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

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

ChemIDplus related topics:

Lanthanum Carbonate

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

Responsible Party:	Shire Pharmaceutical ( Timothy Whitaker, M.D. )
Study ID Numbers:	SPD405-402
First Received:	November 12, 2007
Last Updated:	April 10, 2008
ClinicalTrials.gov Identifier:	NCT00557323
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

ClinicalTrials.gov processed this record on September 22, 2008

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