Hyperphosphatemia Clinical Trial
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
| NCT number | NCT00557323 |
| Other study ID # | SPD405-402 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 15, 2007 |
| Est. completion date | August 31, 2010 |
| Verified date | June 2021 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 34 |
| Est. completion date | August 31, 2010 |
| Est. primary completion date | August 31, 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Any patient who had exposure to lanthanum carbonate in SPD405-309 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | KfH Zentrum | Aachen | |
| Germany | Dialysenzentrum | Bad Homburg | |
| Germany | KfH Dialysezentrum | Berlin | |
| Germany | KfH Kuratorium duer Dialyse und Nierentransplanta Dialysezentrum Moabit | Berlin | |
| Germany | Dialysepraxis Altona | Hamburg | |
| Germany | Dialysezentrum Barmbek | Hamburg | |
| Germany | KfH Dialysezentrum | Rosenheim | |
| United Kingdom | Addenbrooke's Hospital | Cambridge | |
| United Kingdom | St. Helier Hospital | Carshalton | |
| United Kingdom | Manchester Royal Infirmary | Manchester | |
| United States | University of Vermont | Burlington | Vermont |
| United States | Mercy Medical Center | Canton | Ohio |
| United States | Imperial care Dialysis Center | Lynwood | California |
| United States | Nephrology Associates, PC | Nashville | Tennessee |
| United States | Hypertension & Nephrology, Inc. | Providence | Rhode Island |
| United States | Nephrology Associates, PC | Richmond | Virginia |
| United States | Western new England Renal & Transplant Associates | Springfield | Massachusetts |
| United States | Barnett Research and Communications Medical Group | Torrance | California |
| Lead Sponsor | Collaborator |
|---|---|
| Shire |
United States, Germany, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Study-emergent Bone-related Adverse Events (AEs) | 5 years | ||
| Secondary | Number of Study-emergent Deaths | 5 years |
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|---|---|---|---|
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