Long-Term Effect of Lanthanum Carbonate on Bone - Full Text View

Sponsored by:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00557323

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
Hyperphosphatemia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

Monitor the emergence of bone-related adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Collect mortality data [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Collect serious adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	93
Study Start Date:	August 2005
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Eligibility

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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
KfH Dialysezentrum
Rosenheim, Germany, 83022
Dialysepraxis Altona
Hamburg, Germany, 22767
Dialysezentrum Barmbek
Hamburg, Germany, 22297
KfH Kuratorium duer Dialyse und Nierentransplanta Dialysezentrum Moabit
Berlin, Germany, 10559
Dialysenzentrum
Bad Homburg, Germany, 61348
KfH Dialysezentrum
Berlin, Germany, 12045
KfH Zentrum
Aachen, Germany, 52074
Germany, HE

Bad Koenig, HE, Germany, 64732
United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom, CAMBS CB2 2QQ
Manchester Royal Infirmary
Manchester, United Kingdom, GT MAN M13 9WL
St. Helier Hospital
Carshalton, United Kingdom, GT LON SM5 1AA

Sponsors and Collaborators

Shire Pharmaceutical Development

Investigators

Principal Investigator:

Alastair Hutchison, MD

Manchester Royal Infirmary, Manchester, UK

More Information

No publications provided

Responsible Party:	Shire Pharmaceutical ( Timothy Whitaker, M.D. )
Study ID Numbers:	SPD405-402
Study First Received:	November 12, 2007
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00557323 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Hyperphosphatemia
Metabolic Disorder

Additional relevant MeSH terms:

Phosphorus Metabolism Disorders
Metabolic Diseases
Hyperphosphatemia

ClinicalTrials.gov processed this record on May 07, 2009