Kidney Failure, ChronicPhase 3NCT00151918
Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease
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 either lanthanum carbonate or sevelamer hydrochloride 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
- 48 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2005to 22 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving haemodialysis for ESRD
- Patients must have received haemodialysis for chronic renal failure three times per week for at least the previous 2 months
Who cannot join
- Pregnant or lactating women
- Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma
- Patients who are HIV+
- Patients with any significant bowel obstruction, active inflammatory bowel disease, GI motility disorders, or a history of major GI surgery within the last 6 months
About this study
Official title: A Multi-Centre, Open Label, Randomized, Parallel Group Pilot Study to Assess the Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease
The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with either lanthanum carbonate or sevelamer hydrochloride
- 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.
Mean pre-dialysis serum phosphate level
Measured: The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)
Secondary outcomes (4)
Mean pre-dialysis serum calcium product
Measured: The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)
Mean pre-dialysis calcium-phosphate product
Measured: The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)
Average daily pill burden
Measured: Daily throughout for the 8 week Evaluation for Dose Adjustment Period up to the End of Study/ Withdrawal Visit.
Treatment emergent adverse events
Treatment-emergent adverse events (TEAEs) were defined as AEs that had an onset date and time on or after the date and time of the first dose of study medication.
Measured: Throughout the study period of approximately 7.5 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 start7 Jan 2005
- Primary completion22 Aug 2005
- Study completion22 Aug 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT00151918
- Sponsor's protocol ID
- SPD405-310
- Other IDs
- 2004-001608-11, 2004
- Status last verified
- Jul 2021
- First submitted
- 7 Sep 2005
- Last updated
- 6 Jul 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Open Label, Randomized, Parallel Group Pilot Study to Assess the Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease
- ClinicalTrials.gov ID
- NCT00151918
- Acronym / sponsor ID
- SPD405-310
- Conditions
- Kidney Failure, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2005 (actual)
- Primary completion
- 22 Aug 2005 (actual)
- Study completion
- 22 Aug 2005 (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 either lanthanum carbonate or sevelamer hydrochloride
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (2 listed)
- Patients receiving haemodialysis for ESRD
- Patients must have received haemodialysis for chronic renal failure three times per week for at least the previous 2 months
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma
- Patients who are HIV+
- Patients with any significant bowel obstruction, active inflammatory bowel disease, GI motility disorders, or a history of major GI surgery within the last 6 months
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
Mean pre-dialysis serum phosphate level
Time frame: The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)
4 secondary outcomes
Mean pre-dialysis serum calcium product
Time frame: The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)
Mean pre-dialysis calcium-phosphate product
Time frame: The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)
Average daily pill burden
Time frame: Daily throughout for the 8 week Evaluation for Dose Adjustment Period up to the End of Study/ Withdrawal Visit.
Treatment emergent adverse events
Time frame: Throughout the study period of approximately 7.5 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 6 Jul 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 2 inclusion and 4 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 6 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 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?
Mean pre-dialysis serum phosphate level (time frame: The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)). 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 6 Jul 2021.