Kidney Failure, ChronicPhase 3NCT00150540
A Long Term Study of Lanthanum Carbonate in Patients Requiring Dialysis Who Have Ived Lanthanum Carbonate in Previous Studies Defined by the Protocol.
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 the safety of lanthanum carbonate in patients undergoing dialysis who have received lanthanum carbonate in the previous studies and wish to continue treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Lanthanum carbonate
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- 14 Oct 2002to 29 Jun 2005
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who participated in LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 and received lanthanum carbonate
- Patients must continue to require treatment with a phosphate binder for hyperphosphatemia
- male or non-pregnant female who agrees to use an effective contraceptive method while on study treatment and for 30 days thereafter
Who cannot join
- Patients withdrawn from LAM-IV-301, LAM-IV-303 OR LAM-IV-307 prior to randomization
- Patients withdrawn from LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 due to adverse events termed "possible" or "related" to study medication
- Pregnant or lactating women
About this study
Official title: A Long Term, Open Label Extension Study of Protocols LAM-IV-301, LAM-IV 303, LAM-IV 307 AND LAM-IV 308.
The purpose of this study is to assess the safety of lanthanum carbonate in patients undergoing dialysis who have received lanthanum carbonate in the previous studies and wish to continue treatment.
- 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.
Treatment emergent adverse events
Measured: Up to 24 months
Secondary outcomes (3)
Changes in pre-dialysis serum phosphate levels
Measured: Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.
Control of pre-dialysis serum phosphate levels
Measured: Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.
Plasma lanthanum levels
Measured: Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study start14 Oct 2002
- Primary completion29 Jun 2005
- Study completion29 Jun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 93 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
- NCT00150540
- Sponsor's protocol ID
- SPD405-309
- Status last verified
- Jun 2021
- First submitted
- 6 Sep 2005
- Last updated
- 23 Jun 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long Term, Open Label Extension Study of Protocols LAM-IV-301, LAM-IV 303, LAM-IV 307 AND LAM-IV 308.
- ClinicalTrials.gov ID
- NCT00150540
- Acronym / sponsor ID
- SPD405-309
- Conditions
- Kidney Failure, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2002 (actual)
- Primary completion
- 29 Jun 2005 (actual)
- Study completion
- 29 Jun 2005 (actual)
- First posted
- 8 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 the safety of lanthanum carbonate in patients undergoing dialysis who have received lanthanum carbonate in the previous studies and wish to continue treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who participated in LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 and received lanthanum carbonate
- Patients must continue to require treatment with a phosphate binder for hyperphosphatemia
- male or non-pregnant female who agrees to use an effective contraceptive method while on study treatment and for 30 days thereafter
Key exclusion criteria (3 listed)
- Patients withdrawn from LAM-IV-301, LAM-IV-303 OR LAM-IV-307 prior to randomization
- Patients withdrawn from LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 due to adverse events termed "possible" or "related" to study medication
- Pregnant or lactating women
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
Treatment emergent adverse events
Time frame: Up to 24 months
3 secondary outcomes
Changes in pre-dialysis serum phosphate levels
Time frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.
Control of pre-dialysis serum phosphate levels
Time frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.
Plasma lanthanum levels
Time frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.
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 23 Jun 2021.
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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 3 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 23 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?
Treatment emergent adverse events (time frame: Up to 24 months). 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 23 Jun 2021.