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NCT00567723 Clinical Trial

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

Hyperphosphatemia Clinical Trial

Official title:
A Phase-IV, Long-term, Observational Safety Study in End Stage Renal Disease Subjects Treated With Lanthanum Carbonate (Fosrenol)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00567723
Other study ID # SPD405-404
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 25, 2006
Est. completion date June 7, 2016

Study information
Verified date March 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2105
Est. completion date June 7, 2016
Est. primary completion date June 7, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Great Lakes Renal Network Alma Michigan
United States Nephrology and Internal Medicine Anderson South Carolina
United States Fox Valley Nephrology Partners, SC Appleton Wisconsin
United States Arlington Nephrology, PA Arlington Texas
United States Mountain Kidney Asheville North Carolina
United States North Georgia Nephrology Consultant Athens Georgia
United States AtlantaDavita East Atlanta Georgia
United States Davita South Fulton Atlanta Georgia
United States North Atlantic Kidney Specialist Atlanta Georgia
United States Southwest Atlanta Nephrology, PC Atlanta Georgia
United States Kidney Care Associates, LLC Augusta Georgia
United States Fox Valley Dialysis Aurora Illinois
United States DaVita JHHS Bond Street Baltimore Maryland
United States Renal Associates of Baton Rouge Baton Rouge Louisiana
United States Clinical Research Center, Inc. Birmingham Alabama
United States Table Rock Dialysis Boise Idaho
United States Pharmaceutical Research Organization Bountiful Utah
United States PAB Clinical Resesarch Brandon Florida
United States Brenham Brenham Texas
United States Angelo Magno, MD Brooklyn New York
United States Brookdale Physicians Dialysis associates, P.C. Brooklyn New York
United States Kidney Care Associates, PLLC Brooklyn New York
United States University of Vermont, Fletcher Allen Health Care Burlington Vermont
United States Nephrology Assciates of Central PA, INC Camp Hill Pennsylvania
United States Celia Dill Dialysis Center Carmel New York
United States University of North Carolina Division of Nephrology & Hypertension Chapel Hill North Carolina
United States Charlotte Dialysis Charlotte North Carolina
United States Jefferson Nephrology Ltd Charlottesville Virginia
United States Great Bridge Dialysis Center Chesapeake Virginia
United States University of Chicago Medical Center Chicago Illinois
United States University of Cincinnati Cincinnati Ohio
United States Nephrology and Hypertension Clinton Maryland
United States Health Sciences Center Columbia Missouri
United States South Florida Nephrology Group Coral Springs Florida
United States California Kidney Specialist Covina California
United States Atlantic Avenue Medical Clinic Cudahy California
United States Geisinger Medical Center Danville Pennsylvania
United States Nephrology Consultants, PA Daytona Beach Florida
United States Purity Dialysis Centers Delafield Wisconsin
United States Associates in Nephrology Des Plaines Illinois
United States Douglas Dialysis Douglas Georgia
United States Renal Physicians of Georgia Dublin Georgia
United States Hypertension & Nephrology Associates, PA Eatontown New Jersey
United States DaVita Edison Edison New Jersey
United States Kidney Consultants fo El Paso, P.A. El Paso Texas
United States Albemarle Nephrology Associates Elizabeth City North Carolina
United States AMS Research Elmira New York
United States Renal Care of Erie Erie Pennsylvania
United States Evanston Northwestern Healthcare Evanston Illinois
United States Nephrology Associates, LLC Evansville Indiana
United States Associates in Nephrology Evergreen Park Illinois
United States Exton Dialysis Center Exton Pennsylvania
United States Nephrology Associates of Northern Virgina Fairfax Virginia
United States Horowitz and Krahn Fall River Massachusetts
United States Nephrology Associates, PC Flushing New York
United States TriMark Physicians Group Fort Dodge Iowa
United States DaVita Fort Myers Fort Myers Florida
United States Nephrology Associates Fort Pierce Florida
United States DaVita Frederick Dialysis #3373 Frederick Maryland
United States Nephrology Specialists PC Gary Indiana
United States Glen Burnie Dialysis Center Glen Burnie Maryland
United States Altru Health System Research Center Grand Forks North Dakota
United States PDI Grand Rapids East Grand Rapids Michigan
United States North Shore University Hospital Great Neck New York
United States Promod K. Duggal, MD, PC Greenbelt Maryland
United States Carolina Nephrology, PA Greenville South Carolina
United States North Suburban Nephrology, LLC Gurnee Illinois
United States Dialysis Care of Richmond County Hamlet North Carolina
United States Hartford North Hartford Connecticut
United States East Bay-South Hayward Dialysis Center Hayward California
United States Clinical Research Consultants Hoover Alabama
United States DaVita Northstar Dialysis Houston Texas
United States Greater Houston Kidney Specialist Houston Texas
United States Innovative Renal Care Houston Texas
United States Kidney Associates, PLLC Houston Texas
United States Med-Center Dialysis Houston Texas
United States Med-Center Dialysis Houston Texas
United States Northwest Kidney Center Houston Texas
United States Northwest Kidney Center Houston Texas
United States Outcomes Research International, Inc Hudson Florida
United States Internal Medicine Nephrology/Hypertension Kingstree South Carolina
United States G. Edward Newman, MD, PLLC Knoxville Tennessee
United States Newman Knoxville Tennessee
United States Gundersen Lutheran, Ltd La Crosse Wisconsin
United States Central Florida Kidney Care, PA Lakeland Florida
United States Lakewood Community Dialysis Center Lakewood Washington
United States Davita Lancaster Lancaster Pennsylvania
United States Mid Michigan Kidney Specialists Lansing Michigan
United States Lawrenceburg Dialysis Center Lawrenceburg Indiana
United States Lewistown Dialysis Center Lewistown Pennsylvania
United States Lake County Libertyville Illinois
United States Renal Research Center Los Alamitos California
United States Beverly Nephrology Los Angeles California
United States Tower Nephrology Medical Group Los Angeles California
United States USC DaVita Dialysis Center Los Angeles California
United States USC Kidney Center Los Angeles California
United States Renal Medical Associates Lynwood California
United States Renal Physicians of Georgia Macon Georgia
United States West Bank Nephrology Marrero Louisiana
United States Piedmont Medical and Renal Associates Martinsville Virginia
United States Internal Medicina and Nephrology Maynardville Tennessee
United States Memphis Central DaVita Memphis Tennessee
United States Miami Kidney Group Miami Florida
United States Nephrology Associates of South Miami Miami Florida
United States Nephrology Specialists Michigan City Indiana
United States University of South Alabama Mobile Alabama
United States Reading Nephrology, Ltd. Mohnton Pennsylvania
United States Montgomery Kidney Specialists Montgomery Alabama
United States Center for Kidney Care Mount Laurel New Jersey
United States Ball Memorial Hospital Muncie Indiana
United States Renal Associates of Central Indiana Muncie Indiana
United States Renal Associates of Central Indiana Muncie Indiana
United States Nampa DaVita Dialysis Nampa Idaho
United States VA Tennessee Valley, Health Care System Nashville Tennessee
United States Metabolism Associates New Haven Connecticut
United States LSU Healthcare Network New Orleans Louisiana
United States Westbank Chronic Renal Center New Orleans Louisiana
United States Bronx Dialysis center New York New York
United States Lower Manhattan Dialysis Center New York New York
United States Peninsula Dialysis Newport News Virginia
United States Charleston Nephrology Associates North Charleston South Carolina
United States Valley Renal Medical Group Northridge California
United States Nephrology of Northern Utah Ogden Utah
United States Olathe DaVita Olathe Kansas
United States Nephrology Associates of Central Florida Orlando Florida
United States Fox Valley Nephrology Partners, PC Oshkosh Wisconsin
United States DaVita-Johnson County Dialysis Overland Park Kansas
United States Rivertowne Davita Dialysis Oxon Hill Maryland
United States Desert Nephrolgy Medical Group Palm Springs California
United States Palo Alto Nephrology Palo Alto California
United States Nephrology Associates Research Center Panama City Florida
United States Nephrology & Hypertension Consultants, PC Park Ridge Illinois
United States Pasadena Nephrology Pasadena California
United States A Unique Kidney Center, LLC Pembroke Pines Florida
United States Renal Care Associates Peoria Illinois
United States Davita West Philadelphia Philadelphia Pennsylvania
United States Franklin Dialysis Center Philadelphia Pennsylvania
United States Pennyslvania Nephrology Associates, PC Philadelphia Pennsylvania
United States PharmResearch, Inc. Pinecrest Florida
United States Davita-Greater Portsmouth Portsmouth Virginia
United States Portsmouth Dialysis Center-DaVita Portsmouth Virginia
United States Syed Shah Pottsville Pennsylvania
United States Central Utah Clinic Provo Utah
United States Dialysis Care of Hoke County Raeford North Carolina
United States Reidsville Dialysis Reidsville North Carolina
United States Nephrology Specialists, PC Richmond Virginia
United States Nephrology Associates Rochester New York
United States University of Rochester Nephrology Unit Rochester New York
United States Biolab Research, LLC Rockville Maryland
United States Island Renal Associates, PC Rockville Centre New York
United States William Beaumont Hospital Royal Oak Michigan
United States Capital Nephrology Sacramento California
United States Syed Shah Saint Clair Pennsylvania
United States Douglas T. Domoto MD, JD, PC Saint Louis Missouri
United States Saint Louis University Department of Internal Medicine Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Citrus Valley Dialysis Center San Bernardino California
United States California Kidney Specialist San Dimas California
United States San Francisco Dialysis Center # 3830 San Francisco California
United States Habib A. Tobbagi, MD San Jose California
United States Sauget Dialysis Sauget Illinois
United States Williams Street Dialysis Savannah Georgia
United States Selma DaVita Dialysis Selma California
United States Northwest Louisiana Nephrology, LLC Shreveport Louisiana
United States Southern Pines Dialysis Southern Pines South Carolina
United States Western New England Renal Transplant Association Springfield Massachusetts
United States Clinical Research Development Association, LLC Springfield Gardens New York
United States SUNY at Stony Brook NY Stony Brook New York
United States Syosset Kidney Center Syosset New York
United States Genesis Clinical Research Tampa Florida
United States Tampa Bay Nephrology Associates Tampa Florida
United States Nephrology Consultants of Northwest Ohio Toledo Ohio
United States Dennis Artzer Topeka Kansas
United States Veritas Clinical Specialists, Ltd Topeka Kansas
United States Torrington Dialysis Torrington Connecticut
United States Pear Tree Dialysis Ukiah California
United States Davita of Landover Upper Marlboro Maryland
United States High Desert Nephrology Victorville California
United States Cumberland Nephrology Associates, PA Vineland New Jersey
United States Renal Medical Group Visalia California
United States Macomb Kidney Center Warren Michigan
United States 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 Washington Dialysis Washington Pennsylvania
United States Waycross Dialysis Facility Waycross Georgia
United States Waycross Dialysis Facility Waycross Georgia
United States Dialyis Corporation of America Wellsboro Pennsylvania
United States Reading Nephrology, Ltd. West Reading Pennsylvania
United States Carroll County Dialysis Facility Westminster Maryland
United States Patel Wichita Falls Texas
United States Southeastern Nephrology Associates Wilmington North Carolina
United States DaVita Wilson Dialysis #3032 Wilson North Carolina
United States Nephrology Associates, PLLC Winston-Salem North Carolina
United States Reading Nephrology, Ltd Wyomissing Pennsylvania
United States Yonkers Nephrology, PC Yonkers New York
United States NAI fo Kidney Care Youngstown Ohio
United States Saint Elizabeth Healthcare Department of Research Youngstown Ohio
United States North Valley Nephrology Yuba City California

Sponsors (1)
Lead Sponsor Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Compare all-cause mortality and bone fractures among three groups of subjects with end stage renal disease (ESRD) 5 years
Secondary Compare the incidence of selected morbidities among three groups of patients with ESRD 5 years
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT02237534 - Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia Phase 4
Completed NCT01252771 - Phosphate Kinetic Modeling 2 Phase 4
Completed NCT01187628 - Long-term Study in Chronic Kidney Disease (Extension From Study 14817) Phase 3
Unknown status NCT01245517 - The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient N/A
Completed NCT00506441 - A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia Phase 3
Recruiting NCT04440696 - To Evaluate the Patient Tolerance, Pharmacodynamics and Pharmacokinetics of Lanthanum Polystyrene Sulfonate Powder Phase 1/Phase 2
Completed NCT01976572 - Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects Phase 1
Completed NCT01742585 - A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis Phase 3
Completed NCT01191255 - A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis Phase 3
Completed NCT01003223 - Phosphate Kinetic Modeling N/A
Completed NCT00505037 - A Phase 2 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis Phase 2
Completed NCT00508885 - The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients Phase 1/Phase 2
Completed NCT04551300 - A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients Phase 2
Completed NCT01955876 - Fosrenol Post-marketing Surveillance in Japan N/A
Completed NCT04579315 - Long-term Effects of the New Nordic Renal Diet in Patients With Moderate Chronic Kidney Disease N/A
Completed NCT03861247 - Individualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients Phase 3
Terminated NCT01725113 - Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol Phase 4
Recruiting NCT01238588 - The Effect(s) of Sevelamer Carbonate (Renvela) on Atherosclerotic Plaque Inflammation Judged by FDG-PET Scan N/A
Completed NCT00542815 - A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia Phase 3
Completed NCT04549597 - Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia Phase 4

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