Long-term Effect of Lanthanum Carbonate on Bone

Sponsor
Shire (Industry)
Overall Status
Completed
CT.gov ID
NCT00557323
Collaborator
(none)
34
19
41.6
1.8
0

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
  • Drug: Lanthanum carbonate

Study Design

Study Type:
Observational
Actual Enrollment :
34 participants
Observational Model:
Cohort
Time Perspective:
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
Actual Study Start Date :
Mar 15, 2007
Actual Primary Completion Date :
Aug 31, 2010
Actual Study Completion Date :
Aug 31, 2010

Arms and Interventions

Arm Intervention/Treatment
1

Patients being treated for hyperphosphatemia with any marketed product

Drug: Lanthanum carbonate

Outcome Measures

Primary Outcome Measures

  1. Number of Study-emergent Bone-related Adverse Events (AEs) [5 years]

Secondary Outcome Measures

  1. Number of Study-emergent Deaths [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Shire
ClinicalTrials.gov Identifier:
NCT00557323
Other Study ID Numbers:
  • SPD405-402
First Posted:
Nov 14, 2007
Last Update Posted:
Jul 13, 2021
Last Verified:
Jun 1, 2021
Additional relevant MeSH terms:

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

1. Primary Outcome
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
2. Secondary Outcome
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

[Not Specified]

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
Email ClinicalTransparency@shire.com
Responsible Party:
Shire
ClinicalTrials.gov Identifier:
NCT00557323
Other Study ID Numbers:
  • SPD405-402
First Posted:
Nov 14, 2007
Last Update Posted:
Jul 13, 2021
Last Verified:
Jun 1, 2021