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NCT01324128 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients
A Phase 3 study, sponsored by Vifor Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,059
- Enrollment target
NCT01324128: Completed Phase 3 study, sponsored by Vifor Pharma.
NCT01324128 is a Phase 3 study that has completed, run by Vifor Pharma. The registered enrollment target is 1,059 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01324128, a Phase 3 study, has completed, sponsored by Vifor Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,059 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG PA21 (2.5 g tablet containing 500 mg iron)
- DRUG Sevelamer carbonate
- DRUG PA21-1 (1.25 g tablet containing 250 mg iron)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,059 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-10 |
| Phase | Phase 3 |
What the finished NCT01324128 record still lists
NCT01324128 is an interventional study that assigns participants to a tested intervention. Its 1,059 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 3 interventions - of which PA21 (2.5 g tablet containing 500 mg iron) is the first listed.
NCT01324128 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01324128 about?
NCT01324128 is a clinical study titled "A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients". 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.
What is the current status of trial NCT01324128?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,059 participants. The study started on 2011-03. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01324128?
The interventions under investigation include: PA21 (2.5 g tablet containing 500 mg iron) (DRUG), Sevelamer carbonate (DRUG), PA21-1 (1.25 g tablet containing 250 mg iron) (DRUG).
Who is sponsoring clinical trial NCT01324128?
This trial is sponsored by Vifor Pharma, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01324128's enrollment target sits among peer trials
1,059 275th of 2000 higher than 1,725 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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