Kidney Failure, ChronicPhase 3NCT00151931
Efficacy and Tolerability of Treatment With Lanthanum Carbonate in Patients With End Stage Renal Disease Receiving Dialysis
A Phase 3 study testing Lanthanum carbonate in people with Kidney Failure, Chronic, run by Shire.
Trial summary
The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with lanthanum carbonate 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
- 456 participants
- Where
- No sites listed yet
- Study dates
- 11 May 2004to 12 Jan 2006
- Phase
- Phase 3
- 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
- Males and females of childbearing potential agree to take adequate precautions to prevent contraception
- Patients diagnosed with ESRD must have been receiving a stable dialysis regimen for chronic renal failure for the 2 consecutive months prior to enrollment in the study
- Patient requires treatment for hyperphosphataemia
Who cannot join
- Pregnant or lactating women
- Patients who continue to require treatment with compounds containing calcium, aluminum or magnesium
- Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma
- Patients who are HIV+
- Patients with any significant gastrointestinal surgery or disorders
About this study
Official title: A Multi-Centre, Open-Label Study Assessing the Efficacy and Tolerability of Lanthanum Carbonate in the Reduction of Serum Phosphate Levels in End Stage Renal Disease Patients Receiving Dialysis
The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with lanthanum carbonate
- 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.
Change in pre-dialysis serum phosphate levels at Week 3 compared with Week 5
Measured: Week 3 and Week 5
Secondary outcomes (1)
Treatment emergent adverse events
Measured: Throughout the study period of approximately 20 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study start11 May 2004
- Primary completion12 Jan 2006
- Study completion12 Jan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 456 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
- NCT00151931
- Sponsor's protocol ID
- SPD405-313
- Status last verified
- Jun 2021
- First submitted
- 7 Sep 2005
- Last updated
- 8 Jun 2021
- Results posted
- No
Publications
Hutchison AJ, Laville M; SPD405-313 Lanthanum Study Group. Switching to lanthanum carbonate monotherapy provides effective phosphate control with a low tablet burden. Nephrol Dial Transplant. 2008 Nov;23(11):3677-84. doi: 10.1093/ndt/gfn310. Epub 2008 Jun 24.
PubMed 18577536
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Open-Label Study Assessing the Efficacy and Tolerability of Lanthanum Carbonate in the Reduction of Serum Phosphate Levels in End Stage Renal Disease Patients Receiving Dialysis
- ClinicalTrials.gov ID
- NCT00151931
- Acronym / sponsor ID
- SPD405-313
- Conditions
- Kidney Failure, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 11 May 2004 (actual)
- Primary completion
- 12 Jan 2006 (actual)
- Study completion
- 12 Jan 2006 (actual)
- First posted
- 9 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 assess phosphate reduction and control in patients with End Stage Renal Disease treated with lanthanum carbonate
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 (3 listed)
- Males and females of childbearing potential agree to take adequate precautions to prevent contraception
- Patients diagnosed with ESRD must have been receiving a stable dialysis regimen for chronic renal failure for the 2 consecutive months prior to enrollment in the study
- Patient requires treatment for hyperphosphataemia
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- Patients who continue to require treatment with compounds containing calcium, aluminum or magnesium
- Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma
- Patients who are HIV+
- Patients with any significant gastrointestinal surgery or disorders
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
Change in pre-dialysis serum phosphate levels at Week 3 compared with Week 5
Time frame: Week 3 and Week 5
1 secondary outcome
Treatment emergent adverse events
Time frame: Throughout the study period of approximately 20 months.
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 8 Jun 2021.
- Background: PubMed 18577536Hutchison AJ, Laville M; SPD405-313 Lanthanum Study Group. Switching to lanthanum carbonate monotherapy provides effective phosphate control with a low tablet burden. Nephrol Dial Transplant. 2008 Nov;23(11):3677-84. doi: 10.1093/ndt/gfn310. Epub 2008 Jun 24.
- 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 3 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 3 inclusion and 5 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 8 Jun 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in pre-dialysis serum phosphate levels at Week 3 compared with Week 5 (time frame: Week 3 and Week 5). 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 NCT00151931, which also lists 1 linked publication.
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 8 Jun 2021.