Chronic Kidney Disease Requiring Chronic DialysisPhase 3NCT01464190

A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients

A Phase 3 study testing PA21 (2.5 g tablet containing 500 mg iron) and Sevelamer carbonate in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by Vifor Pharma at 15 sites in 15 countries.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease Requiring Chronic Dialysis
What is being tested?: PA21 (2.5 g tablet containing 500 mg iron) and Sevelamer carbonate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 659 participants
Where: 15 sitesin 15 countries
Study dates: Sep 2011to Apr 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects who have completed treatment in Protocol PA-CL-05A
Written Informed Consent

Who cannot join

Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)
Other significant medical conditions
Pregnancy

Trial locations and contacts

15 sites in 15 countries.

Country

City, postcode or hospital

15 sites in 15 countries

United States1 site

Study site
San Antonio, Texas, 78215

Other trials in United States

Austria1 site

Medizinische Abteilung Nephrologie und Dialyse
Sankt Pölten, 3100

Other trials in Austria

Belgium1 site

CHU Sart Tilman
Liège, 4000

Other trials in Belgium

Croatia1 site

Clinical Hospital Center Rijeka
Rijeka, 51000

Other trials in Croatia

Czechia1 site

Hospital with Polyclinic Novy Jicin
Nový Jičín, 74101

Other trials in Czechia

Germany1 site

KfH Nierenzentrum Berlin-Neukoelln
Berlin, 12045

Other trials in Germany

Latvia1 site

Vidzemes Hospital
Valmiera, LV-4201

Other trials in Latvia

Lithuania1 site

JSC "Diaverum Clinics"
Klaipėda, LT-93220

Other trials in Lithuania

Poland1 site

Teaching Hospital no.1 of Medical University of Lodz
Lodz, 90-153

Other trials in Poland

Romania1 site

Dialmed Clinic SRL
Sibiu, 550135

Other trials in Romania

Russia1 site

Kemerovo Regional hospital
Kemerovo, 650029

Other trials in Russia

Serbia1 site

Zvezdara Clinical Medical Center
Belgrade, 11000

Other trials in Serbia

South Africa1 site

St Augustines Hospital
Durban, 4001

Other trials in South Africa

Ukraine1 site

Mykolayiv Regional Hospital
Mykolayiv, 54058

Other trials in Ukraine

United Kingdom1 site

Dorset County Hospital NHS Foundation Trust
Dorset, DT1 2JY

Other trials in United Kingdom

About this study

Official title: An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Phase 3 Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21 Compared With Sevelamer Carbonate in Dialysis Patients With Hyperphosphataemia. Extension Study for Protocol PA-CL-05A (NCT01324128)

This is a Phase 3, randomised, active controlled, multicentre extension study to investigate the long-term safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. This is an extension study to PA-CL-05A (NCT01324128), subjects have already been enrolled and have been treated with study medication for at least 24 weeks.

Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Being tested: PA21 (2.5 g tablet containing 500 mg iron), Sevelamer carbonate
Keywords: PA21, Phosphate Binder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PA21 (2.5 g tablet containing 500 mg iron)Drug
Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
Sevelamer carbonateDrug
Film coated, compressed tablets. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).

Study groups in NCT01464190
Study group	Role	What they receive
PA21	Experimental	Not described Receives: Drug: PA21 (2.5 g tablet containing 500 mg iron)
Sevelamer carbonate	Active comparator	Not described Receives: Drug: Sevelamer carbonate

What is being measured

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

Change From Baseline and Levels at Each Time Point for Serum Phosphorus
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Measured: Every 4 weeks from baseline to Week 28
Change From Baseline and Levels at Each Time Point for Serum Calcium
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Measured: Every 4 weeks from baseline to Week 28
Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Measured: Every 4 weeks from baseline to Week 28

Timeline

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

Sep 2011Apr 2013

First posted3 Nov 2011 (estimated)
Study startSep 2011
Primary completionOct 2012
Study completionApr 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 (2)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney Disease Requiring Chronic 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 659 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01464190
Sponsor's protocol ID: PA-CL-05B
Status last verified: Mar 2014
First submitted: 12 Sep 2011
Last updated: 1 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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
Sprague SM, Ketteler M, Covic AC, Floege J, Rakov V, Walpen S, Rastogi A. Long-term efficacy and safety of sucroferric oxyhydroxide in African American dialysis patients. Hemodial Int. 2018 Oct;22(4):480-491. doi: 10.1111/hdi.12663. Epub 2018 Apr 15.
PubMed 29656600

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?

See locations

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A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
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All Chronic Kidney Disease Requiring Chronic Dialysis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Phase 3 Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21 Compared With Sevelamer Carbonate in Dialysis Patients With Hyperphosphataemia. Extension Study for Protocol PA-CL-05A (NCT01324128)
ClinicalTrials.gov ID: NCT01464190
Acronym / sponsor ID: PA-CL-05B
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: PA21, Phosphate Binder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 659 participants (actual)
Lead sponsor: Vifor PharmaIndustry (pharma, biotech, devices)
Collaborators: Fresenius Medical Care North America
Study start: Sep 2011
Primary completion: Oct 2012 (actual)
Study completion: Apr 2013 (actual)
First posted: 3 Nov 2011 (estimated)
Results: Posted 17 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 (2.5 g tablet containing 500 mg iron)
Sevelamer carbonate	Active comparator	Drug: Sevelamer carbonate

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subjects who have completed treatment in Protocol PA-CL-05A
Written Informed Consent

Key exclusion criteria (3 listed)

Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)
Other significant medical conditions
Pregnancy

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 (2.5 g tablet containing 500 mg iron)Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).	Drug	PA21
Sevelamer carbonateFilm coated, compressed tablets. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).	Drug	Sevelamer carbonate

Primary outcome

Change From Baseline and Levels at Each Time Point for Serum Phosphorus
Time frame: Every 4 weeks from baseline to Week 28
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Change From Baseline and Levels at Each Time Point for Serum Calcium
Time frame: Every 4 weeks from baseline to Week 28
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)
Time frame: Every 4 weeks from baseline to Week 28
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.

Results and safety

Results posted to the registry on 17 Feb 2014, 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	391	322
Sevelamer Carbonate	268	227

Primary outcome: Change From Baseline and Levels at Each Time Point for Serum Phosphorus

Time frame: Every 4 weeks from baseline to Week 28. Mean (Standard Deviation). Unit: mg/dL

Measure	PA21 n = 384	Sevelamer Carbonate n = 260
Change from Baseline to Week 4 (n = 346, 236)	-0.2 (1.33)	-0.1 (1.47)
Change from Baseline to Week 8 (n = 325, 238)	-0.2 (1.38)	0.1 (1.56)
Change from Baseline to Week 12 (n = 322, 242)	-0.0 (1.43)	0.2 (1.55)
Change from Baseline to Week 16 (n = 313, 228)	0.0 (1.57)	0.2 (1.75)
Change from Baseline to Week 20 (n = 300, 221)	-0.0 (1.46)	0.1 (1.44)
Change from Baseline to Week 24 (n = 286, 208)	0.1 (1.53)	0.2 (1.78)
Chnage from Baseline to Week 28 (n = 287, 210)	0.2 (1.52)	0.2 (1.76)
Change from Baseline to Endpoint (n = 384, 260)	0.1 (1.62)	0.3 (1.79)

Population analysed: For the Primary Outcome, data from the Full Analysis Set for PA-CL-05B (FAS5B) was used. The FAS5B consists of all subjects who enrolled in PA-CL-05B, received at least 1 dose of PA-CL-05B medication, and had at least 1 efficacy assessment after the PA-CL-05B study entry visit.

Primary outcome: Change From Baseline and Levels at Each Time Point for Serum Calcium

Time frame: Every 4 weeks from baseline to Week 28. Mean (Standard Deviation). Unit: mg/dL

Measure	PA21 n = 384	Sevelamer Carbonate n = 260
Change from Baseline to Week 4 (n = 346, 236	-1.2 (12.07)	-0.8 (13.37)
Change from Baseline to Week 8 (n = 325, 238)	-1.2 (12.30)	1.5 (14.40)
Change from Baseline to Week 12 (n = 321, 242)	0.1 (12.94)	1.9 (13.79)
Change from Baseline to Week 16 (n = 313, 228)	0.5 (14.04)	2.0 (16.05)
Change from Baseline to Week 20 (n = 300, 221)	0.4 (13.24)	1.6 (13.29)
Change from Baseline to Week 24 (n = 284, 207)	1.1 (13.57)	2.2 (15.74)
Change from Baseline to Week 28 (n = 286, 210)	2.3 (13.52)	2.3 (16.39)
Change from Baseline to Endpoint (n = 365, 258)	1.5 (13.86)	2.9 (16.68)

Primary outcome: Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)

Time frame: Every 4 weeks from baseline to Week 28. Mean (Standard Deviation). Unit: pg/mL

Measure	PA21 n = 384	Sevelamer Carbonate n = 260
Change from Baseline to Week 4 (n = 365, 252)	11.8 (177.39)	25.9 (186.42)
Change from Baseline to Week 8 (n = 362, 258)	8.6 (204.39)	40.8 (201.18)
Change from Baseline to Week 12 (n = 352, 252)	28.9 (315.81)	64.1 (204.11)
Change from Baseline to Week 16 (n = 341, 241)	54.5 (352.92)	52.3 (210.35)
Change from Baseline to Week 20 (n = 334, 236)	28.0 (233.13)	72.1 (228.03)
Change from Baseline to Week 24 (n = 320, 226)	27.7 (271.31)	79.6 (253.65)
Change from Baseline to Week 28 (n = 310, 222)	53.0 (287.19)	71.5 (278.03)
Change from Baseline to Endpoint (n = 381, 260)	52.3 (273.14)	67.5 (270.06)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PA21	78 of 391 (19.9%)	208 of 391 (53.2%)	Not reported
Sevelamer Carbonate	52 of 267 (19.5%)	169 of 267 (63.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
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.
Derived from this study: PubMed 29656600Sprague SM, Ketteler M, Covic AC, Floege J, Rakov V, Walpen S, Rastogi A. Long-term efficacy and safety of sucroferric oxyhydroxide in African American dialysis patients. Hemodial Int. 2018 Oct;22(4):480-491. doi: 10.1111/hdi.12663. Epub 2018 Apr 15.

Related trials for Chronic Kidney Disease Requiring Chronic Dialysis

Recruiting
DIALysis With EXpanded Solute Removal
Chronic Kidney Disease Requiring Hemodialysis, End-Stage Kidney Disease (ESKD)
RecruitingPhase 2
A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
Hyperphosphatemia, Chronic Kidney Disease Requiring Chronic Dialysis
Recruiting
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Recruiting
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Recruiting
Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
Kidney Disease, End-Stage, End-stage Renal Disease

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.

Juergen Floege, MD principal investigator

Medizinische Klinik II

15 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Austria, Belgium, Croatia, Czechia and 10 more countries. 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 17 Feb 2014). 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 and Levels at Each Time Point for Serum Phosphorus (time frame: Every 4 weeks from baseline to Week 28). The study lists 3 primary outcomes in all. 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 NCT01464190, which also lists 2 linked publications.

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 1 Apr 2014.