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Long-term Effect of Lanthanum Carbonate on Bone

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00557323
First Posted: November 14, 2007
Last Update Posted: March 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shire
  Purpose
Patients enrolled in a previous study (SPD405-309), who were exposed to lanthanum carbonate (Fosrenol), were eligible to continue on any prescribed treatment for hyperphosphatemia, including lanthanum carbonate (Fosrenol), for an additional 5 years. Patients were being observed for any bone adverse events or other serious adverse events, as well as the collection of mortality data.

Condition Intervention
Hyperphosphatemia Drug: Lanthanum carbonate

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Long-term, Observational Study to Monitor Mortality, Bone-related Adverse Events and the Safety of Subjects Who Were Recruited Into Study SPD405-309

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Number of Study-emergent Bone-related Adverse Events (AEs) [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Number of Study-emergent Deaths [ Time Frame: 5 years ]

Enrollment: 34
Study Start Date: August 2005
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients being treated for hyperphosphatemia with any marketed product
Drug: Lanthanum carbonate

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patients from study SPD405-309 who were exposed to lanthanum carbonate
Criteria

Inclusion Criteria:

  • Any patient who had exposure to lanthanum carbonate in SPD405-309
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00557323


Locations
United States, California
Imperial care Dialysis Center
Lynwood, California, United States, 90262
Barnett Research and Communications Medical Group
Torrance, California, United States, 90503-4100
United States, Massachusetts
Western new England Renal & Transplant Associates
Springfield, Massachusetts, United States, 01107
United States, Ohio
Mercy Medical Center
Canton, Ohio, United States, 44708
United States, Rhode Island
Hypertension & Nephrology, Inc.
Providence, Rhode Island, United States, 02904
United States, Tennessee
Nephrology Associates, PC
Nashville, Tennessee, United States, 37205
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
Nephrology Associates, PC
Richmond, Virginia, United States, 23226-2022
Germany
Bad Koenig, HE, Germany, 64732
KfH Zentrum
Aachen, Germany, 52074
Dialysenzentrum
Bad Homburg, Germany, 61348
KfH Kuratorium duer Dialyse und Nierentransplanta Dialysezentrum Moabit
Berlin, Germany, 10559
KfH Dialysezentrum
Berlin, Germany, 12045
Dialysezentrum Barmbek
Hamburg, Germany, 22297
Dialysepraxis Altona
Hamburg, Germany, 22767
KfH Dialysezentrum
Rosenheim, Germany, 83022
United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom, CAMBS CB2 2QQ
St. Helier Hospital
Carshalton, United Kingdom, GT LON SM5 1AA
Manchester Royal Infirmary
Manchester, United Kingdom, GT MAN M13 9WL
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Alastair Hutchison, MD Manchester Royal Infirmary, Manchester, UK
  More Information

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00557323     History of Changes
Other Study ID Numbers: SPD405-402
First Submitted: November 12, 2007
First Posted: November 14, 2007
Results First Submitted: May 19, 2011
Results First Posted: June 15, 2011
Last Update Posted: March 24, 2015
Last Verified: May 2011

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases