HyperphosphatemiaPhase 3NCT01514851
Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate
A Phase 3 study testing Lanthanum carbonate (BAY77-1931) and Calcium carbonate in people with Hyperphosphatemia, run by Bayer at 31 sites in Japan.
Trial summary
To assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (Lanthanum Carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized, double-blind, parallel group study in comparison with Calcium carbonate. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- Lanthanum carbonate (BAY77-1931) and Calcium carbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 31 sitesJapan
- Study dates
- Jan 2006to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-dialysis serum phosphate levels: ≧5.6 mg/dL and <11.0 mg/dL at 1 week after the initiation of the washout period.
- Out-patient
- Undergoing hemodialysis three times per week for at least previous 3 consecutive months
Who cannot join
- Pre-dialysis serum phosphate levels of ≧10.0 mg/dL at the start of the washout period or ≧11.0 mg/dL at 1 week after
- Corrected serum calcium level of <7.0 mg/dL or ≧11.0 mg/dL at the start of the washout period and/or 1 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
- Requiring treatment for hypothyroidism
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Japan31 sites
Study site
Arakawa-ku, Tokyo, 116-0003
Study site
Asahi, Chiba, 289-2511
Study site
Chiba, Chiba, 261-0011
Study site
Fuji, Shizuoka, 417-0056
Study site
Hamamatsu, Shizuoka, 430-0903
Study site
Hiroshima, Hiroshima, 730-0811
Study site
Isesaki, Gunma, 379-2211
Study site
Kashiwa, Chiba, 277-0084
Study site
Kobe, Hyōgo, 658-0084
Study site
Kochi, Kochi, 780-0066
Study site
Kodaira, Tokyo, 187-0001
Study site
Kurume, Fukuoka, 830-8522
Study site
Kurume, Fukuoka, 830-8543
Study site
Matsudo, Chiba, 271-0077
Study site
Mito, Ibaraki, 310-0844
Study site
Narita, Chiba, 286-0041
Study site
Nerima-ku, Tokyo, 176-0023
Study site
Okayama, Okayama-ken, 701-0202
Study site
Ōsaki, Miyagi, 989-6117
Study site
Saitama, Saitama, 330-0854
Study site
Saitama, Saitama, 330-0856
Study site
Saitama, Saitama, 337-0043
Study site
Sendai, Miyagi, 981-0912
Study site
Shibuya-ku, Tokyo, 151-0053
Study site
Shinjyuku-ku, Tokyo, 160-0023
Study site
Suita, Osaka, 564-0053
Study site
Takamatsu, Kagawa-ken, 761-8024
Study site
Tokushima, Tokushima, 770-0011
Study site
Toyohashi, Aichi-ken, 441-8023
Study site
Tsuchiura, Ibaraki, 300-0053
Study site
Yatomi, Aichi-ken, 498-0006
About this study
Official title: Phase III Double-blind Comparative Study of BAY 77 1931 (Lanthanum Carbonate) With a Calcium Carbonate in Patients With Hyperphosphatemia Undergoing Hemodialysis
To assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (Lanthanum Carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized, double-blind, parallel group study in comparison with Calcium carbonate.
- Conditions
- Hyperphosphatemia
- Being tested
- Lanthanum carbonate (BAY77-1931), Calcium carbonate
- 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
Calcium carbonateDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 750-2250mg/day, tid (three times a day), 8 weeks Receives: Drug: Lanthanum carbonate (BAY77-1931) |
| Arm 2 | Active comparator | 1500-4500mg/day, tid, 8 weeks Receives: Drug: Calcium carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind period
Measured: baseline to week 8
Presence/absence of incidence of hypercalcemia up to 8 weeks
Measured: up to 8 weeks
Secondary outcomes (6)
Number of participants achieving target PSPL and time to achievement
Measured: up to 8 weeks
Serum calcium x phosphate product at the end of the double-blind treatment period
Measured: Week 8
Serum intact-PTH (Parathyroid) levels
Measured: Week 8
Serum calcium level corrected by serum albumin level at the end of the double-blind treatment period
Measured: Week 8
Number of participants achieving the target serum calcium levels
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 posted23 Jan 2012 (estimated)
- Study startJan 2006
- Primary completionMay 2006
- Study completionMay 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 259 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
- NCT01514851
- Sponsor's protocol ID
- 11877
- Status last verified
- Jun 2012
- First submitted
- 18 Jan 2012
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Double-blind Comparative Study of BAY 77 1931 (Lanthanum Carbonate) With a Calcium Carbonate in Patients With Hyperphosphatemia Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT01514851
- Acronym / sponsor ID
- 11877
- Conditions
- Hyperphosphatemia
- Keywords
- Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 23 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.
To assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (Lanthanum Carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized, double-blind, parallel group study in comparison with Calcium carbonate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Lanthanum carbonate (BAY77-1931)750-2250mg/day, tid (three times a day), 8 weeks |
| Arm 2 | Active comparator | Drug: Calcium carbonate1500-4500mg/day, tid, 8 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pre-dialysis serum phosphate levels: ≧5.6 mg/dL and <11.0 mg/dL at 1 week after the initiation of the washout period.
- Out-patient
- Undergoing hemodialysis three times per week for at least previous 3 consecutive months
Key exclusion criteria (8 listed)
- Pre-dialysis serum phosphate levels of ≧10.0 mg/dL at the start of the washout period or ≧11.0 mg/dL at 1 week after
- Corrected serum calcium level of <7.0 mg/dL or ≧11.0 mg/dL at the start of the washout period and/or 1 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
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 |
| Calcium carbonate | Drug | Arm 2 |
Primary outcome
Change from baseline in pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind period
Time frame: baseline to week 8
Presence/absence of incidence of hypercalcemia up to 8 weeks
Time frame: up to 8 weeks
6 secondary outcomes
Number of participants achieving target PSPL and time to achievement
Time frame: up to 8 weeks
Serum calcium x phosphate product at the end of the double-blind treatment period
Time frame: Week 8
Serum intact-PTH (Parathyroid) levels
Time frame: Week 8
Serum calcium level corrected by serum albumin level at the end of the double-blind treatment period
Time frame: Week 8
Number of participants achieving the target serum calcium levels
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 8 Jun 2012.
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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
31 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) and Calcium carbonate in people with Hyperphosphatemia, run by Bayer at 31 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 8 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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 pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind period (time frame: baseline to week 8). The study lists 2 primary outcomes in all. 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 8 Jun 2012.