A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients
Completed · Phase 3
Conditions studied: Chronic Kidney Disease Requiring Chronic Dialysis
In brief
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.
Key facts
- Study ID
- NCT01324128
- Run by
- Vifor Pharma
- People needed
- 1059
- Starts
- 2011-03-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2014-04-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Dialysis patients with hyperphosphataemia (≥ 1.94 mmol/L; ≥ 6.0 mg/dL)
- Stable dose of phosphate binder
- Written informed consent
You may not qualify if…
- Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)
- Other significant medical conditions
- Pregnancy
Where it is running
- Study site — San Antonio, Texas, United States
- LKH St. Polten — Sankt Pölten, Austria
- CHU Sart Tilman — Liège, Belgium
- Clinical Hospital Center Rijeka — Rijeka, Croatia
- Dialysis Centre Fresenius Medical Care — Sokolov, Czechia
- KfH Nierenzentrum Berlin-Neukoelln — Berlin, Germany
- Vidzemes Hospital — Valmiera, Latvia
- Vilnius University Hospital Santariskiu Clinics — Vilnius, Lithuania
- Teaching Hospital no.1 of Medical University of Lodz — Lodz, Poland
- Dialmed Clinic SRL — Sibiu, Romania
- City Mariinsky Hospital — Saint Petersburg, Russia
- Zvezdara Clinical Medical Center — Belgrade, Serbia
- Lakeview Hospital — Benoni, South Africa
- Mykolayiv Regional Hospital — Mykolayiv, Ukraine
- Dorset County Hospital NHS Foundation Trust — Dorset, United Kingdom
Full record on ClinicalTrials.gov
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