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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients being treated for hyperphosphatemia with any marketed product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanthanum carbonate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Study-emergent Bone-related Adverse Events (AEs) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Study-emergent Deaths | 5 years |
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Inclusion Criteria:
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Any patients from study SPD405-309 who were exposed to lanthanum carbonate
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial care Dialysis Center | Lynwood | California | 90262 | United States | ||
| Barnett Research and Communications Medical Group |
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Followed subjects from study SPD405-309 (NCT00150540) for 5 years.
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| ID | Title | Description |
|---|---|---|
| FG000 | 5-Year Observational Period | Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Torrance |
| California |
| 90503-4100 |
| United States |
| Western new England Renal & Transplant Associates | Springfield | Massachusetts | 01107 | United States |
| Mercy Medical Center | Canton | Ohio | 44708 | United States |
| Hypertension & Nephrology, Inc. | Providence | Rhode Island | 02904 | United States |
| Nephrology Associates, PC | Nashville | Tennessee | 37205 | United States |
| University of Vermont | Burlington | Vermont | 05401 | United States |
| Nephrology Associates, PC | Richmond | Virginia | 23226-2022 | United States |
| Bad König | Hesse | 64732 | Germany |
| KfH Zentrum | Aachen | 52074 | Germany |
| Dialysenzentrum | Bad Homburg | 61348 | Germany |
| KfH Kuratorium duer Dialyse und Nierentransplanta Dialysezentrum Moabit | Berlin | 10559 | Germany |
| KfH Dialysezentrum | Berlin | 12045 | Germany |
| Dialysezentrum Barmbek | Hamburg | 22297 | Germany |
| Dialysepraxis Altona | Hamburg | 22767 | Germany |
| KfH Dialysezentrum | Rosenheim | 83022 | Germany |
| Addenbrooke's Hospital | Cambridge | CAMBS CB2 2QQ | United Kingdom |
| St. Helier Hospital | Carshalton | GT LON SM5 1AA | United Kingdom |
| Manchester Royal Infirmary | Manchester | GT MAN M13 9WL | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 5-Year Observational Period | Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Study-emergent Bone-related Adverse Events (AEs) | Safety Set defined as all subjects who received at least one safety measurement during the study. | Posted | Number | Bone-related AEs | 5 years |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Study-emergent Deaths | Safety Set | Posted | Number | Participants | 5 years |
|
|
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Safety Set
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 5-Year Observational Period | Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths. | 18 | 34 | 5 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders |
| |||
| Fracture nonunion | Musculoskeletal and connective tissue disorders |
| |||
| Pancytopenia | Blood and lymphatic system disorders |
| |||
| Angina pectoris | Cardiac disorders |
| |||
| Aortic valve stenosis | Cardiac disorders |
| |||
| Atrial fibrillation | Cardiac disorders |
| |||
| Cardiac arrest | Cardiac disorders |
| |||
| Cardiac failure | Cardiac disorders |
| |||
| Coronary artery disease | Cardiac disorders |
| |||
| Ventricular fibrillation | Cardiac disorders |
| |||
| Hyperparathyroidism tertiary | Endocrine disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Asthenia | General disorders |
| |||
| General physical health deterioration | General disorders |
| |||
| Malaise | General disorders |
| |||
| Multi-organ failure | General disorders |
| |||
| Pyrexia | General disorders |
| |||
| Bronchitis acute | Infections and infestations |
| |||
| Diverticulitis | Infections and infestations |
| |||
| Endocarditis | Infections and infestations |
| |||
| Gangrene | Infections and infestations |
| |||
| Gastroenteritis | Infections and infestations |
| |||
| Sepsis | Infections and infestations |
| |||
| Urinary tract infection | Infections and infestations |
| |||
| Urosepsis | Infections and infestations |
| |||
| Pacemaker complication | Injury, poisoning and procedural complications |
| |||
| Shunt stenosis | Injury, poisoning and procedural complications |
| |||
| Shunt thrombosis | Injury, poisoning and procedural complications |
| |||
| Subdural hematoma | Injury, poisoning and procedural complications |
| |||
| Ejection fraction decreased | Investigations |
| |||
| Vitamin B12 deficiency | Metabolism and nutrition disorders |
| |||
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Renal cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Cerebrovascular accident | Nervous system disorders |
| |||
| Reversible posterior leukoencephalopathy syndrome | Nervous system disorders |
| |||
| Hematuria | Renal and urinary disorders |
| |||
| Renal failure acute | Renal and urinary disorders |
| |||
| Ureteric stenosis | Renal and urinary disorders |
| |||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders |
| |||
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders |
| |||
| Aneurysm arteriovenous | Vascular disorders |
| |||
| Arterial occlusive disease | Vascular disorders |
| |||
| Peripheral occlusive disease | Vascular disorders |
| |||
| Fracture | Musculoskeletal and connective tissue disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture | Musculoskeletal and connective tissue disorders |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C119467 | lanthanum carbonate |
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| United Kingdom |
|
| Title | Measurements |
|---|---|
|
| Flat feet |
|
| Fracture nonunion |
|
| Intervertebral disc protrusion |
|
| Osteoarthritis |
|
| Osteonecrosis |
|
| Osteopenia |
|
| Osteoporosis |
|
| Pain in extremity |
|
| Renal osteodystrophy |
|
| Tendonitis |
|
|