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Completed

NCT Number: NCT01464190

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 enrolled and have been treated with study medication for at least 24 weeks.

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Key information

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medizinische Abteilung Nephrologie und Dialyse, Sankt Pölten, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PA21 (2.5 g tablet containing 500 mg iron)

Drug

Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).

Sevelamer carbonate

Drug

Film coated, compressed tablets. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Vifor Pharma

Industry

Collaborators

  • Fresenius Medical Care North America

Registry information

Official study title

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)

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Nov 3, 2011
Registry last updated
Apr 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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