Chronic Kidney Disease Requiring Chronic DialysisPhase 3NCT01324128
A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients
A Phase 3 study testing PA21 (2.5 g tablet containing 500 mg iron), Sevelamer carbonate and PA21-1 (1.25 g tablet containing 250 mg iron) in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by Vifor Pharma at 15 sites in 15 countries.
Trial summary
This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate levels in these patients. Read more about this study
- 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), Sevelamer carbonate and PA21-1 (1.25 g tablet containing 250 mg iron)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,059 participants
- Where
- 15 sitesin 15 countries
- Study dates
- Mar 2011to Oct 2012
- 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
- Dialysis patients with hyperphosphataemia (≥ 1.94 mmol/L; ≥ 6.0 mg/dL)
- Stable dose of phosphate binder
- 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.
15 sites in 15 countries
Lithuania1 site
Vilnius University Hospital Santariskiu Clinics
Vilnius, LT-08661
United Kingdom1 site
Dorset County Hospital NHS Foundation Trust
Dorset, DT1 2JY
About this study
Official title: An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 Compared With Sevelamer Carbonate Followed by a Randomised Comparison of PA21 Maintenance Dose Versus PA21-Low Dose in Dialysis Patients With Hyperphosphataemia
This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate levels in these patients.
- Being tested
- PA21 (2.5 g tablet containing 500 mg iron), Sevelamer carbonate, PA21-1 (1.25 g tablet containing 250 mg iron)
- 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
Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day)
PA21-1 (1.25 g tablet containing 250 mg iron)Drug
Low dose comparator (1.25 g/day)
| Study group | Role | What they receive |
|---|---|---|
| PA21 (2.5 g tablet) | Experimental | Not described Receives: Drug: PA21 (2.5 g tablet containing 500 mg iron) |
| Sevelamer carbonate | Active comparator | Not described Receives: Drug: Sevelamer carbonate |
| PA21-1 (1.25 g tablet) | Other | Not described Receives: Drug: PA21-1 (1.25 g tablet containing 250 mg iron) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Phosphorus Levels From Week 24 to Week 27
Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27
Measured: Week 24, Week 27
Secondary outcomes (1)
Change in Serum Phosphorus Levels From Baseline to Week 12
Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group.
Measured: Week 12 post Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2012
- Study completionOct 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 (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
- 1,059 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fresenius Medical Care North America
- Responsible party
- Sponsor
- Investigators
- Juergen Floege, MD, Principal investigator, Medizinische Klinik II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324128
- Sponsor's protocol ID
- PA-CL-05A
- Status last verified
- Apr 2014
- First submitted
- 24 Mar 2011
- Last updated
- 24 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 40576086Sprague 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
Study at a glance
From the registry record, last updated by the sponsor on 24 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 Safety and Efficacy of PA21 Compared With Sevelamer Carbonate Followed by a Randomised Comparison of PA21 Maintenance Dose Versus PA21-Low Dose in Dialysis Patients With Hyperphosphataemia
- ClinicalTrials.gov ID
- NCT01324128
- Acronym / sponsor ID
- PA-CL-05A
- Keywords
- PA21, Phosphate Binder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,059 participants (actual)
- Lead sponsor
- Vifor PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Fresenius Medical Care North America
- Study start
- Mar 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Mar 2011 (estimated)
- Results
- Posted 1 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate levels in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PA21 (2.5 g tablet) | Experimental | Drug: PA21 (2.5 g tablet containing 500 mg iron) |
| Sevelamer carbonate | Active comparator | Drug: Sevelamer carbonate |
| PA21-1 (1.25 g tablet) | Other | Drug: PA21-1 (1.25 g tablet containing 250 mg iron) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dialysis patients with hyperphosphataemia (≥ 1.94 mmol/L; ≥ 6.0 mg/dL)
- Stable dose of phosphate binder
- 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 (2.5 g tablet) |
| Sevelamer carbonateDose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day) | Drug | Sevelamer carbonate |
| PA21-1 (1.25 g tablet containing 250 mg iron)Low dose comparator (1.25 g/day) | Drug | PA21-1 (1.25 g tablet) |
Primary outcome
Change in Serum Phosphorus Levels From Week 24 to Week 27
Time frame: Week 24, Week 27
Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27
1 secondary outcome
Change in Serum Phosphorus Levels From Baseline to Week 12
Time frame: Week 12 post Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 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.
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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.
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?
A Phase 3 study testing PA21 (2.5 g tablet containing 500 mg iron), Sevelamer carbonate and PA21-1 (1.25 g tablet containing 250 mg iron) in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by Vifor Pharma at 15 sites in 15 countries.
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 24 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 1 Apr 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 in Serum Phosphorus Levels From Week 24 to Week 27 (time frame: Week 24, Week 27). 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 NCT01324128, 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 24 Apr 2014.