HyperphosphatemiaFOSRENOL-CAPDNCT01412398
Fosrenol Post-marketing Surveillance for Continuous Cyclic Peritoneal Dialysis in Japan
An observational study of Hyperphosphatemia, run by Bayer at 1 site in Japan.
Trial summary
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in continuous ambulatory peritoneal dialysis (CAPD) who have received Fosrenol for hyperphosphatemia. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 446 participants
- Where
- 1 siteJapan
- Study dates
- 7 Apr 2009to 1 Sep 2016
- Phase
- Observational
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study is all case investigation of which the enrollment period is one year, and all patients in CAPD who received Fosrenol for hyperphosphatemia will be recruited.
Who may be able to join
- Patients undergoing continuous ambulatory peritoneal dialysis who received Fosrenol for hyperphosphatemia
Who cannot join
- Patients who are contraindicated based on the product label
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Special Drug Use Investigation of Fosrenol (Investigation for Patients With Continuous Ambulatory Peritoneal Dialysis)
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in continuous ambulatory peritoneal dialysis (CAPD) who have received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. This study is also all case investigation of which the enrollment period is one year, and all patients in CAPD who received Fosrenol for hyperphosphatemia will be recruited and followed one year.
- Conditions
- Hyperphosphatemia
- Being tested
- Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet
- Keywords
- Fosrenol, Hyperphosphatemia, Continuous Cyclic Peritoneal Dialysis
- 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 (Fosrenol, BAY77-1931) - chewable tabletDrug
Patients in CAPD who have received Fosrenol for hyperphosphatemia
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Drug (incl. Placebo) Receives: Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse drug reactions in subjects who received Fosrenol
Measured: After Fosrenol administration, up to 1 year
Incidence of serious adverse events in subjects who received Fosrenol
Measured: After Fosrenol administration, up to 1 year
Secondary outcomes (4)
Incidence of adverse drug reactions in subpopulation with baseline data [such as demographic data, concomitant disease, duration of treatment, maximum daily dose] and dose of Fosrenol
Measured: After Fosrenol administration, up to 1 year
Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL]
Measured: After Fosrenol administration, up to 1 year
Effectiveness evaluation assessment [achievement rate of a goal calcium level; 8.4-10.0 mg/dL]
Measured: After Fosrenol administration, up to 1 year
Clinical test value collections [calciotropic hormones, bone turnover markers]
Measured: After Fosrenol administration, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study start7 Apr 2009
- Primary completion8 Apr 2014
- Study completion1 Sep 2016
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 446 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
- NCT01412398
- Sponsor's protocol ID
- 15076
- Acronym
- FOSRENOL-CAPD
- Status last verified
- Jan 2018
- First submitted
- 4 Aug 2011
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation of Fosrenol (Investigation for Patients With Continuous Ambulatory Peritoneal Dialysis)
- ClinicalTrials.gov ID
- NCT01412398
- Acronym / sponsor ID
- FOSRENOL-CAPD / 15076
- Conditions
- Hyperphosphatemia
- Keywords
- Fosrenol, Hyperphosphatemia, Continuous Cyclic Peritoneal Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2009 (actual)
- Primary completion
- 8 Apr 2014 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 9 Aug 2011 (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.
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in continuous ambulatory peritoneal dialysis (CAPD) who have received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. This study is also all case investigation of which the enrollment period is one year, and all patients in CAPD who received Fosrenol for hyperphosphatemia will be recruited and followed one year.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tabletDrug (incl. Placebo) |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study is all case investigation of which the enrollment period is one year, and all patients in CAPD who received Fosrenol for hyperphosphatemia will be recruited.
Key inclusion criteria (1 listed)
- Patients undergoing continuous ambulatory peritoneal dialysis who received Fosrenol for hyperphosphatemia
Key exclusion criteria (1 listed)
- Patients who are contraindicated based on the product label
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 (Fosrenol, BAY77-1931) - chewable tabletPatients in CAPD who have received Fosrenol for hyperphosphatemia | Drug | Group 1 |
Primary outcome
Incidence of adverse drug reactions in subjects who received Fosrenol
Time frame: After Fosrenol administration, up to 1 year
Incidence of serious adverse events in subjects who received Fosrenol
Time frame: After Fosrenol administration, up to 1 year
4 secondary outcomes
Incidence of adverse drug reactions in subpopulation with baseline data [such as demographic data, concomitant disease, duration of treatment, maximum daily dose] and dose of Fosrenol
Time frame: After Fosrenol administration, up to 1 year
Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL]
Time frame: After Fosrenol administration, up to 1 year
Effectiveness evaluation assessment [achievement rate of a goal calcium level; 8.4-10.0 mg/dL]
Time frame: After Fosrenol administration, up to 1 year
Clinical test value collections [calciotropic hormones, bone turnover markers]
Time frame: After Fosrenol administration, up to 1 year
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 19 Jan 2018.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperphosphatemia, run by Bayer at 1 site 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 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 adverse drug reactions in subjects who received Fosrenol (time frame: After Fosrenol administration, up to 1 year). 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 19 Jan 2018; AzTrials last refreshed its copy on 7 Nov 2026.