Long-term Effect of Lanthanum Carbonate on Bone
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
1 Patients being treated for hyperphosphatemia with any marketed product |
Drug: Lanthanum carbonate
|
Outcome Measures
Primary Outcome Measures
- Number of Study-emergent Bone-related Adverse Events (AEs) [5 years]
Secondary Outcome Measures
- Number of Study-emergent Deaths [5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Any patient who had exposure to lanthanum carbonate in SPD405-309
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Imperial care Dialysis Center | Lynwood | California | United States | 90262 |
2 | Barnett Research and Communications Medical Group | Torrance | California | United States | 90503-4100 |
3 | Western new England Renal & Transplant Associates | Springfield | Massachusetts | United States | 01107 |
4 | Mercy Medical Center | Canton | Ohio | United States | 44708 |
5 | Hypertension & Nephrology, Inc. | Providence | Rhode Island | United States | 02904 |
6 | Nephrology Associates, PC | Nashville | Tennessee | United States | 37205 |
7 | University of Vermont | Burlington | Vermont | United States | 05401 |
8 | Nephrology Associates, PC | Richmond | Virginia | United States | 23226-2022 |
9 | Bad Konig | HE | Germany | 64732 | |
10 | KfH Zentrum | Aachen | Germany | 52074 | |
11 | Dialysenzentrum | Bad Homburg | Germany | 61348 | |
12 | KfH Kuratorium duer Dialyse und Nierentransplanta Dialysezentrum Moabit | Berlin | Germany | 10559 | |
13 | KfH Dialysezentrum | Berlin | Germany | 12045 | |
14 | Dialysezentrum Barmbek | Hamburg | Germany | 22297 | |
15 | Dialysepraxis Altona | Hamburg | Germany | 22767 | |
16 | KfH Dialysezentrum | Rosenheim | Germany | 83022 | |
17 | Addenbrooke's Hospital | Cambridge | United Kingdom | CAMBS CB2 2QQ | |
18 | St. Helier Hospital | Carshalton | United Kingdom | GT LON SM5 1AA | |
19 | Manchester Royal Infirmary | Manchester | United Kingdom | GT MAN M13 9WL |
Sponsors and Collaborators
- Shire
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SPD405-402
Study Results
Participant Flow
Recruitment Details | Followed subjects from study SPD405-309 (NCT00150540) for 5 years. |
---|---|
Pre-assignment Detail |
Arm/Group Title | 5-Year Observational Period |
---|---|
Arm/Group Description | 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. |
Period Title: Overall Study | |
STARTED | 34 |
COMPLETED | 27 |
NOT COMPLETED | 7 |
Baseline Characteristics
Arm/Group Title | 5-Year Observational Period |
---|---|
Arm/Group Description | 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. |
Overall Participants | 34 |
Age (Years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Years] |
54.1
(13.3)
|
Sex: Female, Male (Count of Participants) | |
Female |
9
26.5%
|
Male |
25
73.5%
|
Region of Enrollment (Count of Participants) | |
United States |
12
35.3%
|
Germany |
18
52.9%
|
United Kingdom |
4
11.8%
|
Outcome Measures
Title | Number of Study-emergent Bone-related Adverse Events (AEs) |
---|---|
Description | |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
Safety Set defined as all subjects who received at least one safety measurement during the study. |
Arm/Group Title | 5-Year Observational Period |
---|---|
Arm/Group Description | 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. |
Measure Participants | 34 |
Fracture (8 subjects) |
9
|
Arthralgia (1 subject) |
2
|
Hyperparathyroidism tertiary |
1
|
Flat feet |
1
|
Fracture nonunion |
1
|
Intervertebral disc protrusion |
1
|
Osteoarthritis |
1
|
Osteonecrosis |
1
|
Osteopenia |
1
|
Osteoporosis |
1
|
Pain in extremity |
1
|
Renal osteodystrophy |
1
|
Tendonitis |
1
|
Title | Number of Study-emergent Deaths |
---|---|
Description | |
Time Frame | 5 years |
Outcome Measure Data
Analysis Population Description |
---|
Safety Set |
Arm/Group Title | 5-Year Observational Period |
---|---|
Arm/Group Description | 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. |
Measure Participants | 34 |
Number [Participants] |
3
8.8%
|
Adverse Events
Time Frame | ||
---|---|---|
Adverse Event Reporting Description | Safety Set | |
Arm/Group Title | 5-Year Observational Period | |
Arm/Group Description | 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. | |
All Cause Mortality |
||
5-Year Observational Period | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
5-Year Observational Period | ||
Affected / at Risk (%) | # Events | |
Total | 18/34 (52.9%) | |
Blood and lymphatic system disorders | ||
Pancytopenia | 1/34 (2.9%) | 1 |
Cardiac disorders | ||
Angina pectoris | 2/34 (5.9%) | 2 |
Aortic valve stenosis | 1/34 (2.9%) | 1 |
Atrial fibrillation | 1/34 (2.9%) | 2 |
Cardiac arrest | 1/34 (2.9%) | 1 |
Cardiac failure | 1/34 (2.9%) | 1 |
Coronary artery disease | 1/34 (2.9%) | 1 |
Ventricular fibrillation | 1/34 (2.9%) | 1 |
Endocrine disorders | ||
Hyperparathyroidism tertiary | 1/34 (2.9%) | 1 |
Gastrointestinal disorders | ||
Diarrhea | 1/34 (2.9%) | 1 |
General disorders | ||
Asthenia | 1/34 (2.9%) | 1 |
General physical health deterioration | 1/34 (2.9%) | 1 |
Malaise | 1/34 (2.9%) | 1 |
Multi-organ failure | 1/34 (2.9%) | 1 |
Pyrexia | 1/34 (2.9%) | 1 |
Infections and infestations | ||
Bronchitis acute | 1/34 (2.9%) | 1 |
Diverticulitis | 1/34 (2.9%) | 1 |
Endocarditis | 1/34 (2.9%) | 1 |
Gangrene | 1/34 (2.9%) | 2 |
Gastroenteritis | 1/34 (2.9%) | 1 |
Sepsis | 2/34 (5.9%) | 2 |
Urinary tract infection | 1/34 (2.9%) | 1 |
Urosepsis | 2/34 (5.9%) | 2 |
Injury, poisoning and procedural complications | ||
Pacemaker complication | 1/34 (2.9%) | 1 |
Shunt stenosis | 1/34 (2.9%) | 1 |
Shunt thrombosis | 1/34 (2.9%) | 3 |
Subdural hematoma | 1/34 (2.9%) | 1 |
Investigations | ||
Ejection fraction decreased | 1/34 (2.9%) | 1 |
Metabolism and nutrition disorders | ||
Vitamin B12 deficiency | 1/34 (2.9%) | 1 |
Musculoskeletal and connective tissue disorders | ||
Osteoarthritis | 1/34 (2.9%) | 1 |
Fracture nonunion | 1/34 (2.9%) | 1 |
Fracture | 4/34 (11.8%) | 4 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
Metastatic renal cell carcinoma | 1/34 (2.9%) | 1 |
Renal cell carcinoma stage unspecified | 1/34 (2.9%) | 1 |
Nervous system disorders | ||
Cerebrovascular accident | 1/34 (2.9%) | 1 |
Reversible posterior leukoencephalopathy syndrome | 1/34 (2.9%) | 1 |
Renal and urinary disorders | ||
Hematuria | 1/34 (2.9%) | 1 |
Renal failure acute | 1/34 (2.9%) | 2 |
Ureteric stenosis | 2/34 (5.9%) | 2 |
Respiratory, thoracic and mediastinal disorders | ||
Chronic obstructive pulmonary disease | 1/34 (2.9%) | 2 |
Pulmonary edema | 1/34 (2.9%) | 3 |
Vascular disorders | ||
Aneurysm arteriovenous | 1/34 (2.9%) | 1 |
Arterial occlusive disease | 1/34 (2.9%) | 1 |
Peripheral occlusive disease | 1/34 (2.9%) | 1 |
Other (Not Including Serious) Adverse Events |
||
5-Year Observational Period | ||
Affected / at Risk (%) | # Events | |
Total | 5/34 (14.7%) | |
Musculoskeletal and connective tissue disorders | ||
Fracture | 5/34 (14.7%) | 5 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Study Director |
---|---|
Organization | Shire |
Phone | +1 866 842 5335 |
ClinicalTransparency@shire.com |
- SPD405-402