Peritoneal DialysisPhase 3NCT01852682
A Phase III Study of PA21 in Peritoneal Dialysis Patients With Hyperphosphatemia
A Phase 3 study testing PA21 in people with Peritoneal Dialysis and Hyperphosphatemia, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to investigate efficacy and safety, when administering PA21, in peritoneal dialysis patients having hyperphosphatemia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peritoneal Dialysis, Hyperphosphatemia
- What is being tested?
- PA21
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteJapan
- Study dates
- Start not givento Mar 2014
- 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
- Adult, Older adult
Who may be able to join
- Receiving stable maintenance peritoneal dialysis
- Peritoneal dialysis patients with hyperphosphatemia
Who cannot join
- Patients having history of a pronounced brain / cardiovascular disorder
- Patients having severe gastrointestinal disorders
- Patients having severe hepatic disorders
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate efficacy and safety, when administering PA21, in peritoneal dialysis patients having hyperphosphatemia.
- Conditions
- Peritoneal Dialysis, Hyperphosphatemia
- Being tested
- PA21
- Keywords
- Peritoneal Dialysis, Hyperphosphatemia
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA21Drug
| Study group | Role | What they receive |
|---|---|---|
| PA21 | Experimental | Not described Receives: Drug: PA21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum phosphate concentrations
Measured: 12 weeks
Secondary outcomes (3)
Incidences of Adverse Events
Measured: 12 weeks
Incidences of Adverse Events
Measured: 28 weeks
Serum phosphate concentrations
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Primary completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852682
- Sponsor's protocol ID
- PA1303
- Status last verified
- Nov 2014
- First submitted
- 7 May 2013
- Last updated
- 13 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of PA21 in Peritoneal Dialysis Patients With Hyperphosphatemia
- ClinicalTrials.gov ID
- NCT01852682
- Acronym / sponsor ID
- PA1303
- Conditions
- Peritoneal Dialysis, Hyperphosphatemia
- Keywords
- Peritoneal Dialysis, Hyperphosphatemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Primary completion
- Mar 2014 (actual)
- First posted
- 14 May 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.
The purpose of this study is to investigate efficacy and safety, when administering PA21, in peritoneal dialysis patients having hyperphosphatemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PA21 | Experimental | Drug: PA21 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Receiving stable maintenance peritoneal dialysis
- Peritoneal dialysis patients with hyperphosphatemia
Key exclusion criteria (3 listed)
- Patients having history of a pronounced brain / cardiovascular disorder
- Patients having severe gastrointestinal disorders
- Patients having severe hepatic disorders
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 |
|---|---|---|
| PA21 | Drug | PA21 |
Primary outcome
Serum phosphate concentrations
Time frame: 12 weeks
3 secondary outcomes
Incidences of Adverse Events
Time frame: 12 weeks
Incidences of Adverse Events
Time frame: 28 weeks
Serum phosphate concentrations
Time frame: 28 weeks
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 13 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PA21 in people with Peritoneal Dialysis and Hyperphosphatemia, run by Kissei Pharmaceutical Co., Ltd. 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 2 inclusion and 3 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 13 Nov 2014. 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.
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?
Serum phosphate concentrations (time frame: 12 weeks). 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 13 Nov 2014.