HyperphosphatemiaNCT00557323
Long-term Effect of Lanthanum Carbonate on Bone
An observational study of Hyperphosphatemia, run by Shire at 19 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- Lanthanum carbonate
- How many people
- 34 participants
- Where
- 19 sitesin 3 countries
- Study dates
- 15 Mar 2007to 31 Aug 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patients from study SPD405-309 who were exposed to lanthanum carbonate
Who may be able to join
- Any patient who had exposure to lanthanum carbonate in SPD405-309
Who cannot join
None listed.
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
United States8 sites
University of Vermont
Burlington, Vermont, 05401
Mercy Medical Center
Canton, Ohio, 44708
Imperial care Dialysis Center
Lynwood, California, 90262
Nephrology Associates, PC
Nashville, Tennessee, 37205
Hypertension & Nephrology, Inc.
Providence, Rhode Island, 02904
Nephrology Associates, PC
Richmond, Virginia, 23226-2022
Western new England Renal & Transplant Associates
Springfield, Massachusetts, 01107
Barnett Research and Communications Medical Group
Torrance, California, 90503-4100
Germany8 sites
KfH Zentrum
Aachen, 52074
Dialysenzentrum
Bad Homburg, 61348
Study site
Bad König, Hesse, 64732
KfH Kuratorium duer Dialyse und Nierentransplanta Dialysezentrum Moabit
Berlin, 10559
KfH Dialysezentrum
Berlin, 12045
Dialysezentrum Barmbek
Hamburg, 22297
Dialysepraxis Altona
Hamburg, 22767
KfH Dialysezentrum
Rosenheim, 83022
United Kingdom3 sites
Addenbrooke's Hospital
Cambridge, CAMBS CB2 2QQ
St. Helier Hospital
Carshalton, GT LON SM5 1AA
Manchester Royal Infirmary
Manchester, GT MAN M13 9WL
About this study
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
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.
- Conditions
- Hyperphosphatemia
- Being tested
- Lanthanum carbonate
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanthanum carbonateDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients being treated for hyperphosphatemia with any marketed product Receives: Drug: Lanthanum carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Study-emergent Bone-related Adverse Events (AEs)
Measured: 5 years
Secondary outcomes (1)
Number of Study-emergent Deaths
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study start15 Mar 2007
- Primary completion31 Aug 2010
- Study completion31 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperphosphatemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557323
- Sponsor's protocol ID
- SPD405-402
- Status last verified
- Jun 2021
- First submitted
- 12 Nov 2007
- Last updated
- 13 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00557323
- Acronym / sponsor ID
- SPD405-402
- Conditions
- Hyperphosphatemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2007 (actual)
- Primary completion
- 31 Aug 2010 (actual)
- Study completion
- 31 Aug 2010 (actual)
- First posted
- 14 Nov 2007 (estimated)
- Results
- Posted 15 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Lanthanum carbonatePatients being treated for hyperphosphatemia with any marketed product |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patients from study SPD405-309 who were exposed to lanthanum carbonate
Key inclusion criteria (1 listed)
- Any patient who had exposure to lanthanum carbonate in SPD405-309
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lanthanum carbonate | Drug | 1 |
Primary outcome
Number of Study-emergent Bone-related Adverse Events (AEs)
Time frame: 5 years
1 secondary outcome
Number of Study-emergent Deaths
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperphosphatemia, run by Shire at 19 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Study-emergent Bone-related Adverse Events (AEs) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.