HyperphosphatemiaPhase 3NCT01518387
Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients
A Phase 3 study testing Lanthanum Carbonate (BAY77-1931) in people with Hyperphosphatemia, run by Bayer at 11 sites in Japan.
Trial summary
The purpose of this study is to assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- Lanthanum Carbonate (BAY77-1931)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 11 sitesJapan
- Study dates
- Jan 2006to Jul 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serum phosphate levels: >5.0 mg/dL and <11.0 mg/dL 2 weeks after the initiation of the washout period
- Out-patient
- Undergoing CAPD for at least previous 3 consecutive months
Who cannot join
- Who may not enable to continue CAPD
- Serum phosphate levels of >=10.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 week after
- Corrected serum calcium level of <7.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 week after
- Serum intact PTH (Parathyroid) of >=1000 pg/mL at the start of the washout period
- Pregnant woman, or lactating mother
- Significant gastrointestinal disorders including known acute peptic ulcer
- Liver dysfunction
- History of cardiovascular or cerebrovascular diseases
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Japan11 sites
Study site
Asahikawa, Hokkaido, 070-0030
Study site
Fukuoka, Fukuoka, 815-0082
Study site
Gifu, Gifu, 500-8717
Study site
Hiroshima, Hiroshima, 730-8655
Study site
Kamakura, Kanagawa, 247-0072
Study site
Meguro-ku, Tokyo, 153-0061
Study site
Okayama, Okayama-ken, 700-0013
Study site
Ōsaki, Miyagi, 989-6117
Study site
Sendai, Miyagi, 981-0912
Study site
Tokushima, Tokushima, 770-0011
Study site
Yokosuka, Kanagawa, 238-0011
About this study
Official title: Phase III Open Study of BAY 77 1931 (Lanthanum Carbonate) in Patients With Hyperphosphatemia Undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD)
The purpose of this study is to assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis.
- Conditions
- Hyperphosphatemia
- Being tested
- Lanthanum Carbonate (BAY77-1931)
- Keywords
- Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis
- Medical subject headings
- Hyperphosphatemia, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanthanum Carbonate (BAY77-1931)Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 750-2250mg/day, tid, 8 weeks Receives: Drug: Lanthanum Carbonate (BAY77-1931) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in serum phosphate levels at the end of the treatment period
Measured: Baseline to Week 8
Secondary outcomes (5)
Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievement
Measured: Week 8
Serum calcium level corrected by serum albumin level at the end of the treatment period
Measured: Week 8
Serum calcium x phosphate product at the end of the treatment period
Measured: Week 8
Serum intact-PTH (Parathyroid) levels at the end of the treatment period
Measured: Week 8
Safety variables will be summarized using descriptive statistics based on adverse events collection
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startJan 2006
- Primary completionJul 2006
- Study completionJul 2006
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 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
- NCT01518387
- Sponsor's protocol ID
- 11878
- Status last verified
- Mar 2016
- First submitted
- 18 Jan 2012
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Open Study of BAY 77 1931 (Lanthanum Carbonate) in Patients With Hyperphosphatemia Undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD)
- ClinicalTrials.gov ID
- NCT01518387
- Acronym / sponsor ID
- 11878
- Conditions
- Hyperphosphatemia
- Keywords
- Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 26 Jan 2012 (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 effect on reduction of serum phosphate and the safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Lanthanum Carbonate (BAY77-1931)750-2250mg/day, tid, 8 weeks |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Serum phosphate levels: >5.0 mg/dL and <11.0 mg/dL 2 weeks after the initiation of the washout period
- Out-patient
- Undergoing CAPD for at least previous 3 consecutive months
Key exclusion criteria (8 listed)
- Who may not enable to continue CAPD
- Serum phosphate levels of >=10.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 week after
- Corrected serum calcium level of <7.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 week after
- Serum intact PTH (Parathyroid) of >=1000 pg/mL at the start of the washout period
- Pregnant woman, or lactating mother
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) | Drug | Arm 1 |
Primary outcome
Change from baseline in serum phosphate levels at the end of the treatment period
Time frame: Baseline to Week 8
5 secondary outcomes
Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievement
Time frame: Week 8
Serum calcium level corrected by serum albumin level at the end of the treatment period
Time frame: Week 8
Serum calcium x phosphate product at the end of the treatment period
Time frame: Week 8
Serum intact-PTH (Parathyroid) levels at the end of the treatment period
Time frame: Week 8
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time frame: 8 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 14 Mar 2016.
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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
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lanthanum Carbonate (BAY77-1931) in people with Hyperphosphatemia, run by Bayer at 11 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 3 inclusion and 8 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 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 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 from baseline in serum phosphate levels at the end of the treatment period (time frame: Baseline to Week 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 14 Mar 2016.