HyperphosphatemiaPhase 2NCT00769496
BAY 77-1931 Long-term Extension From Phase II Study
A Phase 2 study testing BAY 77-1931 in people with Hyperphosphatemia, run by Bayer at 14 sites in Japan.
Trial summary
A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- BAY 77-1931
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 14 sitesJapan
- Study dates
- Jan 2005to May 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing hemodialysis 3 times per week for chronic renal failure for the previous 3 consecutive months at least
Who cannot join
- Pre-dialysis serum phosphate levels of 10.0mg/dL during the washout period
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Japan14 sites
Study site
Asahikawa, Hokkaido, 070-0030
Study site
Chiba, Chiba, 261-0011
Study site
Hiroshima, Hiroshima, 730-0811
Study site
Kashiwa, Chiba, 277-0084
Study site
Kochi, Kochi, 780-0066
Study site
Kochi, Kochi, 780-8040
Study site
Kochi, Kochi, 781-5103
Study site
Narita, Chiba, 286-0041
Study site
Okayama, Okayama-ken, 701-0202
Study site
Sakura, Chiba, 285-0846
Study site
Suita, Osaka, 564-0053
Study site
Tokushima, Tokushima, 770-0011
Study site
Toyohashi, Aichi-ken, 441-8023
Study site
Yatomi, Aichi-ken, 498-0006
About this study
Official title: A Long-term, Open Label Extension, Non-controlled Study to Assess the Efficacy and Safety of BAY 77-1931 (Lanthanum Carbonate) for Hyperphosphatemia in Patients Undergoing Hemodialysis
A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis
- Conditions
- Hyperphosphatemia
- Being tested
- BAY 77-1931
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY 77-1931Drug
Lanthanum Carbonate (BAY 77-1931)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: BAY 77-1931 |
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 4 weeks
Secondary outcomes (5)
Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)
Measured: Every 4 weeks
Changes in corrected serum calcium level
Measured: Every 4 weeks
Changes in the product of serum calcium and phosphate
Measured: Every 4 weeks
Changes in serum intact-PHT levels
Measured: Every 4 weeks
Changes in bone metabolism markers
Measured: Every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startJan 2005
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769496
- Sponsor's protocol ID
- 11551
- Status last verified
- Jan 2013
- First submitted
- 8 Oct 2008
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term, Open Label Extension, Non-controlled Study to Assess the Efficacy and Safety of BAY 77-1931 (Lanthanum Carbonate) for Hyperphosphatemia in Patients Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT00769496
- Acronym / sponsor ID
- 11551
- Conditions
- Hyperphosphatemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 9 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.
A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis
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: BAY 77-1931 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing hemodialysis 3 times per week for chronic renal failure for the previous 3 consecutive months at least
Key exclusion criteria (1 listed)
- Pre-dialysis serum phosphate levels of 10.0mg/dL during the washout period
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 |
|---|---|---|
| BAY 77-1931Lanthanum Carbonate (BAY 77-1931) | Drug | Arm 1 |
Primary outcome
Changes in pre-dialysis serum phosphate levels
Time frame: Every 4 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 4 weeks
Changes in corrected serum calcium level
Time frame: Every 4 weeks
Changes in the product of serum calcium and phosphate
Time frame: Every 4 weeks
Changes in serum intact-PHT levels
Time frame: Every 4 weeks
Changes in bone metabolism markers
Time frame: Every 4 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 23 Jan 2013.
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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.
Bayer Study Director study director
Bayer
14 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 BAY 77-1931 in people with Hyperphosphatemia, run by Bayer at 14 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 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 4 weeks). 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 Jan 2013.