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Completed

NCT Number: NCT01324128

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.

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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

LKH St. Polten, Sankt Pölten, Austria

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Who can participate

Healthy volunteers accepted: No

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

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

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

Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day)

PA21-1 (1.25 g tablet containing 250 mg iron)

Drug

Low dose comparator (1.25 g/day)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

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 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 28, 2011
Registry last updated
Apr 24, 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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