HemodialysisPhase 3NCT01850641
A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia
A Phase 3 study testing PA21 in people with Hemodialysis and Hyperphosphatemia, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to investigate the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hemodialysis, Hyperphosphatemia
- What is being tested?
- PA21
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteJapan
- Study dates
- 29 Apr 2013to 3 Dec 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving stable maintenance hemodialysis 3 times a week
- 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 the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.
- Conditions
- Hemodialysis, Hyperphosphatemia
- Being tested
- PA21
- Keywords
- Hemodialysis, 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.
Incidence of Adverse Events
Measured: 12 weeks
Secondary outcomes (8)
Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)
Measured: 12 weeks
Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)
Measured: 12 weeks
Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)
Measured: 12 weeks
Serum Ferritin Concentrations at End of Treatment (Actual Measured Value)
Measured: 12 weeks
TSAT at End of Treatment (Actual Measured Value)
Measured: 12 weeks
Hb Concentrations at End of Treatment (Actual Measured Value)
Measured: 12 weeks
Constipation Condition
Measured: 12 weeks
Satisfaction With Bowel Movement
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study start29 Apr 2013
- Primary completionDec 2013
- Study completion3 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HemodialysisStudies 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)
- Enrolment
- 35 participants (actual)
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
- NCT01850641
- Sponsor's protocol ID
- PA1304
- Status last verified
- Nov 2014
- First submitted
- 7 May 2013
- Last updated
- 9 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia
- ClinicalTrials.gov ID
- NCT01850641
- Acronym / sponsor ID
- PA1304
- Conditions
- Hemodialysis, Hyperphosphatemia
- Keywords
- Hemodialysis, Hyperphosphatemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2013 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- 3 Dec 2013 (actual)
- First posted
- 9 May 2013 (estimated)
- Results
- Posted 9 Oct 2018
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 the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.
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
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Receiving stable maintenance hemodialysis 3 times a week
- 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
Incidence of Adverse Events
Time frame: 12 weeks
8 secondary outcomes
Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)
Time frame: 12 weeks
Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)
Time frame: 12 weeks
Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)
Time frame: 12 weeks
Serum Ferritin Concentrations at End of Treatment (Actual Measured Value)
Time frame: 12 weeks
TSAT at End of Treatment (Actual Measured Value)
Time frame: 12 weeks
Hb Concentrations at End of Treatment (Actual Measured Value)
Time frame: 12 weeks
Constipation Condition
Time frame: 12 weeks
Satisfaction With Bowel Movement
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Hemodialysis 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 9 Oct 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.
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?
Yes. Results are posted in the registry (first posted 9 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Events (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 9 Oct 2018.