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

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2012

Interventions

  • 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).
  • 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).

Arms, Groups and Cohorts

  • Experimental: PA21
  • Active Comparator: Sevelamer carbonate

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vifor Pharma
  • Collaborator
    • Fresenius Medical Care North America
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Juergen Floege, MD, Principal Investigator, Medizinische Klinik II

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