Bank Nephrology | Marrero | Louisiana | United States | 70072 |
| 87 | LSU Healthcare Network | New Orleans | Louisiana | United States | 70112 |
| 88 | Westbank Chronic Renal Center | New Orleans | Louisiana | United States | |
| 89 | Northwest Louisiana Nephrology, LLC | Shreveport | Louisiana | United States | 71101 |
| 90 | DaVita JHHS Bond Street | Baltimore | Maryland | United States | |
| 91 | Nephrology and Hypertension | Clinton | Maryland | United States | 20735 |
| 92 | DaVita Frederick Dialysis #3373 | Frederick | Maryland | United States | |
| 93 | Glen Burnie Dialysis Center | Glen Burnie | Maryland | United States | |
| 94 | Promod K. Duggal, MD, PC | Greenbelt | Maryland | United States | 20770 |
| 95 | Rivertowne Davita Dialysis | Oxon Hill | Maryland | United States | 20745 |
| 96 | Biolab Research, LLC | Rockville | Maryland | United States | 20852 |
| 97 | Davita of Landover | Upper Marlboro | Maryland | United States | |
| 98 | Carroll County Dialysis Facility | Westminster | Maryland | United States | 21157 |
| 99 | Horowitz and Krahn | Fall River | Massachusetts | United States | 02720 |
| 100 | Western New England Renal Transplant Association | Springfield | Massachusetts | United States | 01107 |
| 101 | Great Lakes Renal Network | Alma | Michigan | United States | 48801 |
| 102 | PDI Grand Rapids East | Grand Rapids | Michigan | United States | |
| 103 | Mid Michigan Kidney Specialists | Lansing | Michigan | United States | 48912 |
| 104 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48073 |
| 105 | Macomb Kidney Center | Warren | Michigan | United States | |
| 106 | Health Sciences Center | Columbia | Missouri | United States | 65212 |
| 107 | Douglas T. Domoto MD, JD, PC | Saint Louis | Missouri | United States | 63103 |
| 108 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63108 |
| 109 | Saint Louis University Department of Internal Medicine | Saint Louis | Missouri | United States | 63110 |
| 110 | Hypertension & Nephrology Associates, PA | Eatontown | New Jersey | United States | 07724 |
| 111 | DaVita Edison | Edison | New Jersey | United States | |
| 112 | Center for Kidney Care | Mount Laurel | New Jersey | United States | |
| 113 | Cumberland Nephrology Associates, PA | Vineland | New Jersey | United States | 08360 |
| 114 | Kidney Care Associates, PLLC | Brooklyn | New York | United States | 11212 |
| 115 | Angelo Magno, MD | Brooklyn | New York | United States | 11228 |
| 116 | Brookdale Physicians Dialysis associates, P.C. | Brooklyn | New York | United States | |
| 117 | Celia Dill Dialysis Center | Carmel | New York | United States | |
| 118 | AMS Research | Elmira | New York | United States | 14905 |
| 119 | Nephrology Associates, PC | Flushing | New York | United States | 11355 |
| 120 | North Shore University Hospital | Great Neck | New York | United States | 11021 |
| 121 | Lower Manhattan Dialysis Center | New York | New York | United States | 10016 |
| 122 | Bronx Dialysis center | New York | New York | United States | |
| 123 | Nephrology Associates | Rochester | New York | United States | 14626 |
| 124 | University of Rochester Nephrology Unit | Rochester | New York | United States | 14642 |
| 125 | Island Renal Associates, PC | Rockville Centre | New York | United States | 11570 |
| 126 | Clinical Research Development Association, LLC | Springfield Gardens | New York | United States | 11413 |
| 127 | SUNY at Stony Brook NY | Stony Brook | New York | United States | 11794 |
| 128 | Syosset Kidney Center | Syosset | New York | United States | 11791 |
| 129 | Yonkers Nephrology, PC | Yonkers | New York | United States | 10710 |
| 130 | Mountain Kidney | Asheville | North Carolina | United States | 28801 |
| 131 | University of North Carolina Division of Nephrology & Hypertension | Chapel Hill | North Carolina | United States | 27599 |
| 132 | Charlotte Dialysis | Charlotte | North Carolina | United States | |
| 133 | Albemarle Nephrology Associates | Elizabeth City | North Carolina | United States | 27909 |
| 134 | Dialysis Care of Richmond County | Hamlet | North Carolina | United States | |
| 135 | Dialysis Care of Hoke County | Raeford | North Carolina | United States | |
| 136 | Reidsville Dialysis | Reidsville | North Carolina | United States | |
| 137 | Southeastern Nephrology Associates | Wilmington | North Carolina | United States | 28401 |
| 138 | DaVita Wilson Dialysis #3032 | Wilson | North Carolina | United States | |
| 139 | Nephrology Associates, PLLC | Winston-Salem | North Carolina | United States | 27103 |
| 140 | Altru Health System Research Center | Grand Forks | North Dakota | United States | 58201 |
| 141 | University of Cincinnati | Cincinnati | Ohio | United States | 45206 |
| 142 | Nephrology Consultants of Northwest Ohio | Toledo | Ohio | United States | 43606 |
| 143 | Saint Elizabeth Healthcare Department of Research | Youngstown | Ohio | United States | 44501 |
| 144 | NAI fo Kidney Care | Youngstown | Ohio | United States | 44514 |
| 145 | Nephrology Assciates of Central PA, INC | Camp Hill | Pennsylvania | United States | 17011 |
| 146 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822 |
| 147 | Renal Care of Erie | Erie | Pennsylvania | United States | 16502 |
| 148 | Exton Dialysis Center | Exton | Pennsylvania | United States | 19341 |
| 149 | Davita Lancaster | Lancaster | Pennsylvania | United States | |
| 150 | Lewistown Dialysis Center | Lewistown | Pennsylvania | United States | 17044 |
| 151 | Reading Nephrology, Ltd. | Mohnton | Pennsylvania | United States | 19540 |
| 152 | Pennyslvania Nephrology Associates, PC | Philadelphia | Pennsylvania | United States | 19106 |
| 153 | Davita West Philadelphia | Philadelphia | Pennsylvania | United States | |
| 154 | Franklin Dialysis Center | Philadelphia | Pennsylvania | United States | |
| 155 | Syed Shah | Pottsville | Pennsylvania | United States | 17901 |
| 156 | Syed Shah | Saint Clair | Pennsylvania | United States | 17970 |
| 157 | Washington Dialysis | Washington | Pennsylvania | United States | 15301 |
| 158 | Dialyis Corporation of America | Wellsboro | Pennsylvania | United States | 16901 |
| 159 | Reading Nephrology, Ltd. | West Reading | Pennsylvania | United States | 19611 |
| 160 | Reading Nephrology, Ltd | Wyomissing | Pennsylvania | United States | 19610 |
| 161 | Nephrology and Internal Medicine | Anderson | South Carolina | United States | 29621 |
| 162 | Carolina Nephrology, PA | Greenville | South Carolina | United States | 29605 |
| 163 | Internal Medicine Nephrology/Hypertension | Kingstree | South Carolina | United States | 29556 |
| 164 | Charleston Nephrology Associates | North Charleston | South Carolina | United States | |
| 165 | Southern Pines Dialysis | Southern Pines | South Carolina | United States | |
| 166 | Newman | Knoxville | Tennessee | United States | 37921 |
| 167 | G. Edward Newman, MD, PLLC | Knoxville | Tennessee | United States | 37923 |
| 168 | Internal Medicina and Nephrology | Maynardville | Tennessee | United States | 37807 |
| 169 | Memphis Central DaVita | Memphis | Tennessee | United States | |
| 170 | VA Tennessee Valley, Health Care System | Nashville | Tennessee | United States | 37212 |
| 171 | Arlington Nephrology, PA | Arlington | Texas | United States | 76015 |
| 172 | Brenham | Brenham | Texas | United States | |
| 173 | Kidney Consultants fo El Paso, P.A. | El Paso | Texas | United States | |
| 174 | Med-Center Dialysis | Houston | Texas | United States | 77002 |
| 175 | Innovative Renal Care | Houston | Texas | United States | 77003 |
| 176 | Med-Center Dialysis | Houston | Texas | United States | 77004 |
| 177 | Northwest Kidney Center | Houston | Texas | United States | 77004 |
| 178 | Greater Houston Kidney Specialist | Houston | Texas | United States | 77030 |
| 179 | Kidney Associates, PLLC | Houston | Texas | United States | 77030 |
| 180 | Northwest Kidney Center | Houston | Texas | United States | 77092 |
| 181 | DaVita Northstar Dialysis | Houston | Texas | United States | |
| 182 | Patel | Wichita Falls | Texas | United States | 76301 |
| 183 | Pharmaceutical Research Organization | Bountiful | Utah | United States | |
| 184 | Nephrology of Northern Utah | Ogden | Utah | United States | |
| 185 | Central Utah Clinic | Provo | Utah | United States | 84604 |
| 186 | University of Vermont, Fletcher Allen Health Care | Burlington | Vermont | United States | 05401 |
| 187 | Jefferson Nephrology Ltd | Charlottesville | Virginia | United States | 22902 |
| 188 | Great Bridge Dialysis Center | Chesapeake | Virginia | United States | |
| 189 | Nephrology Associates of Northern Virgina | Fairfax | Virginia | United States | 22033 |
| 190 | Piedmont Medical and Renal Associates | Martinsville | Virginia | United States | 24112 |
| 191 | Peninsula Dialysis | Newport News | Virginia | United States | 23604 |
| 192 | Davita-Greater Portsmouth | Portsmouth | Virginia | United States | |
| 193 | Portsmouth Dialysis Center-DaVita | Portsmouth | Virginia | United States | |
| 194 | Nephrology Specialists, PC | Richmond | Virginia | United States | 23229 |
| 195 | Lakewood Community Dialysis Center | Lakewood | Washington | United States | |
| 196 | Fox Valley Nephrology Partners, SC | Appleton | Wisconsin | United States | 54911 |
| 197 | Purity Dialysis Centers | Delafield | Wisconsin | United States | 53018 |
| 198 | Gundersen Lutheran, Ltd | La Crosse | Wisconsin | United States | 54601 |
| 199 | Fox Valley Nephrology Partners, PC | Oshkosh | Wisconsin | United States | 54904 |
Sponsors and Collaborators
- Shire
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Shire
ClinicalTrials.gov Identifier:
NCT00567723
Other Study ID Numbers:
- SPD405-404
First Posted:
Dec 5, 2007
Last Update Posted:
Mar 17, 2021
Last Verified:
Mar 1, 2021