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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 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. The trial reports 15 study locations across 2 states.

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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.

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

FieldValue
Enrollment Target 659 participants
Start Date 2011-09
Est. Completion 2013-04
Phase Phase 3

Sponsor

Vifor Pharma

12 total trials

What the Registry Record Tells You About NCT01464190

The ClinicalTrials.gov registry entry for NCT01464190 describes a study currently listed as completed, categorized as Phase 3. 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 12 total studies on file at ClinicalTrials.gov.

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 reports 15 study locations spanning 2 distinct geographic areas - top geographies include 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.

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.