Chronic Kidney DiseaseNCT02805348
Post-marketing Surveillance of Bixalomer in Patients With Pre-dialysis Chronic Kidney Disease
An observational study of Chronic Kidney Disease, run by Astellas Pharma Inc at 14 sites in Japan.
Trial summary
The objective of this study is to assess the long-term safety and efficacy of bixalomer under post-marketed setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Bixalomer
- Type of treatment
- Pill or oral medicine
- How many people
- 144 participants
- Where
- 14 sitesJapan
- Study dates
- 1 Jun 2016to 31 Dec 2018
- 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: Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time
Who may be able to join
- Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time
Who cannot join
None listed.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Japan14 sites
Site JP00006
Aichi
Site JP00010
Ehime
Site JP00012
Fukuoka
Site JP00004
Gifu
Site JP00001
Ibaraki
Site JP00009
Kagawa
Site JP00003
Kanagawa
Site JP00011
Kochi
Site JP00014
Kumamoto
Site JP00013
Nagasaki
Site JP00007
Osaka
Site JP00005
Shizuoka
Site JP00002
Tochigi
Site JP00008
Wakayama
About this study
Official title: Long-Term Specified Drug Use-Results Survey in Patients With Pre-dialysis Chronic Kidney Disease
The objective of this study is to assess the long-term safety and efficacy of bixalomer under post-marketed setting.
- Conditions
- Chronic Kidney Disease
- Being tested
- Bixalomer
- Keywords
- Kiklin, Bixalomer, Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BixalomerDrug
Also called ASP1585, AMG223, Kiklin, ILY101
Oral
| Study group | Role | What they receive |
|---|---|---|
| Chronic kidney disease | Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time. Receives: Drug: Bixalomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the serum concentrations of phosphate
Measured: Baseline and up to Month 12
Change from baseline in the corrected serum concentrations of calcium
Measured: Baseline and up to Month 12
Change from baseline in the serum concentrations of intact parathyroid hormone
Measured: Baseline and up to Month 12
Safety assessed by incidence of adverse events
Measured: Up to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start1 Jun 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805348
- Sponsor's protocol ID
- 1585-MA-3052
- Status last verified
- Apr 2019
- First submitted
- 16 Jun 2016
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Specified Drug Use-Results Survey in Patients With Pre-dialysis Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02805348
- Acronym / sponsor ID
- 1585-MA-3052
- Conditions
- Chronic Kidney Disease
- Keywords
- Kiklin, Bixalomer, Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 20 Jun 2016 (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 assess the long-term safety and efficacy of bixalomer under post-marketed setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic kidney disease | – | Drug: BixalomerPatients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time
Key inclusion criteria (1 listed)
- Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| BixalomerAlso: ASP1585, AMG223, Kiklin, ILY101Oral | Drug | Chronic kidney disease |
Primary outcome
Change from baseline in the serum concentrations of phosphate
Time frame: Baseline and up to Month 12
Change from baseline in the corrected serum concentrations of calcium
Time frame: Baseline and up to Month 12
Change from baseline in the serum concentrations of intact parathyroid hormone
Time frame: Baseline and up to Month 12
Safety assessed by incidence of adverse events
Time frame: Up to Month 12
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 16 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Central Contact study director
Astellas Pharma Inc
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Astellas Pharma Inc at 14 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 0 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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.
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 the serum concentrations of phosphate (time frame: Baseline and up to Month 12). The study lists 4 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 16 Oct 2024.