HyperphosphatemiaFOSRENOL-HDNCT01419327
Fosrenol Post-marketing Surveillance for Hemodialysis 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 hemodialysis who received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. Read more about this study
- Who is it for?
- Any age
- 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
- 3,267 participants
- Where
- 1 siteJapan
- Study dates
- 23 Mar 2009to 28 May 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The target population of this study is patients who have received a prescription of Fosrenol on the basis of the decision of the physician. The study is expected to collect data of 3,000 patients in about 300 practices in Japan.
Who may be able to join
- Patients undergoing hemodialysis 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 (Long-term Investigation for Patients With Hemodialysis)
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in hemodialysis who received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. A total 3,000 patients will be recruited and followed 5 years.
- Conditions
- Hyperphosphatemia
- Being tested
- Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet
- Keywords
- Fosrenol, Hyperphosphatemia, Hemodialysis
- 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 hemodialysis 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 8 years
Secondary outcomes (7)
Timing of onset of common ADRs related to the priority survey items
The items are
- Gastrointestinal symptoms
- Secondary hyperparathyroidism
- Hypocalcaemia and decreased blood calcium
Measured: After Fosrenol administration, up to 8 years
Effect on bones: Alkaline phosphatase over time
Measured: After Fosrenol administration, up to 8 years
Effect on bones: Change in bone density
Measured: After Fosrenol administration, up to 8 years
Cardiothoracic ratio over time
Measured: After Fosrenol administration, up to 8 years
PWV and ABI over time
Measured: After Fosrenol administration, up to 8 years
Serum P, albumin-corrected serum Ca and serum intact PTH, and Ca-P product over time
Measured: After Fosrenol administration, up to 8 years
Percentage of patients achieving the serum P control goal
Measured: After Fosrenol administration, up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study start23 Mar 2009
- Primary completion30 Jan 2019
- Study completion28 May 2019
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
- 3,267 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
- NCT01419327
- Sponsor's protocol ID
- 15077
- Acronym
- FOSRENOL-HD
- Status last verified
- May 2020
- First submitted
- 17 Aug 2011
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation of Fosrenol (Long-term Investigation for Patients With Hemodialysis)
- ClinicalTrials.gov ID
- NCT01419327
- Acronym / sponsor ID
- FOSRENOL-HD / 15077
- Conditions
- Hyperphosphatemia
- Keywords
- Fosrenol, Hyperphosphatemia, Hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,267 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2009 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 18 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 hemodialysis who received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. A total 3,000 patients will be recruited and followed 5 years.
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
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target population of this study is patients who have received a prescription of Fosrenol on the basis of the decision of the physician. The study is expected to collect data of 3,000 patients in about 300 practices in Japan.
Key inclusion criteria (1 listed)
- Patients undergoing hemodialysis 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 hemodialysis 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 8 years
7 secondary outcomes
Timing of onset of common ADRs related to the priority survey items
Time frame: After Fosrenol administration, up to 8 years
Effect on bones: Alkaline phosphatase over time
Time frame: After Fosrenol administration, up to 8 years
Effect on bones: Change in bone density
Time frame: After Fosrenol administration, up to 8 years
Cardiothoracic ratio over time
Time frame: After Fosrenol administration, up to 8 years
PWV and ABI over time
Time frame: After Fosrenol administration, up to 8 years
Serum P, albumin-corrected serum Ca and serum intact PTH, and Ca-P product over time
Time frame: After Fosrenol administration, up to 8 years
Percentage of patients achieving the serum P control goal
Time frame: After Fosrenol administration, up to 8 years
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 20 May 2020.
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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 20 May 2020. 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 8 years). 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 20 May 2020; AzTrials last refreshed its copy on 8 Nov 2026.