A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients

March 3, 2014 updated by: Vifor Pharma

An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Phase 3 Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21 Compared With Sevelamer Carbonate in Dialysis Patients With Hyperphosphataemia. Extension Study for Protocol PA-CL-05A (NCT01324128)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

659

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • St. Pölten, Austria, 3100
        • Medizinische Abteilung Nephrologie und Dialyse
  • Belgium
      • Liege, Belgium, 4000
        • CHU Sart Tilman
  • Croatia
      • Rijeka, Croatia, 51000
        • Clinical Hospital Center Rijeka
  • Czech Republic
      • Novy Jicin, Czech Republic, 74101
        • Hospital with Polyclinic Nový Jičín
  • Germany
      • Berlin, Germany, 12045
        • KfH Nierenzentrum Berlin-Neukoelln
  • Latvia
      • Valmiera, Latvia, LV-4201
        • Vidzemes Hospital
  • Lithuania
      • Klaipeda, Lithuania, LT-93220
        • JSC "Diaverum Clinics"
  • Poland
      • Lodz, Poland, 90-153
        • Teaching Hospital no.1 of Medical University of Lodz
  • Romania
      • Sibiu, Romania, 550135
        • Dialmed Clinic SRL
  • Russian Federation
      • Kemerovo, Russian Federation, 650029
        • Kemerovo Regional hospital
  • Serbia
      • Belgrade, Serbia, 11000
        • Zvezdara Clinical Medical Center
  • South Africa
      • Durban, South Africa, 4001
        • St Augustines Hospital
  • Ukraine
      • Mykolayiv, Ukraine, 54058
        • Mykolayiv Regional Hospital
  • United Kingdom
      • Dorset, United Kingdom, DT1 2JY
        • Dorset County Hospital NHS Foundation Trust
  • United States
    • Texas
      • San Antonio, Texas, United States, 78215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who have completed treatment in Protocol PA-CL-05A
  • Written Informed Consent

Exclusion Criteria:

  • Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)
  • Other significant medical conditions
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PA21
Drug: PA21 (2.5 g tablet containing 500 mg iron)
Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
Active Comparator: Sevelamer carbonate
Drug: Sevelamer carbonate
Film coated, compressed tablets. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline and Levels at Each Time Point for Serum Phosphorus
Time Frame: Every 4 weeks from baseline to Week 28
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Every 4 weeks from baseline to Week 28
Change From Baseline and Levels at Each Time Point for Serum Calcium
Time Frame: Every 4 weeks from baseline to Week 28
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Every 4 weeks from baseline to Week 28
Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)
Time Frame: Every 4 weeks from baseline to Week 28
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Every 4 weeks from baseline to Week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vifor Pharma

Collaborators

Fresenius Medical Care North America

Investigators

  • Principal Investigator: Juergen Floege, MD, Medizinische Klinik II

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

September 12, 2011

First Submitted That Met QC Criteria

October 31, 2011

First Posted (Estimate)

November 3, 2011

Study Record Updates

Last Update Posted (Estimate)

April 1, 2014

Last Update Submitted That Met QC Criteria

March 3, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA-CL-05B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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