HyperphosphatemiaNCT01955876
Fosrenol Post-marketing Surveillance in Japan
An observational study of Hyperphosphatemia and Kidney Disease, 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 who have received Fosrenol. The objective of this research is to collect information on the safety of Fosrenol after its launching, which means collecting information on adverse events… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperphosphatemia, Kidney Disease
- What is being tested?
- Lanthanum Carbonate (Fosrenol, BAY77-1931)
- How many people
- 343 participants
- Where
- 1 siteJapan
- Study dates
- 10 Oct 2013to 5 Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chronic renal failure patients who have not been treated with dialysis and will be treated with Fosrenol for hyperphosphatemia
Who may be able to join
- Patients whom investigators have decided to treat with Lanthanum carbonate for the first time at the respective medical institutions. Those medical institutions have to understand the objective of this investigation and conclude a written contract with Bayer Yakuhin.
- The decision to treat patients with Lanthanum carbonate will be made independently by the investigator prior to study inclusion.
- Patients treated with Lanthanum carbonate in the indication "Hyperphosphatemia" with chronic kidney disease not on dialysis".
Who cannot join
- Patients who are contraindicated based on the product label.
- Patients who have been already treated with Fosrenol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Use Investigation of Fosrenol for Hyperphosphatemia With Chronic Kidney Disease Not on Dialysis
This study is a regulatory post-marketing surveillance in Japan and it is a local prospective and observational study of patients who have received Fosrenol.
The objective of this research is to collect information on the safety of Fosrenol after its launching, which means collecting information on adverse events, especially adverse events in the digestive system including constipation and serious adverse events, and adverse drug reactions when the drug is administered to the below-mentioned target patients for six months.
The secondary objective is to collect information on the safety of the drug when administered for more than six months, which means collecting information on the safety of the drug when administered for up to 12 months to the target patients who have already been treated with the drug for six months. And also if at the time of 12 months after administration of Lanthanum carbonate the dialysis is not conducted, extending its' administration will be continued until conduction of dialysis, or until Sept. 30, 2015. The efficacy of fosrenol is evaluated by observing the serum P(phosphorus) level and serum PTH (parathyroid hormone) level change.
- Conditions
- Hyperphosphatemia, Kidney Disease
- Being tested
- Lanthanum Carbonate (Fosrenol, BAY77-1931)
- Keywords
- Fosrenol, hyperphosphatemia, chronic kidney disease not on dialysis
- Medical subject headings
- Hyperphosphatemia, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanthanum Carbonate (Fosrenol, BAY77-1931)Drug
Patients treated with Fosrenol in daily clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence/number of episodes of adverse drug reactions and adverse events
Measured: 6 months after start of treatment with the drug
Secondary outcomes (10)
Incidence/number of episodes of adverse drug reactions and adverse events
Measured: until the conduction of dialysis after starting the treatment with Lanthanum carbonate(Maximum 2 years)
Adverse drug event rate related to the digestive system
Measured: until the conduction of dialysis(Maximum 2 years)
Incidence/number of episodes of adverse events for 6, 12 months ,and from month 13 to the conduction of dialysis after starting the treatment with Lanthanum carbonate.
Measured: until the conduction of dialysis(Maximum 2 years)
Incidence/number of episodes of adverse drug reactions for 6, 12 months ,and from month 13 to the conduction of dialysis after starting the treatment with Lanthanum carbonate according to patient characteristics and treatment with Lanthanum carbonate.
Measured: until the conduction of dialysis(Maximum 2 years)
Serum P level for six months after start of treatment with the drug in comparison with baseline (at the time of start of treatment with fosrenol)
Measured: 6 months after start of treatment with the drug
Serum intact PTH level for six months after start of treatment with the drug in comparison with baseline
Measured: 6 months after start of treatment with the drug
Serum P level at 12 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Fosrenol).
Measured: 12 months
Serum P level at the conduction of dialysis from 13 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Fosrenol).
Measured: until the conduction of dialysis(Maximum 2 years)
Serum intact PTH level at 12 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Lanthanum carbonate).
Measured: 12 months
Serum intact PTH level at the conduction of dialysis from 13 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Lanthanum carbonate).
Measured: until the conduction of dialysis(Maximum 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study start10 Oct 2013
- Primary completion18 Feb 2016
- Study completion5 Aug 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
- 343 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
- NCT01955876
- Sponsor's protocol ID
- 16626
- Other IDs
- FOSRENOL-PRED
- Status last verified
- Feb 2018
- First submitted
- 6 Sep 2013
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation of Fosrenol for Hyperphosphatemia With Chronic Kidney Disease Not on Dialysis
- ClinicalTrials.gov ID
- NCT01955876
- Acronym / sponsor ID
- 16626
- Conditions
- Hyperphosphatemia, Kidney Disease
- Keywords
- Fosrenol, hyperphosphatemia, chronic kidney disease not on dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2013 (actual)
- Primary completion
- 18 Feb 2016 (actual)
- Study completion
- 5 Aug 2016 (actual)
- First posted
- 8 Oct 2013 (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 who have received Fosrenol.
The objective of this research is to collect information on the safety of Fosrenol after its launching, which means collecting information on adverse events, especially adverse events in the digestive system including constipation and serious adverse events, and adverse drug reactions when the drug is administered to the below-mentioned target patients for six months.
The secondary objective is to collect information on the safety of the drug when administered for more than six months, which means collecting information on the safety of the drug when administered for up to 12 months to the target patients who have already been treated with the drug for six months. And also if at the time of 12 months after administration of Lanthanum carbonate the dialysis is not conducted, extending its' administration will be continued until conduction of dialysis, or until Sept. 30, 2015. The efficacy of fosrenol is evaluated by observing the serum P(phosphorus) level and serum PTH (parathyroid hormone) level change.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chronic renal failure patients who have not been treated with dialysis and will be treated with Fosrenol for hyperphosphatemia
Key inclusion criteria (3 listed)
- Patients whom investigators have decided to treat with Lanthanum carbonate for the first time at the respective medical institutions. Those medical institutions have to understand the objective of this investigation and conclude a written contract with Bayer Yakuhin.
- The decision to treat patients with Lanthanum carbonate will be made independently by the investigator prior to study inclusion.
- Patients treated with Lanthanum carbonate in the indication "Hyperphosphatemia" with chronic kidney disease not on dialysis".
Key exclusion criteria (2 listed)
- Patients who are contraindicated based on the product label.
- Patients who have been already treated with Fosrenol
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)Patients treated with Fosrenol in daily clinical practice. | Drug | Group 1 |
Primary outcome
Incidence/number of episodes of adverse drug reactions and adverse events
Time frame: 6 months after start of treatment with the drug
10 secondary outcomes
Incidence/number of episodes of adverse drug reactions and adverse events
Time frame: until the conduction of dialysis after starting the treatment with Lanthanum carbonate(Maximum 2 years)
Adverse drug event rate related to the digestive system
Time frame: until the conduction of dialysis(Maximum 2 years)
Incidence/number of episodes of adverse events for 6, 12 months ,and from month 13 to the conduction of dialysis after starting the treatment with Lanthanum carbonate.
Time frame: until the conduction of dialysis(Maximum 2 years)
Incidence/number of episodes of adverse drug reactions for 6, 12 months ,and from month 13 to the conduction of dialysis after starting the treatment with Lanthanum carbonate according to patient characteristics and treatment with Lanthanum carbonate.
Time frame: until the conduction of dialysis(Maximum 2 years)
Serum P level for six months after start of treatment with the drug in comparison with baseline (at the time of start of treatment with fosrenol)
Time frame: 6 months after start of treatment with the drug
Serum intact PTH level for six months after start of treatment with the drug in comparison with baseline
Time frame: 6 months after start of treatment with the drug
Serum P level at 12 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Fosrenol).
Time frame: 12 months
Serum P level at the conduction of dialysis from 13 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Fosrenol).
Time frame: until the conduction of dialysis(Maximum 2 years)
Serum intact PTH level at 12 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Lanthanum carbonate).
Time frame: 12 months
Serum intact PTH level at the conduction of dialysis from 13 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Lanthanum carbonate).
Time frame: until the conduction of dialysis(Maximum 2 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 23 Feb 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 and Kidney Disease, 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 3 inclusion and 2 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 23 Feb 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/number of episodes of adverse drug reactions and adverse events (time frame: 6 months after start of treatment with the drug). 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 23 Feb 2018.