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A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients
NCT01464190 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DRUG PA21 (2.5 g tablet containing 500 mg iron)
- DRUG Sevelamer carbonate
Study Locations (15)
Other
- Medizinische Abteilung Nephrologie und Dialyse — Sankt Pölten
- CHU Sart Tilman — Liège
- Clinical Hospital Center Rijeka — Rijeka
- Hospital with Polyclinic Novy Jicin — Nový Jičín
- KfH Nierenzentrum Berlin-Neukoelln — Berlin
- Vidzemes Hospital — Valmiera
- JSC "Diaverum Clinics" — Klaipėda
- Teaching Hospital no.1 of Medical University of Lodz — Lodz
- Dialmed Clinic SRL — Sibiu
- Kemerovo Regional hospital — Kemerovo
- Zvezdara Clinical Medical Center — Belgrade
- St Augustines Hospital — Durban
- Mykolayiv Regional Hospital — Mykolayiv
- Dorset County Hospital NHS Foundation Trust — Dorset
Texas
- — San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 659 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01464190
The ClinicalTrials.gov registry entry for NCT01464190 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 659 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vifor Pharma, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Kidney Disease Requiring Chronic Dialysis appearing as the primary indexed condition, and to 2 interventions — of which PA21 (2.5 g tablet containing 500 mg iron) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01464190 reports 15 study locations spanning 2 distinct geographic areas — top geographies include Other, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01464190 about?
NCT01464190 is a clinical study titled "A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients". 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 enroll...
What is the current status of trial NCT01464190?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 659 participants. The study started on 2011-09. Estimated completion is 2013-04.
What conditions does trial NCT01464190 study?
This clinical trial studies the following conditions: Chronic Kidney Disease Requiring Chronic Dialysis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01464190?
The interventions under investigation include: PA21 (2.5 g tablet containing 500 mg iron) (DRUG), Sevelamer carbonate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01464190?
This trial is sponsored by Vifor Pharma, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01464190 being conducted?
This trial has 15 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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