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Sponsored by: |
Shire Pharmaceutical Development |
---|---|
Information provided by: | Shire Pharmaceutical Development |
ClinicalTrials.gov Identifier: | NCT00557323 |
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 |
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Hyperphosphatemia |
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 |
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) |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Any patients from study SPD405-309 who were exposed to lanthanum carbonate
Inclusion Criteria:
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 |
Principal Investigator: | Alastair Hutchison, MD | Manchester Royal Infirmary, Manchester, UK |
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 |
Metabolic Diseases Hyperphosphatemia Metabolic Disorder |
Phosphorus Metabolism Disorders Metabolic Diseases Hyperphosphatemia |