HemodialysisPhase 3NCT01850602

A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia

A Phase 3 study testing PA21 and Sevelamer hydrochloride in people with Hemodialysis and Hyperphosphatemia, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia 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 and Sevelamer hydrochloride
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 213 participants
Where: 1 siteJapan
Study dates: 23 Apr 2013to 10 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

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.

Japan1 site

Study site
Multiple Locations

Other trials in Japan

About this study

The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia

Conditions: Hemodialysis, Hyperphosphatemia
Being tested: PA21, Sevelamer hydrochloride
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
Sevelamer hydrochlorideDrug

Study groups in NCT01850602
Study group	Role	What they receive
PA21	Experimental	Not described Receives: Drug: PA21
Sevelamer hydrochloride	Active comparator	Not described Receives: Drug: Sevelamer hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment
Covariate: Serum phosphorus concentrations at baseline.
Measured: 12 weeks

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Apr 201310 Dec 2013

First posted9 May 2013 (estimated)
Study start23 Apr 2013
Primary completionDec 2013
Study completion10 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.
Publications (1)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 213 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01850602
Sponsor's protocol ID: PA1301
Status last verified: Nov 2014
First submitted: 7 May 2013
Last updated: 9 Oct 2018
Results posted: Yes, on ClinicalTrials.gov

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Hemodialysis trials

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 in Hemodialysis Patients With Hyperphosphatemia
ClinicalTrials.gov ID: NCT01850602
Acronym / sponsor ID: PA1301
Conditions: Hemodialysis, Hyperphosphatemia
Keywords: Hemodialysis, Hyperphosphatemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 213 participants (actual)
Lead sponsor: Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 23 Apr 2013 (actual)
Primary completion: Dec 2013 (actual)
Study completion: 10 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 evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PA21	Experimental	Drug: PA21
Sevelamer hydrochloride	Active comparator	Drug: Sevelamer hydrochloride

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
Sevelamer hydrochloride	Drug	Sevelamer hydrochloride

Primary outcome

Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment
Time frame: 12 weeks
Covariate: Serum phosphorus concentrations at baseline.

3 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

Results and safety

Results posted to the registry on 9 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PA21	108	94
Sevelamer Hydrochloride	105	87

Primary outcome: Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment

Time frame: 12 weeks. Mean (95% Confidence Interval). Unit: mg/dL

Measure	PA21 n = 100	Sevelamer Hydrochloride n = 92
Value	5.00 (4.80 to 5.19)	5.34 (5.13 to 5.55)

PA21 vs Sevelamer Hydrochloride: Mean Difference (Final Values): -0.34 (95% CI -0.63 to -0.05), p = 0.020, ANCOVA

Population analysed: Per Protocol Set

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PA21	6 of 108 (5.6%)	47 of 108 (43.5%)	0 of 108
Sevelamer Hydrochloride	5 of 105 (4.8%)	42 of 105 (40%)	0 of 105

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.
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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Active, not recruiting
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Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
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Recruiting
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Not yet recruiting
Evaluation of the Effect of Light Therapy on the Evolution of Self-reported Depressive Disorders in Chronic Hemodialysis Patients
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Not yet recruitingObservational study
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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 and Sevelamer hydrochloride 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 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 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?

Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment (time frame: 12 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 NCT01850602, 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 9 Oct 2018; AzTrials last refreshed its copy on 8 Nov 2026.