Kidney Failure, ChronicPhase 4NCT00160121
Efficacy and Safety of Fosrenol in Treating Elevated Serum Phosphate Levels in Adults With End Stage Renal Disease
A Phase 4 study testing Lanthanum carbonate in people with Kidney Failure, Chronic, run by Shire.
Trial summary
The purpose of this study is to test how well lanthanum carbonate reduces the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease and to determine the patient and physician's satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Lanthanum carbonate
- How many people
- 2,500 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2005to 13 Dec 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ESRD who currently require treatment for hyperphosphatemia
Who cannot join
- Female patient who is pregnant or lactating
- Patient has used any investigational product within 30 days of screening
About this study
Official title: A Phase IV, Open-Label, Multi-Center Trial Evaluating the Efficacy of Fosrenol Compared to Existing Therapy in Adults With End Stage Renal Disease Treated for Hyperphosphatemia
The purpose of this study is to test how well lanthanum carbonate reduces the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease and to determine the patient and physician's satisfaction.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Lanthanum carbonate
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanthanum carbonateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-dialysis serum phosphorus levels at 12 weeks
Measured: Week 12
Patient satisfaction questionnaire at 12 weeks
7 question patient satisfaction questionnaire for participants to respond to how strongly they agree or disagree with their experience with the medication received in this clinical trial. Question are based on a 4 point ordinal scale of: Strongly Agree, Agree, Disagree, Strongly Disagree.
Measured: Week 12
Physician satisfaction questionnaire at 12 weeks
6 question physician satisfaction questionnaire for physicians to respond to how strongly they agree or disagree with their patient's experience with the medication received in this clinical trial. Question are based on a 4 point ordinal scale of: Strongly Agree, Agree, Disagree, Strongly Disagree.
Measured: Week 12
Patient preference questionnaire at 12 weeks
6 question patient preference questionnaire for participants to respond to whether they preferred the medication they received during this clinical trial or their previous medication.
Measured: Week 12
Physician preference questionnaire at 12 weeks
7 question physician preference questionnaire for physicians to respond to whether they preferred the medication administered during this clinical trial or their patient's previous medication.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study start10 Jan 2005
- Primary completion13 Dec 2005
- Study completion13 Dec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,500 participants
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
- NCT00160121
- Sponsor's protocol ID
- SPD405-401
- Status last verified
- Jul 2021
- First submitted
- 8 Sep 2005
- Last updated
- 2 Jul 2021
- Results posted
- No
Publications
Wilson RJ, Keith MS, Preston P, Copley JB. The real-world dose-relativity of sevelamer hydrochloride and lanthanum carbonate monotherapy in patients with end-stage renal disease. Adv Ther. 2013 Dec;30(12):1100-10. doi: 10.1007/s12325-013-0077-5. Epub 2013 Dec 5.
PubMed 24307220Keith MS, Wilson RJ, Preston P, Copley JB. Cost-minimization analysis of lanthanum carbonate versus sevelamer hydrochloride in US patients with end-stage renal disease. Clin Ther. 2014 Sep 1;36(9):1276-86. doi: 10.1016/j.clinthera.2014.06.036. Epub 2014 Jul 26.
PubMed 25069799
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open-Label, Multi-Center Trial Evaluating the Efficacy of Fosrenol Compared to Existing Therapy in Adults With End Stage Renal Disease Treated for Hyperphosphatemia
- ClinicalTrials.gov ID
- NCT00160121
- Acronym / sponsor ID
- SPD405-401
- Conditions
- Kidney Failure, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2005 (actual)
- Primary completion
- 13 Dec 2005 (actual)
- Study completion
- 13 Dec 2005 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test how well lanthanum carbonate reduces the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease and to determine the patient and physician's satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with ESRD who currently require treatment for hyperphosphatemia
Key exclusion criteria (2 listed)
- Female patient who is pregnant or lactating
- Patient has used any investigational product within 30 days of screening
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 | – |
Primary outcome
Pre-dialysis serum phosphorus levels at 12 weeks
Time frame: Week 12
Patient satisfaction questionnaire at 12 weeks
Time frame: Week 12
7 question patient satisfaction questionnaire for participants to respond to how strongly they agree or disagree with their experience with the medication received in this clinical trial. Question are based on a 4 point ordinal scale of: Strongly Agree, Agree, Disagree, Strongly Disagree.
Physician satisfaction questionnaire at 12 weeks
Time frame: Week 12
6 question physician satisfaction questionnaire for physicians to respond to how strongly they agree or disagree with their patient's experience with the medication received in this clinical trial. Question are based on a 4 point ordinal scale of: Strongly Agree, Agree, Disagree, Strongly Disagree.
Patient preference questionnaire at 12 weeks
Time frame: Week 12
6 question patient preference questionnaire for participants to respond to whether they preferred the medication they received during this clinical trial or their previous medication.
Physician preference questionnaire at 12 weeks
Time frame: Week 12
7 question physician preference questionnaire for physicians to respond to whether they preferred the medication administered during this clinical trial or their patient's previous medication.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Results publication: PubMed 24307220Wilson RJ, Keith MS, Preston P, Copley JB. The real-world dose-relativity of sevelamer hydrochloride and lanthanum carbonate monotherapy in patients with end-stage renal disease. Adv Ther. 2013 Dec;30(12):1100-10. doi: 10.1007/s12325-013-0077-5. Epub 2013 Dec 5.
- Results publication: PubMed 25069799Keith MS, Wilson RJ, Preston P, Copley JB. Cost-minimization analysis of lanthanum carbonate versus sevelamer hydrochloride in US patients with end-stage renal disease. Clin Ther. 2014 Sep 1;36(9):1276-86. doi: 10.1016/j.clinthera.2014.06.036. Epub 2014 Jul 26.
- FDA Recall InformationLink provided by the sponsor.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lanthanum carbonate in people with Kidney Failure, Chronic, run by Shire.
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 2 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 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pre-dialysis serum phosphorus levels at 12 weeks (time frame: Week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00160121, which also lists 2 linked publications.
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 2 Jul 2021.