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

March 16, 2021 updated by: Shire

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Compare all-cause mortality and bone fractures among three groups of subjects with end stage renal disease (ESRD)
Time Frame: 5 years
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Compare the incidence of selected morbidities among three groups of patients with ESRD
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 7, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 7, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPD405-404

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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