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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