Chronic Kidney Disease Requiring HemodialysisPhase 2NCT01521494
PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia
A Phase 2 study testing PA21 in people with Chronic Kidney Disease Requiring Hemodialysis, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Kidney Disease Requiring Hemodialysis
- What is being tested?
- PA21
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 1 siteJapan
- Study dates
- 11 Jan 2012to 3 Jul 2012
- Phase
- Phase 2
- 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
- Patients age 20 or older, regardless of gender.
- Receiving stable maintenance hemodialysis 3 times a week.
- Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.
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
To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia.
- Being tested
- PA21, Placebo
- 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
PA21Drug
PA21Drug
PA21Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| PA21 750 mg/day | Experimental | Not described Receives: Drug: PA21 |
| PA21 1500 mg/day | Experimental | Not described Receives: Drug: PA21 |
| PA21 2250 mg/day | Experimental | Not described Receives: Drug: PA21 |
| PA21 3000 mg/day | Experimental | Not described Receives: Drug: PA21 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.
Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.
Measured: 6 weeks
Secondary outcomes (2)
Change From Baseline in Serum Calcium Concentrations.
Measured: 6 weeks
Change From Baseline in Serum Intact-PTH Concentrations.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study start11 Jan 2012
- Primary completion3 Jul 2012
- Study completion3 Jul 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Requiring 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tatsuro Takei, Study director, Clinical Development Department, Kissei pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521494
- Sponsor's protocol ID
- PA1201
- Status last verified
- Nov 2017
- First submitted
- 26 Jan 2012
- Last updated
- 23 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PubMed 40576086
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia
- ClinicalTrials.gov ID
- NCT01521494
- Acronym / sponsor ID
- PA1201
- Keywords
- Hemodialysis, Hyperphosphatemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jan 2012 (actual)
- Primary completion
- 3 Jul 2012 (actual)
- Study completion
- 3 Jul 2012 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Posted 23 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PA21 750 mg/day | Experimental | Drug: PA21 |
| PA21 1500 mg/day | Experimental | Drug: PA21 |
| PA21 2250 mg/day | Experimental | Drug: PA21 |
| PA21 3000 mg/day | Experimental | Drug: PA21 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients age 20 or older, regardless of gender.
- Receiving stable maintenance hemodialysis 3 times a week.
- Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.
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 750 mg/day |
| PA21 | Drug | PA21 1500 mg/day |
| PA21 | Drug | PA21 2250 mg/day |
| PA21 | Drug | PA21 3000 mg/day |
| Placebo | Drug | Placebo |
Primary outcome
Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.
Time frame: 6 weeks
Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.
2 secondary outcomes
Change From Baseline in Serum Calcium Concentrations.
Time frame: 6 weeks
Change From Baseline in Serum Intact-PTH Concentrations.
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40576086Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
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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.
Tatsuro Takei study director
Clinical Development Department, Kissei pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PA21 in people with Chronic Kidney Disease Requiring Hemodialysis, 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 3 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 23 Aug 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 23 Aug 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?
Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01521494, which also lists 1 linked publication.
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 Aug 2018.