A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability 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 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.
Key facts
- Study ID
- NCT01464190
- Run by
- Vifor Pharma
- People needed
- 659
- Starts
- 2011-09-01
- Expected to finish
- 2013-04-01
- Last updated by the study team
- 2014-04-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects who have completed treatment in Protocol PA-CL-05A
- 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
- Medizinische Abteilung Nephrologie und Dialyse — Sankt Pölten, Austria
- CHU Sart Tilman — Liège, Belgium
- Clinical Hospital Center Rijeka — Rijeka, Croatia
- Hospital with Polyclinic Novy Jicin — Nový Jičín, Czechia
- KfH Nierenzentrum Berlin-Neukoelln — Berlin, Germany
- Vidzemes Hospital — Valmiera, Latvia
- JSC "Diaverum Clinics" — Klaipėda, Lithuania
- Teaching Hospital no.1 of Medical University of Lodz — Lodz, Poland
- Dialmed Clinic SRL — Sibiu, Romania
- Kemerovo Regional hospital — Kemerovo, Russia
- Zvezdara Clinical Medical Center — Belgrade, Serbia
- St Augustines Hospital — Durban, 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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