HyperphosphatemiaPhase 2NCT00767637
Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone
A Phase 2 study testing Lanthanum Carbonate (BAY77-1931) in people with Hyperphosphatemia and Dialysis, run by Bayer at 2 sites in Japan.
Trial summary
To measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving dialysis Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hyperphosphatemia, Dialysis
- What is being tested?
- Lanthanum Carbonate (BAY77-1931)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesJapan
- Study dates
- Jun 2005to Oct 2008
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing dialysis or plan to start dialysis before the initial administration of the study medication
Who cannot join
- Patients with severe hypocalcemia (adjusted serum calcium level of <7.5 mg/dL)
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Study site
Isesaki, Gunma, 379-2211
Study site
Yonago, Tottori, 683-0002
About this study
Official title: Open Label, Non-controlled Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone in Patients With Hyperphosphatemia Receiving Dialysis
To measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving dialysis
- Conditions
- Hyperphosphatemia, Dialysis
- Being tested
- Lanthanum Carbonate (BAY77-1931)
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanthanum Carbonate (BAY77-1931)Drug
BAY77-1931 750mg, in the morning, day and evening
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Lanthanum Carbonate (BAY77-1931) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pre-dialysis serum phosphate levels
Measured: Every 2 weeks
Secondary outcomes (5)
Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)
Measured: Every 2 weeks
Changes in corrected serum calcium level
Measured: Every 2 weeks
Changes in the product of serum calcium and phosphate
Measured: Every 2 weeks
Changes in serum intact-PHT levels
Measured: Every 2 weeks
Changes in bone metabolism markers
Measured: Every 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startJun 2005
- Primary completionOct 2008
- Study completionOct 2008
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 HyperphosphatemiaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767637
- Sponsor's protocol ID
- 11810
- Other IDs
- Fosrenol
- Status last verified
- Jun 2014
- First submitted
- 6 Oct 2008
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Shigematsu T, Tokumoto A, Nakaoka A, Arisaka H. Effect of lanthanum carbonate treatment on bone in Japanese dialysis patients with hyperphosphatemia. Ther Apher Dial. 2011 Apr;15(2):176-84. doi: 10.1111/j.1744-9987.2010.00898.x.
PubMed 21426511
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Non-controlled Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone in Patients With Hyperphosphatemia Receiving Dialysis
- ClinicalTrials.gov ID
- NCT00767637
- Acronym / sponsor ID
- 11810
- Conditions
- Hyperphosphatemia, Dialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 7 Oct 2008 (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.
To measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving dialysis
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Lanthanum Carbonate (BAY77-1931) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing dialysis or plan to start dialysis before the initial administration of the study medication
Key exclusion criteria (1 listed)
- Patients with severe hypocalcemia (adjusted serum calcium level of <7.5 mg/dL)
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 (BAY77-1931)BAY77-1931 750mg, in the morning, day and evening | Drug | Arm 1 |
Primary outcome
Changes in pre-dialysis serum phosphate levels
Time frame: Every 2 weeks
5 secondary outcomes
Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)
Time frame: Every 2 weeks
Changes in corrected serum calcium level
Time frame: Every 2 weeks
Changes in the product of serum calcium and phosphate
Time frame: Every 2 weeks
Changes in serum intact-PHT levels
Time frame: Every 2 weeks
Changes in bone metabolism markers
Time frame: Every 2 weeks
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 20 Jun 2014.
- Derived from this study: PubMed 21426511Shigematsu T, Tokumoto A, Nakaoka A, Arisaka H. Effect of lanthanum carbonate treatment on bone in Japanese dialysis patients with hyperphosphatemia. Ther Apher Dial. 2011 Apr;15(2):176-84. doi: 10.1111/j.1744-9987.2010.00898.x.
Related trials for Hyperphosphatemia
Not yet recruitingObservational study
Tenapanor in Maintenance Hemodialysis Patients
Hyperphosphatemia, Maintenance Hemodialysis
Active, not recruitingPhase 3
A Clinical Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
Hyperphosphatemia Patients on Hemodialysis
RecruitingObservational study
Multicenter, Open, Prospective, 48 Weeks, Observational Study ,Evaluate the Safety and Efficacy of Nephoxil Capsule
Hyperphosphatemia
Recruiting
Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)
Kidney Failure, Chronic, Hyperphosphatemia
RecruitingPhase 2
Phosphate in Acute Pancreatitis
Pancreatitis
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.
Bayer Study Director study director
Bayer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lanthanum Carbonate (BAY77-1931) in people with Hyperphosphatemia and Dialysis, run by Bayer at 2 sites in Japan.
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 1 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 20 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes in pre-dialysis serum phosphate levels (time frame: Every 2 weeks). 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 NCT00767637, 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 20 Jun 2014.