Status:
COMPLETED
A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients
Lead Sponsor:
Vifor Pharma
Collaborating Sponsors:
Fresenius Medical Care North America
Conditions:
Chronic Kidney Disease Requiring Chronic Dialysis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 dialysi...
Eligibility Criteria
Inclusion
- Subjects who have completed treatment in Protocol PA-CL-05A
- Written Informed Consent
Exclusion
- Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)
- Other significant medical conditions
- Pregnancy
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
659 Patients enrolled
Trial Details
Trial ID
NCT01464190
Start Date
September 1 2011
End Date
April 1 2013
Last Update
April 1 2014
Active Locations (15)
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1
San Antonio, Texas, United States, 78215
2
Medizinische Abteilung Nephrologie und Dialyse
Sankt Pölten, Austria, 3100
3
CHU Sart Tilman
Liège, Belgium, 4000
4
Clinical Hospital Center Rijeka
Rijeka, Croatia, 51000