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NCT01464190 · ClinicalTrials.gov registry record · Phase 3
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 of Chronic Kidney Disease Requiring Chronic Dialysis, sponsored by Vifor Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 659
- Enrollment target
- 15
- Study locations
NCT01464190: Completed Phase 3 study of Chronic Kidney Disease Requiring Chronic Dialysis, sponsored by Vifor Pharma.
NCT01464190 is a Phase 3 study of Chronic Kidney Disease Requiring Chronic Dialysis that has completed, run by Vifor Pharma. The registered enrollment target is 659 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower). The trial reports 15 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01464190, a Phase 3 study of Chronic Kidney Disease Requiring Chronic Dialysis, has completed, sponsored by Vifor Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 659 participants
- Enrollment target
- 15
- Study locations
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.
Primary Outcome
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
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 |
What the finished NCT01464190 record still lists
NCT01464190 is an interventional study that assigns participants to a tested intervention. The registered 659 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower).
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.
NCT01464190 lists 15 locations in 2 states (Other, Texas).
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.
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).
Who is sponsoring clinical trial NCT01464190?
This trial is sponsored by Vifor Pharma, which has 12 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01464190's enrollment target sits among peer trials
659 561st of 2000 higher than 1,438 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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