A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients

April 3, 2014 updated by: Vifor Pharma

An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 Compared With Sevelamer Carbonate Followed by a Randomised Comparison of PA21 Maintenance Dose Versus PA21-Low Dose in Dialysis Patients With Hyperphosphataemia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1059

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. Polten, Austria, 3100
        • LKH St. Pölten
  • Belgium
      • Liege, Belgium, 4000
        • CHU Sart Tilman
  • Croatia
      • Rijeka, Croatia, 51000
        • Clinical Hospital Center Rijeka
  • Czech Republic
      • Sokolov, Czech Republic, 35601
        • Dialysis Centre Fresenius Medical Care
  • Germany
      • Berlin, Germany, 12045
        • KfH Nierenzentrum Berlin-Neukoelln
  • Latvia
      • Valmiera, Latvia, LV-4201
        • Vidzemes Hospital
  • Lithuania
      • Vilnius, Lithuania, LT-08661
        • Vilnius University Hospital Santariskiu Clinics
  • Poland
      • Lodz, Poland, 90-153
        • Teaching Hospital no.1 of Medical University of Lodz
  • Romania
      • Sibiu, Romania, 550135
        • Dialmed Clinic SRL
  • Russian Federation
      • St. Petersburg, Russian Federation, 191104
        • City Mariinsky Hospital
  • Serbia
      • Belgrade, Serbia, 11000
        • Zvezdara Clinical Medical Center
  • South Africa
      • Benoni, South Africa, 1500
        • Lakeview 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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Dialysis patients with hyperphosphataemia (≥ 1.94 mmol/L; ≥ 6.0 mg/dL)
  • Stable dose of phosphate binder
  • 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 (2.5 g tablet)
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
Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day)
Other: PA21-1 (1.25 g tablet)
Drug: PA21-1 (1.25 g tablet containing 250 mg iron)
Low dose comparator (1.25 g/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum Phosphorus Levels From Week 24 to Week 27
Time Frame: Week 24, Week 27
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
Week 24, Week 27

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum Phosphorus Levels From Baseline to Week 12
Time Frame: Week 12 post Baseline
Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group.
Week 12 post Baseline

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

March 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

March 24, 2011

First Submitted That Met QC Criteria

March 25, 2011

First Posted (Estimate)

March 28, 2011

Study Record Updates

Last Update Posted (Estimate)

April 24, 2014

Last Update Submitted That Met QC Criteria

April 3, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA-CL-05A

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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