HyperphosphatemiaPhase 3NCT01187628
Long-term Study in Chronic Kidney Disease (Extension From Study 14817)
A Phase 3 study testing Fosrenol (Lanthanum Carbonate, BAY77-1931) in people with Hyperphosphatemia, run by Bayer at 40 sites in Japan.
Trial summary
The objective of this study is to investigate the safety and the effect on reduction of serum phosphate of long-term administration of lanthanum carbonate (BAY77-1931) 750 to 2250 mg in patients with hyperphosphatemia who completed the 8 week double-blind treatment period of Study 14817 and are judged to be eligible… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- Fosrenol (Lanthanum Carbonate, BAY77-1931)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 40 sitesJapan
- Study dates
- Sep 2010to Apr 2013
- 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
- Patients who have completed the 8-week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study by the investigator (including those who plan to be on dialysis during the long-term extension study).
Who cannot join
- Patients with any other conditions that the investigator defines as not appropriate to be enrolled in the study
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Japan40 sites
Study site
Amagasaki, Hyōgo, 660-0828
Study site
Anjo, Aichi-ken, 446-8602
Study site
Beppu, Oita Prefecture, 874-0011
Study site
Fujisawa, Kanagawa, 251-8550
Study site
Fukuoka, Fukuoka, 810-8563
Study site
Fukuoka, Fukuoka, 814-0180
Study site
Kamakura, Kanagawa, 247-8533
Study site
Kamogawa, Chiba, 296-0041
Study site
Kisarazu, Chiba, 292-8535
Study site
Kitakyushu, Fukuoka, 802-0001
Study site
Kitakyushu, Fukuoka, 805-0050
Study site
Koga, Fukuoka, 811-3195
Study site
Koto, Tokyo, 136-0075
Study site
Kurashiki, Okayama-ken, 710-8602
Study site
Kyoto, Kyoto, 612-8555
Study site
Meguro-ku, Tokyo, 152-8902
Study site
Minato-ku, Tokyo, 105-8471
Study site
Musashino, Tokyo, 180-8610
Study site
Nagoya, Aichi-ken, 455-8530
Study site
Nagoya, Aichi-ken, 457-8510
Study site
Nagoya, Aichi-ken, 460-0001
Study site
Nagoya, Aichi-ken, 466-8650
Study site
Ōita, Oita Prefecture, 870-0263
Study site
Okayama, Okayama-ken, 700-0013
Study site
Osaka, Osaka, 530-0012
Study site
Osaka, Osaka, 530-8480
Study site
Osaka, Osaka, 534-0021
Study site
Osaka, Osaka, 558-8558
Study site
Saga, Saga-ken, 840-0054
Study site
Sakai, Osaka, 591-8025
Study site
Sapporo, Hokkaido, 063-0005
Study site
Seto, Aichi-ken, 489-8642
Study site
Shinagawa, Tokyo, 141-8625
Study site
Shizuoka, Shizuoka, 421-0193
Study site
Tokushima, Tokushima, 770-0011
Study site
Toyohashi, Aichi-ken, 441-8021
Study site
Wakayama, Wakayama, 641-8510
Study site
Yatomi, Aichi-ken, 498-8502
Study site
Yokohama, Kanagawa, 231-8682
Study site
Yokohama, Kanagawa, 234-8503
About this study
Official title: An Open-label, Long-term Extension Study of Lanthanum Carbonate 750 to 2,250 mg in Hyperphosphatemia in Patients With Chronic Kidney Disease Not on Dialysis (52 Weeks Extension From Study 14817)
The objective of this study is to investigate the safety and the effect on reduction of serum phosphate of long-term administration of lanthanum carbonate (BAY77-1931) 750 to 2250 mg in patients with hyperphosphatemia who completed the 8 week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study.
- Conditions
- Hyperphosphatemia
- Being tested
- Fosrenol (Lanthanum Carbonate, BAY77-1931)
- Keywords
- Long-term study in Chronic Kidney Disease, Lanthanum Carbonate
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosrenol (Lanthanum Carbonate, BAY77-1931)Drug
Daily dose: 750-2250mg/day,(270-750mg each 3 times a day) for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events
Measured: baseline to Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2013
- Study completionApr 2013
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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shire
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187628
- Sponsor's protocol ID
- 15074
- Status last verified
- Apr 2015
- First submitted
- 23 Aug 2010
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Long-term Extension Study of Lanthanum Carbonate 750 to 2,250 mg in Hyperphosphatemia in Patients With Chronic Kidney Disease Not on Dialysis (52 Weeks Extension From Study 14817)
- ClinicalTrials.gov ID
- NCT01187628
- Acronym / sponsor ID
- 15074
- Conditions
- Hyperphosphatemia
- Keywords
- Long-term study in Chronic Kidney Disease, Lanthanum Carbonate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Shire
- Study start
- Sep 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 Aug 2010 (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 objective of this study is to investigate the safety and the effect on reduction of serum phosphate of long-term administration of lanthanum carbonate (BAY77-1931) 750 to 2250 mg in patients with hyperphosphatemia who completed the 8 week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study.
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: Fosrenol (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 who have completed the 8-week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study by the investigator (including those who plan to be on dialysis during the long-term extension study).
Key exclusion criteria (1 listed)
- Patients with any other conditions that the investigator defines as not appropriate to be enrolled in the study
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 |
|---|---|---|
| Fosrenol (Lanthanum Carbonate, BAY77-1931)Daily dose: 750-2250mg/day,(270-750mg each 3 times a day) for 52 weeks. | Drug | Arm 1 |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: baseline to Week 60
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 3 Apr 2015.
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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
40 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 Fosrenol (Lanthanum Carbonate, BAY77-1931) in people with Hyperphosphatemia, run by Bayer at 40 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 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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?
Incidence of treatment emergent adverse events (time frame: baseline to Week 60). 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 3 Apr 2015.