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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 is a Phase 3 study that has completed, run by Vifor Pharma. The registered enrollment target is 1,059 participants.

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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.

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

FieldValue
Enrollment Target 1,059 participants
Start Date 2011-03
Est. Completion 2012-10
Phase Phase 3

Sponsor

Vifor Pharma

12 total trials

What the Registry Record Tells You About NCT01324128

The ClinicalTrials.gov registry entry for NCT01324128 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,059 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vifor Pharma, which has 12 total studies on file at ClinicalTrials.gov.

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 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.